Home Study of an Advanced Upper Limb Prosthesis

Study Overview
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Brief Summary
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The overall study objective is to examine the feasibility, acceptance, and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage. All participating subjects will enroll in Part A of the study which will involve supervised training. Eligible subjects will be invited to participate in Part B, the home use portion of the study.

Detailed Description
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The specific objectives of this study are to: identify and describe upper limb amputees who would be appropriate candidates for home use of this advanced prosthesis as well as those who would not be appropriate. Compare the extent of use of the existing prosthesis to that of the DEKA Arm.and quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities and the user's quality of life. Compare the outcomes of users of pattern recognition to the outcomes of users without quantify the amount and type of technical support and repairs needed during the study, and estimate the number of home study days lost due to service/repair. All participating subjects will enroll in Part A of the study, which will involve supervised, in-laboratory training, as well as supervised community based outings. Based upon the findings from Part A, study staff will classify participants as appropriate or not appropriate for participation in Part B (the home usage portion of the study). Final determination of appropriateness for home use will be made after a home visit. The home use portion of the study will last for 13 weeks and involve regularly scheduled study visits. Measures of existing prosthetic activity will be compared with those of home use of the advanced upper limb prosthetic device to determine the extent of adoption. Changes in device satisfaction, performance of functional activities, and quality of life will be evaluated throughout the study. Data on technical support usage will also be gathered.

Official Title
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Home Study of an Advanced Upper Limb Prosthesis

Conditions
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Traumatic Amputation of Arm

Intervention / Treatment
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* Device: Advanced upper limb prosthetic device IMU controlled
* Device: Advanced upper limb prosthetic EMG-PR controlled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria (Parts A and B): All subjects must be at least 18 years old and have single or bilateral upper limb amputation. Subjects must be able to understand the requirements of the study and sign an Informed Consent Form and HIPAA Authorization Form. Subjects will include those who are current users of any type of prosthetic device (body powered, electric or hybrid), non-users of devices who have been previously fit with a device, but have chosen not to wear it, as well as new users of devices. To participate in the study all subjects must have active control over one or both ankles, OR have an appropriate number of myoelectric and/or other control sites (as determined by the Principal Investigator in conjunction with the research team) to allow adequate prosthetic controls configuration. Inclusion Criteria Part B only: Completion of all Part A study activities. Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use. Exclusion Criteria: Exclusion Criteria (Parts A and B): Amputees with elbow disarticulation, wrist disarticulation and partial hand amputations will be excluded. *beginning July 1, 2016 amputees with shoulder disarticulation or forequarter amputation will be excluded. Amputees will be excluded if the length of their residual limb would prohibit socket fitting, as determined by the study prosthetist. Persons with significant uncorrectable visual deficits that would impair the ability to see the prosthesis and those who have major communication or neurocognitive deficits will be excluded. Persons with skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevented prior prosthetic wear will be excluded. Persons with electrically controlled medical devices including pacemakers, and implanted defibrillators will be excluded. Persons with neuropathy, uncontrolled diabetes, who are receiving dialysis, have insensate feet, severe phantom pain or a history of skin ulcers or any other significant comorbidity which would interfere with the study will be excluded. Those with severe circulatory problems including peripheral vascular disease and pitting edema will be excluded. Persons with cognitive deficits or mental health problems that would limit their ability to participate fully in the study protocol will be excluded. Women who are pregnant or who plan to become pregnant in the near future will also be excluded. The investigators will exclude those amputees who work for prosthetic companies that may be considered competitors for the prosthetic arm technology in the future. Persons taking medication which poses a risk for operation of heavy equipment will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sequential testing in non-equivalent comparison groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advanced upper limb prosthetic device IMU controlled<br>Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls | Device: Advanced upper limb prosthetic device IMU controlled<br>* Advanced upper limb prosthetic IMU controlled<br>* Other names: DEKA Arm, DARPA Arm IMU controlled;|
| Active Comparator: Advanced upper limb prosthetic EMG-PR controlled<br>Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls | Device: Advanced upper limb prosthetic EMG-PR controlled<br>* Advanced upper limb prosthetic EMG-PR controlled<br>* Other names: DEKA Arm, DARPA Arm EMG-PR controlled;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life (QOL) Scale | The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B. | baseline and after 9-12 weeks of home use (end of Part B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) | The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: selfcare, instrumental, and daily living tasks using a 5-point scale from 1=Very Easy to 5=Cannot perform. Total score was calculated using IRT methods and ranged from 0 to 100 with lower scores reflecting better function. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) | The CRIS measures community reintegration. It consists of three scales extent and frequency, perceived limitations, and satisfaction. Higher scores (range 0-100) indicate better community integration. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale | Measures the engagement of the prosthesis in everyday activities using 23 items from the OPUS UEFS. Respondents indicate which activities they performed using a prosthesis. The score is the proportion of activities performed using a prosthesis. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale | The TAPES Satisfaction scale is a 10-item scale measuring extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated from 1-5 (1=Very Dissatisfied to 5=Very Satisfied). The average score is used. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| Activities Measure for Upper Limb Amputees (AM-ULA) | The AM-ULA is an 18-item measure assessing functional performance with a prosthesis: ability of the amputee to complete daily activities, speed of the performance, movement quality, skillfulness of prosthetic use and independence. Items are rated 0=Unable to perform task to 4=Excellent Performance. Average score is multiplied by 10 and has a range from 0 (lowest functional performance) to 40 (highest functional performance). | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| Three Scales of the Veterans Version of the SF-36 | Role Physical: measures role physical function with 4 items referring to role limitations due to physical health. Items are rated from 1=none of the time to 5=All of the time. Social Functioning: measures social functioning with 2 items referring to problems interfering with socializing with friends and family. One item is rated extent of problems as 1=Not at all to 5=Extremely and is reverse coded. All other items are rated as problem frequency from 1=All of the time to 5=None of the time. The mean score is scaled to range between 0 to 100. Physical Functioning: measures physical functioning with 10 items pertaining to moving, lifting and walking. Items are rated from 1=Limited a lot to 3=Not limited at all. The mean score is scaled to range between 0 to 100. In all scales, higher scores correspond to higher quality of life. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests | JTHFT Writing: Evaluates the time needed to print a 24-letter, third-grade reading difficulty sentence. JTHFT Page turning: Evaluates the time needed to turn over 7.6 x 12.7 cm (3x5) cards in simulated page turning. JTHFT Small objects: Evaluates the time needed to perform pick up small common objects including pennies, paper clips, bottle caps and placing them in a container. JTHFT Stacking checkers: Evaluates the time needed to stack four checkers. JTHFT Simulated feeding: Evaluates the time needed to perform simulated feeding. JTHFT Moving large empty cans: Evaluates the time needed to move large empty cans. JTHFT Moving large 1 lb. cans: Evaluates the time needed to move 1 lb. cans. All subtests are modified to cap the maximal time for the subtask at 120 seconds and is scored as the number of items completed per second. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| University of New Brunswick Test of Prosthetic Function (UNB) | This test is performed with unilateral amputees only. The subtest used includes wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush. Each task was rated for both spontaneity and skill. UNB Spontaneity: Spontaneity rates spontaneity of prosthesis use (0=prosthesis not used to 4=immediate, consistent use of terminal device. UNB Skill: rates skill of performing the activities (0 = prothesis not used to 4 = active terminal device is quick & smooth). Summary scores are calculated for each subscale by averaging items and range from 0 to 4 with higher scores reflecting higher spontaneity and skill. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 
| Timed Measure of Activity Performance (T-MAP) | The T-MAP is a performance measure of daily activities for persons with upper limb amputation utilizing 5 every day activities. Time (seconds) to completion of activity is measured and summed to obtain overall timed score. Lower overall scores (less time taken) indicate better / faster activity performance | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Prosthetic Design, Upper Extremity