N/A
N=52
Home Study of an Advanced Upper Limb Prosthesis
Traumatic Amputation of Arm
Bottom Line
View on ClinicalTrials.gov: NCT01551420 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change in Quality of Life (QOL) Scale — 5.8; 5.3 score on a scale — p=.9358
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Advanced upper limb prosthetic device IMU controlled (Device); Advanced upper limb prosthetic EMG-PR controlled (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life (QOL) Scale |
5.8; 5.3 | .9358 |
| SECONDARY Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale |
0.3; 0.4; 0.7; 0.6; 0.6; 0.1 | <0.0001 sig |
| SECONDARY Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale |
3.6; 3.7; 3.5; 3.0; 3.8; 2.7 | 0.186 |
| SECONDARY Activities Measure for Upper Limb Amputees (AM-ULA) |
17.5; 10.4; 16.8; 16.8; 10.7; 19.8 | 0.3367 |
| SECONDARY Three Scales of the Veterans Version of the SF-36 |
80.0; 74.5; 77.8; 71.3; 82.2; 72.3 | 0.5465 |
| SECONDARY Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests |
0.37; 0.37; 0.35; 0.39; 0.45; 0.42 | 0.6691 |
| SECONDARY University of New Brunswick Test of Prosthetic Function (UNB) |
3.1; 3.2; 3.0; 3.1; 3.2; 3.4 | 0.6529 |
| SECONDARY Timed Measure of Activity Performance (T-MAP) |
459.8; 366.5; 748.1; 549.0; 624.8; 443.3 | <0.0001 sig |
| SECONDARY Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) |
42.4; 37.6; 44.3; 45.8; 38.0; 41.5 | 0.0465 sig |
| SECONDARY The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) |
53.8; 53.1; 54.4; 52.4; 58.1; 51.3 | 0.6881 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01551420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.