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
This trial accepts healthy volunteersQualifiers
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 population
20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Conventional prosthetic socket
DeviceParticipants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for \~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
Adjustable Quatro socket
DeviceParticipants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for \~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Veterans with a transtibial amputation2 interventions
Group B: Veterans with a transfemoral amputation2 interventions
Trial outcomes
Primary outcomes
1
Biomechanical Asymmetry
The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. The investigators will compare asymmetry between groups and sockets.
Time frame
through study completion, an average of 4 years2
Prosthetic Evaluation Questionnaire
The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. The investigators will compare overall and domain-specific scores between groups and sockets.
Time frame
through study completion, an average of 4 yearsSecondary outcomes
1
Socket pistoning
Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets.
Time frame
through study completion, an average of 4 yearsSponsors and contacts
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Source ClinicalTrials.gov