EmPOWERing Active Seniors With Energy
Phase: NA
Conditions: Amputation
Sponsor: Otto Bock Healthcare Products GmbH

 
  
BionX Medical Technologies, Inc.                                      
 Confidential                                                                                   Page 1 of 33 
 
EASE Study Protocol P16-01 v. 5 
  
 
 
 
EASE Study Protocol Synopsis 
Protocol Number: P16-01 
NCT #02958553 
 
 
 
Sponsor: 
 
Otto Bock HealthCare LP 
 
 
Key Otto Bock Contact for 
the Study: 
 
Andreas Kannenberg, MD (GER), PhD 
Executive Medical Director North America 
Otto Bock HealthCare LP 
11501 Alterra Parkway,  Suite 600 
Austin, Texas 78758 
Tel. +1-512-806-2605 
andreas.kannenberg@ottobock.com 
 
 
Study Principal 
Investigator: 
 
Danielle Melton, MD 
Assistant Professor 
University of Texas at Houston 
TIRR Memorial Hermann 
 
Original Date of Issue 
(V.1): 
 
 
6 June 2016  
Date(s) of Amendment(s): 
 
V.2 – 26Oct16 
V.3 – 28Nov16 
V.4 – 09May17 
V.5 – 26May17 
 
 
 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation.  It should be held confidential and maintained in 
a secure location.  Do not copy or distribute without written permission from Ottobock HealthCare LP. 
 

 
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Ease Study Protocol P16-01 v. 5 
 
Sponsor Protocol Approval Page 
 
 
StudyTitle: 
 
 
EmPOWERing Active Seniors with Energy  
 
 
 
Product: 
 
The study device is the emPOWER Ankle.  The emPOWER 
Ankle is a powered microprocessor-controlled ankle-foot 
prosthesis. The emPOWER Ankle has been designed and tested to 
ISO 10328 standards. 
 
 
Protocol Version: 
 
 
5.0 
 
Protocol Date: 
 
 
 
 
26 May 2017 
 
Sponsor: 
 
 
 
Otto Bock HealthCare LP 
 
 
 
 
 
 
As the representative of the study sponsor, the undersigned have read and agree to oversee the 
conduct of this study according to the requirements outlined in this study protocol. 
 
 
 
 
_______________________________________________ 
 
__________ 
Andreas Kannenberg, MD, PhD 
 
 
 
 
Date 
Executive Medical Director North America 
Otto Bock HealthCare LP 
                             
              
 
 
 
 
 
 

 
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Ease Study Protocol P16-01 v. 5 
 
Investigator’s Signature Page 
 
STUDY TITLE: 
EmPOWERing Active Seniors with Energy  
 
STUDY SITE: 
_____________________________________________ 
(Print name of study site) 
 
 
Prior to participation in the study as the research center principal investigator (PI), I understand 
that I must obtain written approval from my Institutional Review Board (IRB)/Ethics Committee 
(EC) or the Sponsor will have provided to me a central IRB approval listing me as an 
investigator. This approval must include my name and a copy must be provided to BionX 
Medical Technologies, Inc. or designee along with the approved Informed Consent Form prior 
to the first enrollment of a study subject at my study center.   
 
As the PI, I must also: 
1. 
Conduct the study in accordance with the study protocol, the signed Investigator 
Agreement, and applicable laws and regulations, as well as ensure that all study 
personnel are qualified and appropriately trained prior to any study activities. 
2. 
Ensure that the study is not commenced until all necessary approvals have been obtained. 
3. 
Ensure that a written informed consent is obtained from each subject prior to any data 
collection using the most recent IRB/EC approved subject Informed Consent Form (ICF). 
4. 
Provide all required data and reports, as well as agree to allow source document 
verification of study data with subject’s medical records by a BionX, designee and/or any 
regulatory authorities. 
5. 
Allow BionX personnel or its designees, as well as regulatory representatives, to inspect 
and copy any documents pertaining to this clinical investigation according to the federal, 
state, and institutional data and privacy protection laws.  
 
Investigator Signature  
I have read and understand the contents of the study and agree to abide by the requirements set 
forth in this document.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Name (print) 
 
 
 
Study Center (print) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Signature 
 
 
  
Date 

 
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Protocol Synopsis 
EmPOWERing Active Seniors with Energy 
 
Study 
Population 
The study population will include up to ten (10) unilateral transtibial 
amputees.  
 
Intended Use 
 
The device is intended to replace a missing foot and ankle. The emPOWER 
Ankle is to be used exclusively for fittings of lower-extremity amputations 
as prescribed by a healthcare professional. 
Control 
Subjects serve as their own control with assessments using their prescribed 
passive lower-extremity prosthesis at Baseline and after 2 weeks of re-
accommodation after 3 months of use of emPOWER. 
 
Study Design 
This is a pilot, prospective, cross-over, open label observational study. 
Phase I: Screening through 3 Months 
Phase II: Long-term follow-up of subjects using the emPOWER Ankle in 
their daily lives from 3 Months through 12 Months 
  
Primary 
Objective 
 
 
The primary objective of this study is to characterize the increase in the 
distance subjects can walk during a six (6) minute period while wearing the 
emPOWER Ankle compared to a passive lower-extremity prosthesis. 
Primary 
Effectiveness 
Endpoint 
 
The primary endpoint of this study will be an improvement in walking 
distance with the emPOWER Ankle compared to the distance walked with 
the subject’s passive prosthesis as shown by 6 minute Walk Test (6MWT) 
results at 3 months. 
Secondary  
Endpoints 
 
The secondary endpoints of this study will compare the following 
assessments on the emPOWER Ankle to the subject’s passive prosthesis at 
Baseline (before wearing the emPOWER, when available) and Crossover: 
 
• 12 minute Walk Test (12MWT) 
• 10 meter Walk Test (10MWT) 
• L-Test for overall mobility and fall risk 
• Time and Quality of Ramp Ascent 
• Time and Quality of Ramp Descent 
• Activities-specific Balance Confidence (ABC) Scale  
• Falls Efficacy Scale  
• Amputee Mobility Predictor (AMP) Assessment  
• Prosthetic Limb Users Survey of Mobility (PLUS-M) (12 item Short 
Form)  
• Patient-specific Functional Scale (PSFS) 
• Numeric Pain Rating Scale (NPRS) 
• Activity monitoring over two weeks prior to the assessment session 

 
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with the emPOWER Ankle and the re-assessment session with the 
previous foot using a Fitbit monitor. 
• Falls: Diary of reported falls for two weeks 
• Activity Diary to allow for self-reporting of activities of daily living 
and unique user experiences with the emPOWER Ankle for two 
weeks 
• PROMIS Physical Function (Custom)  
• PROMIS Global Health Short Form 
• PROMIS Fatigue Short Form (7a) 
• PROMIS Pain Intensity Short Form (3a) 
 
Long-term follow-up of subjects who agree to continue wearing the 
emPOWER Ankle at 3, 6 and 12 months with all outcome measures (except 
the activity monitoring and diaries of steps, activity and falls at 6 & 12 
months).  
 
Number of 
Subjects and 
Number of 
Study Sites 
 
Up to ten (10) subjects will be enrolled into this study at one (1) study site.  
Study Duration 
Overall study enrollment is estimated to take two (2) months. The subject’s 
study participation duration will last approximately four (4) months for the 
first phase. If the subject elects to continue in the second phase, that will last 
for an additional 9 months. 
 
Key Inclusion 
Criteria 
I-1. 
Males and females 
I-2. 
55 years or older 
I-3. 
Subjects with transtibial amputations of either leg at least 1-year prior 
I-4. 
Suction or elevated vacuum suspension and Socket Comfort Score of 
at least 6 
I-5. 
Sock fluctuation of ≤ 8 ply per day 
I-6. 
K-level rating of 3 or 4 based on the AMP Assessment Tool 
I-7. 
Ability to walk at a walking speed of > 0.75 meters per second with 
the current prosthesis 
I-8. 
Unilateral amputees (up to 7 bilateral amputees can be included, 1 per 
site in addition to the unilateral amputees who will be analyzed as a 
separate sub group) 
I-9. 
Foot size: 25-30 cm 
I-10. Ability to complete a continuous 6MWT  
I-11. Ability to provide written, informed consent 

 
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I-12. Ability to complete study visits and study documents 
I-13. Ability to manage the complexity of a powered device including 
charging and changing batteries as needed 
I-14. Ability to read and understand English 
 
Key Exclusion 
Criteria 
E-1. Subjects who have never used a prosthetic device 
E-2. Less than 55 years of age 
E-3. Weight <150 lbs. or > 287 lbs. 
E-4. Transfemoral amputees 
E-5. Active sores or ulceration on subject’s residual limb 
E-6. Sore on contralateral foot 
E-7. Cuff-link socket suspension 
E-8. Socket Comfort Score less than 6 
E-9. Sock fluctuation of > 8 per day 
E-10. K level of 1 or 2 
E-11. Amputation clearance < 8.625” 
E-12. History of stroke or TIA that impairs current walking 
E-13. Recent history of excessive falling defined as more than 2 falls 
requiring medical assistance in the prior year 
E-14. Medications potentially affecting balance 
E-15. Recent hospitalization (within past 3 months) 
E-16. Cognitive deficiency that would impact ability to charge and change 
batteries as needed 
 
Primary 
Statistical 
Methods 
 
Subjects will be enrolled to characterize improvements with the emPOWER 
Ankle compared to the subject’s passive prosthesis. Data analysis will be 
descriptive in nature. 
Regulatory 
Status 
 
This study will be conducted in accordance with the Food and Drug 
Administration’s (FDA) regulations1 and guidelines.  The emPOWER ankle-
foot prosthesis is a Class II exempt device in accordance with 21 CFR 
890.3500, which does not require pre-market notification per section 510(k). 
 
1 21 CFR 812.2   
                        

 
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Table of Contents 
Empowering Active Seniors with Energy 
Protocol Synopsis ....................................................................................................................... 4 
Table of Contents........................................................................................................................ 7 
1. 
Introduction ......................................................................................................................... 9 
1.1. Study Rationale ............................................................................................................ 9 
2. 
Device Information ............................................................................................................. 9 
2.1. Principle of Operation .................................................................................................. 9 
2.2. Figure: The emPOWER Ankle ................................................................................... 10 
3. 
Intended Use ...................................................................................................................... 10 
4. 
Primary Objective ............................................................................................................. 10 
5. 
Study Design ..................................................................................................................... 10 
6. 
Study Endpoints ................................................................................................................ 11 
6.1. Primary Endpoint ....................................................................................................... 11 
6.2. Secondary Endpoints .................................................................................................. 11 
7. 
Study Population ............................................................................................................... 11 
7.1. Selection Criteria ........................................................................................................ 11 
Table 7.1.1: Selection Criteria ................................................................................... 11 
7.2. Subject Discontinuation or Withdrawal ..................................................................... 13 
7.3. Subject Enrollment ..................................................................................................... 13 
8. 
Concomitant Medication ................................................................................................... 13 
9. 
Study Visits ....................................................................................................................... 13 
9.1. Screening .................................................................................................................... 13 
9.2. Moment of Enrollment ............................................................................................... 14 
9.3. Subject Identification ................................................................................................. 14 
9.4. Phase I: 1st Visit - Baseline ......................................................................................... 14 
9.5. Phase I: 2nd Visit - Study Procedure ........................................................................... 14 
9.6. Phase I: 3rd Visit - emPOWER Follow Up ................................................................ 15 
9.7. Phase II: 4th Visit – 3 Month Visit .............................................................................. 16 
9.8. Phase II: 5th Visit – Crossover Visit ........................................................................... 16 
9.9. Phase II: 6th Visit – 6 Month Visit .............................................................................. 17 
9.10. Phase II: 7th Visit – 12 Month Visit (Final Study Visit) ............................................. 17 
9.11. Table 9.11.1:  Procedures and Assessments ............................................................... 19 
10. Study Assessments ............................................................................................................ 20 
10.1. Amputee Mobility Predictor (AMP) .......................................................................... 20 
10.2. 12-Minute Walk Test (and 6-Minute Walk Test) (12MWT & 6MWT) .................... 20 
10.3. 10-Meter Walk Test (10MWT) .................................................................................. 20 
10.4. L-Test ......................................................................................................................... 20 
10.5. Ramp Tests (Ascent and Descent) .............................................................................. 21 
10.6. Activities-Specific Balance Confidence (ABC) Scale ............................................... 21 
10.7. Falls Efficacy Scale .................................................................................................... 21 

 
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10.8. Prosthetic Limb Users Survey-M (PLUS-M) ............................................................. 21 
10.9. PROMIS Instruments ................................................................................................. 21 
10.10. 
Patient Specific Functional Scale (PSFS) .......................................................... 22 
10.11. 
Numeric Pain Rating Scale (NPRS) .................................................................. 22 
10.12. 
Activity Monitoring ........................................................................................... 22 
10.13. 
Subject Diary (Activity Monitoring) ................................................................. 22 
11. Statistical Methods ............................................................................................................ 22 
12. Adverse Events .................................................................................................................. 23 
12.1. Adverse Event Relationship Terms ............................................................................ 23 
Table 12.1.1: Definition of event severity for judgment by Investigator. ................. 23 
Table 12.1.2: Definition of serious adverse event, adapted from 21 CFR 803.3. ...... 23 
Table 12.1.3: Definition of event relatedness ............................................................ 24 
12.2. Reporting Requirements ............................................................................................. 24 
Table 12.2.1: Adverse Event Reporting Requirements .............................................. 24 
Table 12.2.2: Sponsor and BionX Reports ................................................................. 25 
12.3. Device deficiencies, Device failures, Malfunctions, and Product Nonconformities .. 25 
12.4. Reporting to Regulatory Authorities /IRBs /ECs /Investigators ................................ 25 
13. Risk Benefit Analysis ........................................................................................................ 25 
13.1. Known and Anticipated Risks .................................................................................... 26 
13.2. Risk Minimization ...................................................................................................... 26 
14. Subject Benefit .................................................................................................................. 26 
15. Ethical Considerations....................................................................................................... 27 
15.1. Study Conduct ............................................................................................................ 27 
15.2. Institutional Review Board ......................................................................................... 27 
15.3. Informed Consent Form ............................................................................................. 27 
15.4. Obtaining Informed Consent ...................................................................................... 27 
15.5. Amending the Protocol ............................................................................................... 28 
15.6. Emergency Actions .................................................................................................... 28 
15.7. Protocol Adherence .................................................................................................... 28 
16. Study Logistics .................................................................................................................. 28 
16.1. Data Management ....................................................................................................... 29 
16.2. Monitoring and Auditing ............................................................................................ 29 
16.3. Device Accountability ................................................................................................ 29 
16.4. Record Retention ........................................................................................................ 29 
16.5. Criteria for Terminating Study ................................................................................... 30 
16.6. Criteria for Suspending/Terminating a Study Center ................................................. 30 
16.7. Insurance .................................................................................................................... 30 
16.8. Publication Policy ....................................................................................................... 30 
17. References ......................................................................................................................... 31 
18. Appendices ........................................................................................................................ 33 
18.1. Abbreviations ............................................................................................................. 33 
18.2. Patient Specific Functional Scale ............................................................................... 33 

 
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1. 
Introduction  
1.1. Study Rationale 
Safety and performance of the emPOWER Ankle has been shown in a laboratory setting.   
 
The primary objective of this study is to show increased mobility and improvement in balance 
and other activities of daily living with the emPOWER Ankle compared to standard carbon fiber 
prosthetic legs, in active seniors to support marketing and reimbursement needs.  
 
2. Device Information 
2.1. Principle of Operation 
The emPOWER Ankle, a Class II exempt device (in accordance with 21 CFR 890.3500, which 
does not require pre-market notification per section 510(k)), represents the first significant 
redesign of the BiOM Ankle. The Ankle is a commercially-available prosthetic device that 
restores ankle power across all walking speeds [1-3].  This emulation is achieved through three 
technologically-novel functionalities. First, the ankle provides late-stance powered assist [2-4].  
Second, the device provides stiffness modulation after heel strike, which decelerates the body 
and thereby reduces impact loads.  Finally, the device is adjusted with personal bionic tuning, in 
which ankle stiffness and power levels are personalized for each user, enabling the user to walk 
within normal biologic ranges [2, 3]. 
 
