Clinical trial NCT02958553: EmPOWERing Active Seniors With Energy
Official title: EmPOWERing Active Seniors With Energy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: Lower Extremity Limb Loss
Prosthesis Use
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
Collaborators: name: BionX Medical Technologies, Inc.
First posted: 2016-11-08
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First the patient data is gathered with the subject's own passive prosthetic. Then switched over to the emPOWER Ankle. Third, the patient's prosthetic is switched back to test for carry-over benefits. Then they are put on the emPOWER for a final series of tests.
Primary purpose: TREATMENT

Brief summary: A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males and females
* 55 years or older
* Subjects with transtibial amputations of either leg at least 1 year prior
* Suction or elevated vacuum suspension and Socket Comfort Score of at least 6
* Sock fluctuation of ≤ 8 ply per day
* K-level rating of 3 or 4 based on the Amputee Mobility Predictor Assessment Tool
* Ability to walk at a walking speed of \> 0.75 meters per second
* 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)
* Foot size: 25-30 cm
* Ability to complete a continuous 6-Minute Walk Test
* Ability to provide written, informed consent
* Ability to complete study visits and study documents
* Ability to manage the complexity of a powered device including charging and changing batteries as needed
* Ability to read and understand English

Exclusion Criteria:

* Subjects who have never used a prosthetic device
* Less than 55 years of age
* Weight \<150 lbs. or \> 287 lbs.
* Transfemoral amputees
* Active sores or ulceration on subject's residual limb
* Sore on contralateral foot.
* Cuff-link socket suspension
* Socket Comfort Score less than 6
* Sock fluctuation of \> 8 per day
* K level of 1 or 2
* Amputation clearance \< 8.625"
* History of stroke or TIA that impairs current walking
* Recent history of excessive falling defined as more than 2 falls requiring medical assistance in the prior year
* Medications potentially affecting balance
* Recent hospitalization (within past 3 months)
* Cognitive deficiency that would impact ability to charge and change batteries as needed

Primary outcomes:
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)
timeFrame: 3 months with the emPOWER ankle
Secondary outcomes:
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a)
timeFrame: 3 months with the emPOWER ankle
measure: Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a)
timeFrame: 3 months with the emPOWER ankle
Other outcomes:
measure: Activity Diary
timeFrame: 3 months
Locations:
city: Houston
country: United States
facility: UTHealth, Department of Orthopedic Surgery
state: Texas
Study officials:
affiliation: Principal Investigator
name: Danielle Melton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: