ClinicalTrials.gov identifier: NCT01551420
Purpose: 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.
Study type: Observational
Study design: Cohort, perspective
Estimated Enrollment: 100
Eligibility criteria: Both genders eligible; ages 18 years and older. Patients must have single or bilateral upper limb amputation and must be able to understand the requirements of the study and sign an informed consent form and HIPAA authorization form. Patients must either be current users of any type of prosthesis or non-users of devices who have been previously fit for a device, but chosen not to wear it. Patients must have active control over one or both ankles or an appropriate number of myoelectric and/or other control sites to allow adequate prosthetic controls configuration. Excludes patients with elbow disarticulation, wrist disarticulation, partial hand amputation, shoulder disarticulation or forequarter amputation; with a residual limb of length that prohibits socket fitting; with significant uncorrectable visual deficits; with skin conditions, such as burns or poor skin coverage, as well as those with severe contractures that prevented prior prosthetic wear; with electrically controlled medical devices, including pacemakers and implanted defibrillators; 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; with severe circulatory problems, including peripheral vascular disease and pitting edema; with cognitive deficits or mental health problems that would limit their ability to participate fully in the study protocol; who are pregnant or plan to become pregnant; who work for prosthetic companies that may be considered competitors for the prosthetic arm technology in the future; or who are taking medication which poses a risk for operation of heavy equipment.
Study start date: April 2012
Estimated study completion date: February 2018
Estimated primary completion date: The final collection date for primary outcome measures will be December 2017.
Primary outcome measures: Change in quality of life (QoL) scale at baseline and after 13 weeks of home use. The QOL scale includes 16 questions that assess satisfaction with independent living and self-care activities.
Secondary outcome measures: Home use appropriateness, measured for up to 6 weeks of in-lab use; extent of prosthetic use, measured 2 weeks prior to in-lab training and daily throughout home usage portion of the study; daily logs detailing use of current prostheses and the advanced prosthetic device, Trinity Amputations and Prosthetics Experience Scale; Activities Measure for Upper Limb Amputees; SF-36 V, Wong-Baker FACES Pain Rating Scale; Upper Extremity Functional Scale; Patient-Specific Functional Scale; and the Community Reintegration of Service Members Computer Adaptive Test, all measured at baseline, visit 14, for up to 6 weeks of in-lab use, biweekly throughout home usage portion of the study and after 13 weeks of home use; and neuropsychological testing battery, Jebsen-Taylor Hand Function Test, University of New Brunswick Test of Prosthetic Function and Adapted Rivermead Extended Activities Index, all measured at baseline, visit 14, for up to 6 weeks of in-lab use and monthly throughout the home usage portion of the study.
Sponsors and collaborators: Veterans Affairs Office of Research and Development
Contact: Kate J Barnabe, MHA, 401-273-7100 ext. 6272, kate.barnabe@va.gov; Frantzy Acluche, MSc, 401-273-7100 ext. 6274, frantzy.acluche@va.gov
Information acquired from: Veterans Affairs (VA) Office of Research and Development, via clinicaltrials.gov
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