The ankle optimizes ankle stiffness and power through user-specific settings using a quantitative 
treatment paradigm in which its dynamic response is adjusted to provide biologically-normal 
ankle behaviors [2, 3], removing the subjective and qualitative nature of current prosthetic user 
evaluations and fittings.  As shown in Section 2.2, the emPOWER Ankle was designed with both 
passive and actively powered components in order to emulate biological function throughout the 
gait cycle.  The device continuously modulates ankle stiffness, spring equilibrium and propulsive 
torque throughout a walking gait cycle [2, 5-11].  Computers and sensors that operate biomimetic 
control firmware guide the device’s performance.  The processors are able to adjust the ankle’s 
stiffness, spring equilibria, and propulsive torque 500 times a second.  Similar to the muscle-
tendons and neural reflex control of the human ankle joint, the device is capable of positive 
torque feedback.  An increase in the sensed prosthetic ankle joint torque triggers an increase in 
the torque generated by the actuator, resulting in the automatic modulation of ankle power assist 
with changes in both walking velocity and ground inclination [7,8].  During personal bionic 
tuning, ankle stiffness and the magnitude and timing of power assist are measured directly from 
sensors within the prosthesis and then adjusted to match the performance of a biological ankle.  
Thus, with appropriate tuning of the prosthesis, the walking gait of the user dynamically 
emulates the walking gait of a non-amputee user across the full range of walking velocities [1-3]. 
 
 

 
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2.2. Figure: The emPOWER Ankle 
 
3. Intended Use 
The device is intended to replace a missing foot and ankle.  The emPOWER Ankle is to be used 
exclusively for fittings of lower extremity amputations as prescribed by a healthcare 
professional. 
 
4. Primary Objective 
The primary objective of this study is to characterize the increase in the distance subjects can 
walk during a 6 minute period while wearing the emPOWER Ankle compared to a passive 
lower-extremity prosthesis. 
 
5. Study Design 
This is a pilot, prospective, cross-over, open label observational study. Study subjects will 
remain blinded to the results from their testing and questionnaires from their passive device until 
they have complete the study procedures for the emPOWER. 
 

 
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6. Study Endpoints 
6.1. Primary Endpoint 
The primary endpoint of this study will be an improvement in walking distance with the 
emPOWER Ankle compared to the distance walked with the subject’s passive prosthesis as 
shown by 6MWT results at 3 months. 
 
6.2. Secondary Endpoints 
The secondary endpoints of this study will compare the following assessments on the 
emPOWER Ankle to the subject’s passive prosthesis at Baseline (before wearing the 
emPOWER, when available) and Crossover: 
 
▪ 12 minute Walk Test (12MWT) 
▪ 10 meter Walk Test (10MWT)  
▪ L-Test for overall mobility and fall risk 
▪ Time and Quality of Ramp Ascent   
▪ Time and Quality of Ramp Descent   
▪ Activities-specific Balance Confidence (ABC) Scale 
▪ Falls Efficacy Scale  
▪ Amputee Mobility Predictor (AMP) Assessment  
▪ Prosthetic Limb Users Survey of Mobility (PLUS-M) (12 item Short Form)  
▪ Patient-specific Functional Scale (PSFS)  
▪ Numeric Pain Rating Scale (NPRS) 
▪ Activity monitoring 
▪ Falls  
▪ Activity Diary 
▪ PROMIS Physical Function (Custom)  
▪ PROMIS Global Health Short Form 
▪ PROMIS Fatigue Short Form (7a) 
▪ PROMIS Pain Intensity Short Form (3a) 
 
Long term follow-up of subjects who agree to continue wearing the emPOWER Ankle at 3, 6 
and 12 months with all outcome measures (except the diaries of activity and falls at 6 & 12 
months). 
 
7. Study Population 
7.1. Selection Criteria 
Study inclusion and exclusion criteria for the study are included in Table 7.1.1 below. Prior to 
enrollment in the study, a subject must meet all of the inclusion criteria and none of the exclusion 
criteria.  
 
Table 7.1.1: Selection Criteria 
Selection Criteria 

 
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Selection Criteria 
Inclusion Criteria 
I-1. Male and Female 
I-2. 55 years or older 
I-3. Subjects with transtibial amputations of either leg at least 1-year 
prior 
I-4. Suction or elevated vacuum suspension and Socket Comfort 
Score of at least 6 
I-5. Sock fluctuation of ≤ 8 ply per day 
I-6. K-level rating of 3 or 4 based on the AMP score 
I-7. Ability to walk at a walking speed of > 0.75 meters per second 
with the current prosthesis 
I-8. Unilateral amputees (up to 7 bilateral amputees can be included, 
1 per site in addition to the unilateral amputees) 
I-9. Foot size: 25-30 cm 
I-10. Ability to complete a continuous 6MWT 
I-11. Ability to provide written, informed consent 
I-12. Ability to complete study visits and study documents 
I-13. Ability to manage the complexity of a powered device including 
charging and changing batteries as needed 
I-14. Ability to read and understand English 
 
Exclusion Criteria 
E-1. Subjects who have never used a prosthetic device 
E-2. Less than 55 years of age 
E-3. Weight <150 lbs. or > 287 lbs 
E-4. Transfemoral amputees 
E-5. Active sores or ulceration on subject’s residual limb 
E-6. Sore on contralateral foot 
E-7. Cuff-link socket suspension 
E-8. Socket Comfort Score of less than 6 
E-9. Sock fluctuation of > 8 per day 
E-10. K level of 1 or 2 
E-11. Amputation clearance < 8.625” 
E-12. History of stroke or TIA that impairs current walking 
E-13. Recent history of excessive falling defined as more than 2 falls  
requiring medical assistance in the prior year 

 
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Selection Criteria 
E-14. Medications potentially affecting balance 
E-15. Recent hospitalization (within past 3 months) 
E-16. Cognitive deficiency that would impact ability to charge and 
change batteries as needed 
 
7.2. Subject Discontinuation or Withdrawal 
• Subjects may voluntarily withdraw from the study at any time without reason.  All 
information relative to the withdrawal must be fully documented in the subject’s chart.  
• Subjects withdrawn prior to the study phase where they walk on the emPOWER Ankle will 
be replaced.  
7.3. Subject Enrollment 
The study will enroll up to ten (10) subjects into Phase I. Subjects will then be invited to 
participate in Phase II, long-term follow-up.  The Study Site will be asked to enroll subjects with 
a unilateral transtibial amputation (on either the left or right side).   
 
8. Concomitant Medication  
All current medications will be recorded at study enrollment and any changes during the study 
period will be noted. 
 
9. Study Visits 
This is a pilot, prospective, cross-over, open label observational study that aims to enroll five (5) 
subjects at one (1) study site.  The study will have two (2) study phases:   
Phase I will include all subjects enrolled in the study and followed through emPOWER Follow-
up (Visit 3).     
Subjects who show benefit from the emPOWER Ankle will be offered the opportunity to 
continue to use the emPOWER Ankle after the study and participate in Phase II – Long-term 
follow-up through 12 months.   
The schedule of assessments is shown below in Table 9.11.1, and study assessments are detailed 
in Section 10. 
9.1. Screening 
Subjects presenting to Investigators with transtibial amputations and who are currently using a 
passive prosthetic device will undergo evaluation for potential participation in the study.  
A subject will sign the study-specific informed consent form (ICF) prior to performing any test 
involved in determining eligibility that goes beyond standard of care. 

 
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Each subject must meet the inclusion/exclusion criteria for this study to be eligible for study 
participation.  
9.2. Moment of Enrollment 
Subjects will be considered “enrolled” in the study once compliance with all inclusion and 
exclusion criteria has been verified and documented; and the subject has signed the informed 
consent form.  At that point, the subject will enter the baseline phase of the study. 
9.3. Subject Identification 
Each subject will be assigned a unique subject identification number at the time of consent.  This 
subject identification number will be retained throughout the study if the subject is enrolled.  
Sites will keep a log that notes the subject’s name and corresponding subject identification 
number.  All case report forms (CRFs) will be tracked, evaluated, and stored using only the 
subject ID number and initials.  No personal other identifying information will be included on 
the CRFs. 
 
The ICF will notify subjects that study monitors, auditors, and representatives of government 
agencies will have access to personal identifying information to ensure that data reported on the 
CRFs corresponds to the person who signed the ICF and the information contained in the source 
documentation. 
9.4. Phase I: 1st Visit - Baseline  
For each of the enrolled subjects, characteristics at the time of the procedure including: age, sex, 
weight, amputation side(s) and amputation type(s), medical history will be recorded. At day of 
enrollment, subjects will complete:  
• Amputee Mobility Predictor (AMP) 
• Physical Assessment  
• Fitted with a Fitbit® One™ activity tracker 
o The activity tracker will to be used to monitor steps taken on their passive 
prosthetic device for 14 days.  A minimum of twenty-seven hundred (2700) 
recorded daily steps while using the passive prosthesis will be documented toward 
ability to perform the study’s 6MWT. [12]  
• Subjects will be provided a patient diary to track activity, falls and self-reporting of 
activities of daily living.  
9.5. Phase I: 2nd Visit - Study Procedure  
At the second visit, the subject will complete the following study assessments wearing the 
passive prosthetic:  
 
• 6MWT  
• Ramp Ascent 
• Ramp Descent 
• ABC Scale 
• Falls Efficacy Scale 
• Mobility PLUS-M (12 item Short Form) 
• PROMIS Questionnaires  

 
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At the end of the second visit, subjects will be fitted with the emPOWER Ankle by a qualified 
clinical prosthetist, trained by BionX personnel.  This fitting includes selection of the appropriate 
size and category carbon fiber foot, alignment, and tuning in accordance with the emPOWER 
Instructions For Use (IFU).  The prosthetist will make a determination that the tuning was 
successful (within the bounds specified by the IFU) and the Investigator will maintain a copy of 
the Tuning Record. This initial Tuning Record may also be used to verify that the subject has the 
ability to walk at a self-selected walking speed (SSWS) > 0.75 meters per second with the 
current prosthesis and can walk with variable cadence, where variable cadence is defined as three 
distinguishable walking speeds with a minimum SSWS of 0.75 m/s (one below SSWS, and one 
above SSWS) on the Tuning record.  Distinguishable will be defined as no overlap between the 
three (3) primary step groupings for each walking speed displayed on the Tuning Record. 
 
At fitting of the emPOWER Ankle, the Investigator will instruct the subject to utilize the device 
for a 16-day period of time, within the intended and foreseeable range of use (e.g. – ramps, stairs, 
limited running or jumping, stepping sideways, etc.).  In addition, the investigator will take the 
subject though a series of default operating conditions of the emPOWER Ankle in the clinic 
setting such as with the power turned off. 
  
Each subject will take the emPOWER Ankle (including batteries and charger) home for 16 days 
(to ensure 14 full days of step counts) of use in everyday life situations.  The subject will not be 
under the observation of the Investigator during this take home period.  During the at home 
portion of the study, subjects will continue to monitor daily steps with use of a Fitbit® One™ 
during the time that they are wearing the emPOWER Ankle. Subjects will also maintain an 
Activities of Daily Living Diary during the take home evaluation portion of the study. This Diary 
will allow subjects to note specific activity changes due to the emPOWER Ankle and serve as a 
log for recording any falls. 
 
As a quality check, the steps on the emPOWER Ankle, as recorded in the emPOWER Tuning 
Records, will also be recorded at baseline and at follow-up. 
9.6. Phase I: 3rd Visit - emPOWER Follow Up 
After the 16-day period of use, the subject will return to the prosthetist.   The window for this 
visit is +1 week.   
 
During this visit, the subject will complete the following study assessments wearing the 
emPOWER Ankle:  
• 6MWT 
• Ramp Ascent 
• Ramp Descent 
• AMP 
• ABC Scale 
• Falls Efficacy Scale 
• Mobility PLUS-M (12 item Short Form) 
• PROMIS Questionnaires  

 
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In addition, the patient diary will be reviewed for Fitbit steps, falls and daily activity. 
 
The Investigator will maintain a copy of the Tuning Record. 
9.7. Phase II: 4th Visit – 3 Month Visit 
Subjects will be invited to participate in long-term follow-up.  For a minimum of 14 days prior to 
this visit, the subject should wear the Fitbit and complete the patient diary for steps, fall and 
daily activity. 
 
Subjects will be seen by the prosthetist after wearing the emPOWER Ankle for 3 months.  The 
window for this visit is -1 week / + 6 weeks.   
 
During this visit, the subject will complete the following study assessments wearing the 
emPOWER Ankle:  
• 12MWT (with distance walked assessed at 6 and 12 minutes)  
• 10MWT 
• L-Test 
• Ramp Ascent 
• Ramp Descent 
• ABC Scale 
• Falls Efficacy Scale 
• AMP 
• Mobility PLUS-M (12 item Short Form) 
• PROMIS Questionnaires  
• Patient-specific Functional Scale (PSFS) 
• Numeric Pain Rating Scale (NPRS) 
 
In addition, the patient diary will be reviewed for Fitbit steps, falls and daily activity. 
 
At the end of the study visit, subjects will return to wearing their passive prosthetic foot for 2-4 
weeks of re-accommodation. 
 
The subjects are reminded to wear the Fitbit activity monitor and complete the patient diaries to 
track activity, falls and self-reporting of activities of daily living.  
9.8. Phase II: 5th Visit – Crossover Visit 
Subjects will be seen by the prosthetist after wearing their passive prosthetic foot for 2-4 weeks.  
The window for this visit is 2-6 weeks after passive device fitting.   
 
For a minimum of 14 days prior to this visit, the subject should wear the Fitbit and complete the 
patient diary for steps, falls and daily activity. 
 

 
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During this visit, the subject will complete the following study assessments wearing the passive 
prosthetic:  
• 12MWT (with distance walked assessed at 6 and 12 minutes)  
• 10MWT 
• L-Test 
• Ramp Ascent 
• Ramp Descent 
• ABC Scale 
• Falls Efficacy Scale 
• AMP 
• Mobility PLUS-M (12 item Short Form) 
• PROMIS Questionnaires  
• PSFS 
• NPRS 
 
At the end of the study visit, subjects will return to wearing the emPOWER Ankle for the 
remainder of the study.  If there are any adjustments to the tuning settings different from those 
previously used for the emPOWER Ankle, the tuning record should be saved. 
 
9.9. Phase II: 6th Visit – 6 Month Visit 
Subjects will be seen by the prosthetist.  The window for this visit is -4 weeks / + 3 months.   
 
During this visit, the subject will complete the following study assessments wearing the 
emPOWER Ankle:  
• 12MWT (with distance walked assessed at 6 and 12 minutes)  
• 10MWT 
• L-Test 
• Ramp Ascent 
• Ramp Descent 
• ABC Scale 
• Falls Efficacy Scale 
• AMP 
• Mobility PLUS-M (12 item Short Form) 
• PROMIS Questionnaires  
• PSFS 
• NPRS 
 
If there are any adjustments to the tuning settings for the emPOWER Ankle, the tuning record 
should be saved. 
9.10. Phase II: 7th Visit – 12 Month Visit (Final Study Visit) 
Subjects will be seen by the prosthetist.  The window for this visit is -3 months / + 3 months.  
This will be the final study visit. 
 

 
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During this visit, the subject will complete the following study assessments wearing the 
emPOWER Ankle:  
• 12MWT (with distance walked assessed at 6 and 12 minutes)  
• 10MWT 
• L-Test 
• Ramp Ascent 
• Ramp Descent 
• ABC Scale 
• Falls Efficacy Scale 
• AMP 
• Mobility PLUS-M (12 item Short Form) 
• PROMIS Questionnaires  
• PSFS 
• NPRS 
 
 

 
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9.11. Table 9.11.1:  Procedures and Assessments  
The following table summarizes the timing and specific assessments to be conducted in this 
study: 
 
ASSESSMENT 
BASELINE 
1ST Visit 
PASSIVE 
DEVICE 
ASSESMENT/ 
ANKLE FITTING 
2nd Visit 
emPOWER 
Follow-Up 
3rdVisit 
3 
MONTHS 
4th Visit 
CROSSOVER 
5th Visit 
6 
MONTHS 
6th Visit 
12 
MONTHS 
7h Visit 
Visit Window 
 
 
16 days 
after Visit 2 
+1 week 
-1 week /  
+ 6 weeks 
2-6 weeks after 
passive device 
fitting 
-4 weeks /  
+ 3 months   
-3 months /  
+ 3 months   
Eligibility Assessment 
X 
 
 
 
 
 
 
ICFa 
X 
 
 
 
 
 
 
Demographics  
(DOB, Gender) 
X 
 
 
 
 
 
 
Physical Assessment  
(ht, wt, side and type of 
amputation) 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
AMP 
X 
 
X 
X 
X 
X 
X 
FitBit One™ steps 
+ 
X 
X 
X 
X 
 
 
Tuning Record 
 
X** 
X 
 
*** 
*** 
*** 
6MWT 
 
X 
X 
 
 
 
 
12MWT 
(includes 6 min distance, 
pain-free walking scale and 
BORG RPE) 
 
 
 
X 
X 
X 
X 
10 MWT 
 
 
 
X 
X 
X 
X 
L-Test 
 
 
 
