Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorVA Office of Research and Development
About this trial
The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.
Eligibility criteria
Qualifiers
The investigators will enroll up to 40 Veterans
20 with unilateral transtibial amputation
20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
Disqualifiers
Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Trial design
Treatments tested in this trial
- Conventional prosthetic socket
- Adjustable Quatro socket
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov