Home Study of an Advanced Upper Limb Prosthesis

VA Office of Research and Development52 enrolled

Overview

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.

The specific objectives of this study are to: 1. 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. 2. 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. 3. Compare the outcomes of users of pattern recognition to the outcomes of users without 4. 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Amputation of Arm

Interventions

Advanced upper limb prosthetic device IMU controlledDEVICE

Advanced upper limb prosthetic IMU controlled

Advanced upper limb prosthetic EMG-PR controlledDEVICE

Advanced upper limb prosthetic EMG-PR controlled

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Center for the Intrepid/ Brooke Army Medical Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and after 9-12 weeks of home use (end of Part B)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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