X 
X 
X 
X 
Ramp Test  
(Ascent & Descent) 
 
X 
X 
X 
X 
X 
X 
ABC 
 
X 
X 
X 
X 
X 
X 
Falls Efficacy Scale 
 
X 
X 
X 
X 
X 
X 
PLUS-M 
 
X 
X 
X 
X 
X 
X 
PROMIS Evals 
 
X 
X 
X 
X 
X 
X 
PSFS 
 
 
 
X 
X 
X 
X 
NPRS 
 
 
 
X 
X 
X 
X 
EASE Study Activity 
Diary (Reviewed) 
+ 
X 
X 
X 
X 
 
 
Adverse Events & 
Concomitant 
Medication 
X 
X 
X 
 
X 
X 
X 
 
+ FitBit One™ and diary provided to Subject 
a If the study ICF is modified during the course of the study, study subjects will be re-consented. 
 Confirms walking speeds required for emPOWER Ankle arm 
*** Collect the tuning record if adjustments are made to the emPOWER device 

 
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10.  Study Assessments 
10.1. Amputee Mobility Predictor (AMP) 
The AMP is an instrument designed to measure ambulatory potential of lower-limb amputees 
[13]. Subjects begin the test seated in a hard chair with arms and are tested for a total of 21 items 
assessing abilities of increasing level of difficulty. Abilities assessed include sitting balance, 
transfer from chair to chair, standing balance, gait quality, negotiating obstacles, and the use of 
assistive devices. The total score range for the AMP is 0 to 47 points. A minimal detectable 
change of 3.4 points has been reported [14].  
10.2. 12-Minute Walk Test (and 6-Minute Walk Test) (12MWT & 6MWT) 
The walking test is a validated performance test used to measure gait speed and aerobic 
capacity/endurance. The distance that the patient is able to walk in 6 and 12 minutes is recorded. 
In addition, subjects will be asked to indicate when they experience an onset of pain, if occurring 
during the test, to determine the pain-free walking distance. Assistive devise may be used, but 
should be recorded and consistent between tests. Minimally clinically important differences 
(MCID) have not yet been reported for amputees, but for patients with incomplete spinal cord 
injury (36 m) [15] and stroke (34.4 m) [16]. Generally in rehabilitation, increases in walking 
speed of 0.1 m/s or more, which would equal an increase in walking distance of 36 m or more in 
the 6MWT, are considered clinically meaningful [17-19].  The distance a subject can walk after  
6 and 12 minutes while wearing the emPOWER Ankle compared to the subject’s passive 
prosthesis.  
 
The Borg Rating of Perceived Exertion (RPE) score will also be recorded at 6 and 12 minutes 
and assessment of pain-free walking distance for sound and residual knee and hip, low back pain 
for subjects that report such pain during the 12minWT. The RPE measures the perceived 
intensity of physical activities on a visual analogue scale and provides a good estimate of the 
actual heart rate during physical activity and is correlated with lactate levels, %VO2max, and 
breathing rates in athletes [20]. 
 
10.3. 10-Meter Walk Test (10MWT) 
The walking test is a validated test used to measure gait speed. When available, data will be 
collected for the walking tests. Subjects are often allowed the use of walking aids (such as a 
cane, crutches or hemi-walker) that they normally use in home or community ambulation. In 
addition to the time to complete the test, the use of walking aids, the distance of the walk test and 
the use of footwear (e.g. barefoot or with shoes) will be recorded. 
10.4. L-Test 
The L-Test is a timed 20-meter test of basic mobility skills that includes 2 transfers and 4 turns at 
the subject’s usual walking speed. This test is a modified version of the Timed Up and Go Test 
designed for people with lower limb amputations. The test is measured by the time that it takes a 
subject to stand from an armless chair, walk 10 meters (in the shape of an L) at the subject’s 
usual walking speed, turn 180 degrees, and return 10 meters (in the shape of an L) back to a 
seated position in the same chair [21]. The L-test was selected, since it measures overall 
functional mobility risk and fall and is validated for the amputee population.  The time to 

 
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perform the L-Test with the emPOWER Ankle will be compared to the time on subject’s passive 
prosthesis. 
 
10.5. Ramp Tests (Ascent and Descent) 
The ramp ascent test is a timed performance test of walking up a 25-foot ramp with 5 degree incline 
and an outdoor hill (length and inclination/grade to be determined).   The ramp ascent time with the 
emPOWER Ankle will be compared to the time on the subject’s passive prosthesis followed by the 
Hill Assessment Index.  The Hill Assessment Index is an instrument to measure the quality of the 
subject’s gait during ramp ambulation. 
 
The ramp decent test is a timed performance test of walking down a 25-foot ramp with 5 degree 
incline and an outdoor hill (length and inclination/grade to be determined).  The ramp decent time 
with the emPOWER Ankle will be compared to the time on the subject’s passive prosthesis 
followed by the Hill Assessment Index and questionnaire assessing patient-perceived control of 
walking speed. 
 
10.6. Activities-Specific Balance Confidence (ABC) Scale  
The ABC Scale [22] is a self-administered questionnaire that asks the patient to rate his or her 
confidence in performing various ambulatory activities on a scale from 0% (no confidence) to 
100% (complete confidence) without losing balance or becoming unsteady. Scores for each of 
the 16 items will be collected and an average percentage calculated, with scores <67 indicating 
an increased risk of falling [23]. The scores on the ABC with the emPOWER Ankle will be 
compared to the subject’s passive prosthesis. 
 
10.7. Falls Efficacy Scale 
The Falls Efficacy Scale is a validated 10-item self-report questionnaire designed to assess 
confidence in the ability to perform 10 activities of daily living without falling as an indicator of 
how one's fear of falling impacts physical performance. Each item is rated from 1 ("very 
confident") to 10 ("not confident at all"), and the per item ratings are added to generate a 
summary total score (10 to 100). Lower scores indicate more confidence and higher scores 
indicate lack of confidence and greater fear of falling.  It has been validated for use in the elderly 
[24] and persons with amputations [25]. Scores ≥70 indicate an increased fear of falling. [24, 25] 
 
10.8. Prosthetic Limb Users Survey-M (PLUS-M) 
The PLUS-M is a valid and reliable self-reported measure for the mobility of adults with lower 
limb amputations. PLUS-M asks about the patient’s ability to perform simple and complex tasks. 
This questionnaire is asking about the current timeframe for the patient. High PLUS-M scores 
correspond with greater mobility [26]. The scores on the PLUS-M with the emPOWER Ankle 
will be compared to the scores on the subject’s passive prosthesis. 
 
10.9. PROMIS Instruments 
PROMIS item banks and their short forms are a reliable and precise measurements of patient 
reported outcome measures [27]. For this study, the following instruments will be used: the 
PROMIS Physical Function (Custom), the PROMIS Global Health Short Form, the PROMIS 
Fatigue Short Form (7a), and The PROMIS Pain Intensity Short Form (3a).   The scores on the 

 
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PROMIS instruments with the emPOWER Ankle will be compared to the scores on the subject’s 
passive prosthesis. 
 
10.10. Patient Specific Functional Scale (PSFS) 
The PSFS [28] is a self-report measure aimed at identifying functional status limitations that are 
most relevant to individual patients. The PSFS is a reliable, valid, and efficient measure for 
detecting clinical change in persons with low back pain and knee dysfunction [29]. Patients will 
be asked to identify three to five activities that they are having difficulty or are unable to perform 
because of their injury/condition. For the specified activities, patients will then be asked to rate 
their ability to perform each activity at that time (0-10 numerical scale) with ‘0’ being unable to 
perform the activity, and ‘10’ being able to perform the activity at the same level as they could 
prior to the injury/condition. The scores on the PSFS instruments with the emPOWER Ankle 
will be compared to the scores on the subject’s passive prosthesis. 
  
10.11. Numeric Pain Rating Scale (NPRS) 
The NPRS is a valid and reliable measure of pain that may be used across all musculoskeletal 
injuries/conditions and complements the PSFS [29]. The patient will be asked to rate the pain of 
their joints, foot, lower back, and if they are using an assistive device any additional affected 
limbs on average over the last 24 hours on a scale 1-10, with ‘1’ being ‘very mild’ and ‘10’ being 
the ‘unimaginable unspeakable’. The scores on the NPRS instruments with the emPOWER 
Ankle will be compared to the scores on the subject’s passive prosthesis. 
 
10.12. Activity Monitoring 
An activity monitor will be worn to record the number of steps the patient takes with the 
prosthesis. The patient will return to the site with the activity monitor so that the steps counted 
can be downloaded from the device.  In addition, the patient will be sent home with a prepaid 
envelope and be instructed to mail back the activity monitor if the next visit will be more than 3 
weeks later, to ensure that the data is not lost. The step counts will be downloaded from the 
device the day the activity monitor is returned to the Investigator. The Investigator will record 
the date the patient was affixed with the activity monitor, the date they received the returned 
activity monitor, and the date they synced the monitor. 
10.13. Subject Diary (Activity Monitoring) 
Subjects will be provided with a ‘diary’ to record a daily step-count (using the Fitbit provided), 
falls and daily activity.  Subjects will record positive and negative observations about the 
prosthesis performance while wearing the study devices. These observations will be reviewed 
together with the Investigator during the study visits. In addition, subjects will also record in the 
diary any falls and resulting injuries.  If any of the diary entries reveal complaints or adverse 
events, these will be reported on the Adverse Event form. 
 
11. Statistical Methods 
The study objective is to characterize the improvement in the 6MWT with the emPOWER Ankle 
versus the subject’s passive lower-limb prosthesis. This is calculated as: 
 

 
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Percent change in 6MWT=100 * (emPOWER Ankle 6MWT – Passive Prosthesis 6MWT) / 
Passive Prosthesis 6MWT 
 
A positive value for Percent Change in 6MWT represents the percent increase in the 6MWT, and 
a negative value represents a decrease. 
 
12.  Adverse Events 
12.1. Adverse Event Relationship Terms 
All Adverse Events (AEs) occurring in this study will be reported, including characterization by 
severity, seriousness and relatedness, as described below.  Investigators will record 
characteristics of each adverse event on an Adverse Event CRF.  Each adverse event will be 
judged by the Investigator as to its relationship to the investigational device.  In addition, the 
Investigator will identify the date of onset, severity, seriousness, relatedness and duration of the 
AE.  Severity will be judged using the scale noted in Table 12.1.1: Definition of event severity 
for judgment by Investigator.  Seriousness will be judged using the criteria listed in Table 12.1.2: 
Definition of serious adverse event, adapted from 21 CFR 803.3.  Device relatedness will be 
determined by the criteria listed in Table 12.1.3: Definition of event relatedness. All adverse 
events will be monitored until they are adequately resolved, explained or the subject has exited 
the study.  
  
Table 12.1.1: Definition of event severity for judgment by Investigator. 
Definition of event severity for judgment by Investigator. 
Term 
Definition 
Mild  
Subject is aware of a sign or symptom, but that sign or symptom 
does not interfere with normal activity OR symptom is both 
transient and resolved without treatment 
Moderate Symptoms interfere with the subject’s usual activity OR 
symptoms require treatment 
Severe 
Symptom(s) cause either severe discomfort OR have a significant 
impact of the subject’s usual activity and symptoms require 
treatment 
 
Table 12.1.2: Definition of serious adverse event, adapted from 21 CFR 803.3. 
Definition of serious adverse event, adapted from 21 CFR 803.3. 
An event is considered serious if it: 
(1) Is life-threatening, 
(2) Results in permanent impairment of a body function or permanent 
damage to a body structure, or 
(3) Necessitates medical or surgical intervention to preclude permanent 
impairment of a body function or permanent damage to a body 
structure. 
 
Permanent means irreversible impairment or damage to a body structure or 

 
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function, excluding trivial impairment or damage. 
 
Table 12.1.3: Definition of event relatedness 
Definition of event relatedness 
Term 
Definition 
Definite 
Adverse event whose timing is highly plausible for causality and 
which cannot be explained by other factors 
Probable 
Adverse event whose timing is reasonable for causality and is 
unlikely to be explained by other factors 
Possible 
Adverse event whose timing is reasonable for causality but which 
could be explained by other factors 
Not related 
Adverse event whose timing makes causality improbable and 
which could easily be explained by other factors 
Unknown 
Adverse event whose plausibility of timing cannot be judged or in 
which information regarding other factors does not exist 
 
12.2. Reporting Requirements 
The communication requirements for Adverse Events reporting, from the beginning of  
enrollment through procedure completion, to Ottobock are as follows in Table 12.2.1: Adverse 
Event Reporting Requirements below:  
 
Table 12.2.1: Adverse Event Reporting Requirements 
Adverse Event Reporting Requirements 
Adverse Event 
Classification 
Methods of Communicating 
Events to Ottobock 
Communication 
Timeline to 
Ottobock 
Source Documentation 
Requirements 
SAE and/or 
SADE 
Complete AE CRF with 
all available information. 
 
If CRF is unavailable, 
fax information to the 
Ottobock Clinical Affairs 
Department. 
Within 24 hours 
of first becoming 
aware of the 
event 
Provide copies of all 
relevant source documents 
requested by Ottobock or 
designee as soon as 
possible after reporting the 
event. 
AE/ADE 
Complete AE CRF 
Review with 
Monitor during 
next monitoring 
visit 
No source documents are 
required to be submitted to 
Ottobock. 
 

 
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Table 12.2.2: Sponsor and BionX Reports 
Sponsor and BionX Reports 
Responsible 
Party 
Report 
Submit 
to 
Description 
Sponsor 
SADE, Device-
related AEs 
BionX All SADEs will be sent to BionX Regulatory Affairs 
within 24 hours of first becoming aware of the event 
for review for possible Medical Device Reporting 
(MDR) in accordance with 21 CFR 803.20. All device-
related AEs will be sent to BionX Regulatory Affairs 
department in a monthly report for MDR assessment. 
BionX 
Death or serious 
injury; device 
malfunction 
FDA 
Notification within 5 workdays, 10 workdays or 30 
calendar days after BionX first learns of the event in 
accordance with 21 CFR 803.20, depending on the 
source and action required. 
 
12.3. Device deficiencies, Device failures, Malfunctions, and Product Nonconformities 
All product deficiencies related to the identity, quality, durability, reliability, safety or 
performance of the medical device, failures, malfunctions and product nonconformities will be 
documented on the appropriate CRF and immediately reported to the sponsor (without any delay 
that cannot be justified and within 24 hours of occurrence).  In such cases, the product should 
either be returned to BionX (an Ottobock company, located at 4 Crosby Drive, Bedford, MA  
01730) for analysis or a BionX employee will either inspect or service at the center.  Instructions 
for returning the product will be provided to the centers.  Product failures and malfunctions 
should also be documented in the subject’s medical record. 
 
NOTE: Product failures, malfunctions, and product nonconformities are NOT to be reported as 
adverse events.  However, if there is an adverse event that results from an product failure or 
malfunction, that specific event should be recorded on the AE CRF. 
 
12.4. Reporting to Regulatory Authorities /IRBs /ECs /Investigators 
Ottobock is responsible for reporting adverse event information to all participating investigators 
and regulatory authorities as applicable.  The Site Principal Investigator is responsible for 
informing the IRB of SAEs or other events as required by the overseeing IRB.  A copy of any 
reports to IRBs should be sent to the Ottobock Clinical Operations and BionX Regulatory Affairs 
Department. 
 
13.  Risk Benefit Analysis 
The emPOWER Ankle prosthesis is designed to provide bionic propulsion, emulating the 
biological function of an ankle, and attaches to the wearer by a previously fit socket.  The 
benefits of bionic propulsion for the amputee (as compared to conventional prostheses) have 
been studied and published in peer-reviewed scientific journals, summarized as follows:  
a) walk with a more natural gait; 

 
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b) reduce musculoskeletal stress believed to be causal of osteoarthritis; 
c) use less energy to walk; 
d) walk at a normal preferred speed; 
e) navigate uneven terrain with less effort and greater speed. 
The device’s safety and performance profile has been assessed and has been found to add no 
additional risk to the typical lower-limb prosthetic ankle device. 
 
13.1.  Known and Anticipated Risks  
The emPOWER Ankle is not expected to produce any additional or unique risks as compared to 
those already associated with existing lower-limb prostheses. The anticipated risks are 
summarized as: 
 
1. Trip / Fall Hazard: The risk of trips/falls is inherent to the lower-extremity amputee 
population based on the nature of the condition.  The emPOWER Ankle device, by 
emulating normal biological function of the ankle, is anticipated to exhibit a lower 
incidence of trips/falls than conventional (non-microprocessor) ankle prostheses. 
2. Fire Hazard:  The risk of fire from the Li-ion battery which powers the emPOWER Ankle 
is minimized through design, control circuitry and compliance/testing to international 
standards. 
3. Electrocution Hazard:  The battery-powered ankle prosthetic itself does not present a risk 
of electrocution, however the AC-powered battery charger presents the same risk of 
electrocution as other 120V AC powered devices. 
 
13.2.  Risk Minimization  
The Sponsor will employ measures throughout the course of this study to minimize risks to 
subjects choosing to participate.  All efforts will be made to minimize potential risks by: 
 
1. Selecting Principal Investigators who are experienced and skilled in fitting and aligning 
lower limb prostheses. 
2. Providing training on the equipment prior to use 
3. Defining inclusion/exclusion criteria clearly to ensure only appropriate subjects are 
enrolled.  
4. Ensuring that the treatment of the subject is consistent with current medical practices. 
 
14.  Subject Benefit 
Subjects who demonstrate improvements using the emPOWER Ankle compared to their passive 
prosthetic device will be offered the opportunity to continue using the emPOWER Ankle at the 
end of the study until there is Medicare payment available for the subject to purchase a 
emPOWER Ankle. The subject will not be told of this prior to study completion to avoid bias.  
All subjects will receive fair compensation for completion of the study to cover costs of travel to 
and from the study center and for any potential lost wages due to the study visits. 
 

 
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15.  Ethical Considerations 
15.1. Study Conduct 
The Investigator will conduct the study within the regulations and guidelines of the Food and 
Drug Administration (FDA) and all country/state/local regulations, whichever affords the 
greater protection to the subject. 
 
15.2. Institutional Review Board 
A copy of the protocol, proposed ICF, other written subject information and any proposed 
subject recruitment material must be submitted to the IRB for written approval prior to use.  A 
copy of the written IRB approval of both the protocol and ICF, as well as the IRB’s concurrence 
with the justification for non-significant risk status, must be received by Ottobock before 
recruitment of subjects into the study and shipment of product. 
 
The Investigator must submit and, where necessary, obtain approval from the IRB for all 
subsequent protocol amendments and changes to the Informed Consent form. The Investigator 
must notify the IRB of deviations from the protocol and SAEs occurring at the site and other 
SAE reports received from Ottobock in accordance with the overseeing IRB’s requirements. 
 
The Investigator is responsible for obtaining annual IRB approval and renewal throughout the 
duration of the study.  Copies of the Investigator’s reports and the IRB continuance of approval 
must be sent to Ottobock.  
 
15.3. Informed Consent Form 
Ottobock will provide a sample ICF to the Investigator to prepare for use at his/her site. The 
written Informed Consent documents should be prepared in the language(s) of the potential 
subject population. 
 
Ottobock and the reviewing IRB must approve the ICF before use at that center.  The ICF(s) 
must be in agreement with the 21 CFR Part 50.  
 
15.4. Obtaining Informed Consent 
The background of the proposed study and the benefits and risks of the procedures and study 
must be explained to the subject.  The subject must sign the consent form prior to enrollment.  
This form or a modification based on IRB recommendations must be presented to and signed by 
all enrolled subjects and signed by the principal investigator or designee. 
 
Prior to obtaining informed consent, information should be given in a language and at a level of 
complexity understandable to the subject in both oral and written form by the investigator or 
assigned designee.  Subjects should not be coerced, persuaded, or unduly influenced to 
participate or remain in the study.  A subject or his/her legal representative must be given ample 
time and opportunity to inquire about details of the study and all questions about the study 
should be answered to the satisfaction of the subject or the representative.   
 

 
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Prior to participation in the study, the written informed consent form should be signed and 
personally dated by the subject or his/her legal representative, and by the person who conducted 
the informed consent discussion (investigator or designee).  If the subject or his/her legal 
representative is unable to read the consent form, a witness will need to be present during the 
entire informed consent discussion.  After the informed consent form is read to the subject and 
signed by the subject or his/her legal representative, the witness should also sign the consent 
form, attesting that informed consent was freely given by the subject. The informed consent 
process should be documented in each subject’s record. 
   
The subject or his/her legal representative must receive a copy of the signed and dated informed 
consent form. 
 
The consent form should be updated or amended whenever new information becomes available 
that may be relevant to the subject. 
 
Subjects will be informed that the sponsor and regulatory authorities will have access to personally 
identifying information for the purposes of monitoring data against source documentation.  However, all 
data stored and presented by the sponsor will be in anonymous form. 
 
15.5. Amending the Protocol 
This protocol must be followed exactly, and can be altered only by written amendments by the 
study sponsor.   
 
15.6. Emergency Actions 
Ottobock accepts the right of the Investigator to deviate from the protocol only in an emergency 
when necessary to safeguard the life or the physical well-being of a study subject.  The 
Investigator must give notice of any emergency deviations and justification for the deviation to 
Ottobock and the IRB as quickly as possible after the episode, but in any event no later than 24 
hours after the emergency. 
 
15.7. Protocol Adherence 
Prior to beginning the study, the Investigator must sign the Investigator Agreement and Protocol 
Signature page documenting his/her agreement to conduct the study in accordance with  
the protocol.  An Investigator must not make any changes or deviate from this protocol, except to 
protect the life and physical well-being of a subject in an emergency.  Each deviation from the 
protocol must be documented with the date and reason for the deviation and reported to Ottobock 
and to the IRB, per local guidelines and government regulations.   
 
16.  Study Logistics 
Ottobock and BionX will make necessary efforts to ensure that this study is conducted in 
compliance with Good Clinical Practices and all applicable regulatory requirements. 
 

 
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All personnel to participate in the conduct of this clinical study will be qualified by training, 
education and/or experience to perform his or her respective tasks.     
 
16.1.  Data Management 
Subject data will be collected on case report forms (CRFs).  The Principal Investigator or Sub-
investigator must ensure the accuracy and completeness of the recorded data. Changes to data 
previously submitted to the sponsor will require the Investigator to acknowledge/approve the 
changes in writing. 
 
Visual and/or computer data review will be performed to identify possible data discrepancies.  
queries will be created and will be issued to the center for appropriate response.  The site staff 
will be responsible for resolving all queries. 
 
Data from all study subjects through point of study completion or study withdrawal will be 
reported. 
 
16.2. Monitoring and Auditing 
Monitoring visits to the centers will be made periodically during the study, to ensure that all 
aspects of the current, approved protocol/amendment(s) are followed.  Original source 
documents will be reviewed for verification of data.  The Investigator/institution guarantees 
direct access to original source documents by Ottobock personnel, their designees, and 
appropriate regulatory authorities.  In the event that the original medical records cannot be 
obtained for a subject that is seen by a non-study physician at a non-study institution, 
photocopies of the original source documents must be made available for review. 
 
The study may also be subject to a quality assurance audit by Ottobock and/or BionX or its 
designees, as well as inspection by appropriate regulatory authorities. 
 
It is important that the Investigator and relevant study personnel are available during the 
monitoring visits and audits and that sufficient time is devoted to the process. 
 
16.3. Device Accountability 
Device accountability records must be maintained at each center.  The quantity of devices 
received by each center, those returned to the supplier, and those devices used at the center will 
be recorded in the device accountability record.  The Investigator must explain in writing the 
reasons for any discrepancy noted in device accountability.  The centers will return any 
emPOWER product unwanted by subjects back to BionX.  BionX will provide instructions to the 
centers on the proper method to return the used product. 
 
16.4. Record Retention 
The Investigator will maintain all essential study documents and source documentation, in 
original format, that support the data collected on the study subjects.  Documents must be 
retained for at least 2 years after clearance of the marketing application or until at least 2 years 

 
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have elapsed since the formal discontinuation of the clinical investigation of the product, 
whichever is later.  When these documents no longer need to be maintained, it is Ottobock’s 
responsibility to inform the Investigator.  The Investigator will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed.  If for any reason the 
Investigator withdraws responsibility for maintaining these essential documents, custody must be 
transferred to an individual who will assume responsibility.  Ottobock must receive written 
notification of this custodial change.  
 
16.5. Criteria for Terminating Study 
Ottobock reserves the right to terminate the study but intends only to exercise this right for valid 
scientific or administrative reasons and reasons related to protection of subjects.  Investigators 
and associated IRBs will be notified in writing in the event of termination. 
 
16.6. Criteria for Suspending/Terminating a Study Center 
Otto Bock HealthCare LP reserves the right to either suspend or terminate enrollment at a study 
center at any time after the study initiation if no subjects have been enrolled, if the center has 
multiple or severe protocol deviations or violations without justification or fails to follow 
remedial actions. 
 
16.7. Insurance 
If subjects are injured due to their participation in this study, their physician will provide medical 
care to treat their injury.  Otto Bock HealthCare LPwill maintain appropriate liability insurance 
coverage as required under applicable laws and regulations and will comply with applicable local 
law and custom concerning specific insurance coverage.  If required, a Clinical Study insurance 
statement/certificate will be provided to the IRB.   
 
16.8.  Publication Policy 
At the conclusion of the study, the aggregate clinical study data may be submitted for publication 
in a peer- reviewed journal.  The order of authorship will be according to the number of subjects 
enrolled at the site, as well as the level of contribution to the final manuscript.  In the event that 
more investigators participate than allowed by the journal, all Principal investigators will be 
listed according to the enrollment and sub-investigators will be acknowledged in an 
acknowledgements section.   
 
This clinical study will be registered on clinicaltrials.gov.  
 
 
 

 
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17. References 
1. A. Grabowski, S. D’Andrea, H. Herr. “Bionic leg prosthesis emulates biological ankle 
joint during walking,” Amer. Society of Biomechanics, 2011. 
2. H. Herr, A. Grabowski. “Bionic ankle–foot prosthesis normalizes walking gait for 
persons with leg amputation,” Proceeding of the Royal society B, 2011. 
 
3. A.M. Grabowski, S. D’Andrea. “Effects of a powered ankle-foot prosthesis on kinetic 
loading of the unaffected leg during level-ground walking,” Journal of NeuroEngineering 
and Rehabilitation 10: 49, 2013. 
4. J. Aldridge, J. Sturdy, J. Wilken. “Stair ascent kinematics and kinetics with a powered 
lower leg system following transtibial amputation,” Gait & Posture 36 291–295, 2012. 
5. S. Au, J. Weber, E. Martinez-Villapando, H. Herr. “Powered Ankle-Foot Prosthesis for 
the Improvement of Amputee Ambulation,” IEEE Engineering in Medicine and Biology 
International Conference. Lyon, France, pp. 3020-3026, 2007. 
6. Au S., Herr H. “On the Design of a Powered Ankle-Foot Prosthesis: The Importance of 
Series and Parallel Motor Elasticity,” Special Issue of the IEEE Robotics & Automation  
Society IEEE Magazine on Adaptable Compliance for Robotic Applications. September 
2008; 52-59. 
7. M. Eilenberg, H. Geyer, H. Herr. “Control of a powered ankle-foot prosthesis based on a 
neuromuscular model,” Neural Systems and Rehabilitation Engineering, IEEE 
Transactions on 18, 164-173, 2010.  
8. J. Markowitz, P. Krishnaswamy, M. Eilenberg, K. Endo, C. Barnhart, H. Herr. “Speed 
adaptation in a powered transtibial prosthesis controlled with a neuromuscular model,” 
Theme Issue of Philosophical Transactions B 366, 2011. 
9. Au S., Weber J., Herr H. “Powered Ankle-foot Prosthesis Improves Walking Metabolic 
Economy,” IEEE Transactions on Robotics. 2009; 25 (1): 51-66. 
10. H. Herr, A. Grabowski “Powered ankle-foot prosthesis improves metabolic demand of 
unilateral transtibial amputees during walking,” Amer. Society of Biomechanics, 2010. 
11. A Grabowski, H Herr “Bionic leg prosthesis normalizes the metabolic cost of walking,” 
Rocky Mountain Regional Amer. Society of Biomechanics, 2011. 
12. Arch ES, Ero 0, Bortz C, et al. A method to quantify cadence variability of individuals 
with lower limb amputation. J. Rehabil Res Dev, In Press. 
13. Gailey, R. S., Roach, K. E., Applegate, E. B., Cho, B., Cunniffe, B., Licht, S., ... & Nash, 
M. S. (2002). The amputee mobility predictor: an instrument to assess determinants of the 
lower-limb amputee's ability to ambulate. Archives of physical medicine and 
rehabilitation, 83(5), 613-627. 
14. Resnik L, Borgia M. (2011). Reliability of outcome measures for people with lower-limb 
amputations: Distinguishing true change from statistical error. Phys Ther, 91(4):555-565. 
15. Forrest GF, Hutchinson K, Lorenz DJ, et al. (2014). Are the 10 Meter and 6 Minute Walk 
Tests Redundant in Patients with Spinal Cord Injury?PLoS ONE. 9(5):e94108. 
16. Eng JJ, Dawson, AS. (2004). Submaximal exercise in persons with stroke: test-retest 
reliability and concurrent validity with maximal oxygen 
consumption. ArchPhysMedRehabil, 85(1): 113-118. 
17. Perry J, Garrett M, Gronley JK, Mulroy SJ. (1995). Classification of walking handicap in 
the stroke population. Stroke,26(6):982-989. 

 
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18. Perrera S, Mody SH, Woodman RC, Studenski SA. (2006). Meaningful change and 
responsiveness in common physical performance measures in older adults. J Am Geriatr 
Sco, 65(5):743-748. 
19. Schmid A, Duncan PW, Studenski S, Lai SM, Richards L, Perera S, Wu SS. (2007). 
Improvements in speed-based gait classifications are meaningful. Stroke, 38(7):2096-
2100. 
20. Borg G. (1983). A category-ratio perceived exertion scale: relationship to blood and 
muscle lactates and heart rate. Med. Sci. Sports Exerc, 15(6):523-528. 
21. Deathe, A. B., & Miller, W. C. (2005). The L test of functional mobility: measurement 
properties of a modified version of the timed" up & go" test designed for people with 
lower-limb amputations. Physical therapy, 85(7), 626. 
22. Lajoie Y, Gallagher SP. (2004). Predicting falls within the elderly community: 
comparison of postural sway, reaction time, the Berg balance scale and ABC scale for 
comparing fallers and non-fallers. Arch Gerontol Geriatr, 38(1): 11-26. 
23. Miller WC, Deathe AB, Speechley M. (2003). Psychometric properties of the Activities-
specific Balance Confidence Scale among individuals with a lower-limb 
amputation. Arch Phys Med Rehabil, 84(5):656-661. 
24. Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and 
initial validation of the Falls Efficacy Scale International (FES-I). Age Ageing 2005; 
34(6):614-619. 
25. Miller WC, Deathe AB, Speechley M, Koval J. The influence of falling, fear of falling, 
and balance confidence on prosthetic mobility and social activitity among individuals 
with a lower extremity amputation. Arch Phys Med Rehabil 2001;82(8):1238-1244. 
26. Hafner BJ, Gaunaurd IA, Morgan SJ, Amtmann D, Salem R, Gailey RS. (2016). 
Construct validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in adults 
with lower limb amputation. Arch Phys Med Rehabil . pii: S0003-9993(16)30902-9. doi: 
10.1016/j.apmr.2016.07.026. [Epub ahead of print]  
27. Cella, D., et. all. (2005-2008) Initial item banks and first wave testing of the Patient-
Reported Outcomes Measurement Information System (PROMIS) network. Journal of 
Clinical Epidemiology. 63(11), 1179-94 
28. Stratford, P., Gill.C. et all (1995). Assessing disability and change on individual patients: 
A report of a patient specific measure. Physiotherapy Canada. 47(4):258-262. 
29. Chatman, A., Hyams, S., Neel, J., Binkley, J., Stratford, P., Schomberg, A., Stabler, M. 
(1997). The patient-specific functional scale: measurement properties in patients with 
knee dysfunction. Phys Ther. 77:820-9. 

 
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18.  Appendices 
18.1. Abbreviations 
6MWT 
Six-Minute Walk Test 
10MWT 
10 Meter Walk Test 
12MWT 
12-Minute Walk Test 
ABC 
Activities-specific Balance Confidence 
AE 
Adverse Event 
ADA 
Americans With Disabilities Act 
ADE 
Adverse Device Effect 
AK 
Above Knee 
AMP 
Amputee Mobility Predictor (Score or Assessment Tool) 
BK 
Below Knee 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
EASE 
Empowering Active Seniors with Energy  
EC 
Ethics Committees  
FDA 
Food and Drug Administration 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
MCID 
Minimally clinically important differences 
NPRS 
Numeric Pain Rating Scale 
PSFS 
. Patient Specific Functional Scale 
PI 
Principal Investigator 
PLUS-M 
Prosthetic Limb Users Survey of Mobility PLUS-M (12 item Short Form) 
PROMIS 
Patient Reported Outcomes Measurement Information System 
RPE 
Borg Rating of Perceived Exertion 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SSWS 
Self-Selected Walking Speed