Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional prosthetic socket, Adjustable Quatro socket.
- Who it may be relevant to
- Registry conditions: Transtibial Amputation, Transfemoral Amputation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation
Overview
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.
Detailed description
The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.
Interventions
- Device Conventional prosthetic socket
Participants 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. - Device Adjustable Quatro socket
Participants 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.
Primary outcome measures
- Biomechanical Asymmetry [Time frame: through study completion, an average of 4 years]
- Prosthetic Evaluation Questionnaire [Time frame: through study completion, an average of 4 years]
Secondary outcome measures (1)
- Socket pistoning [Time frame: through study completion, an average of 4 years]
Eligibility criteria
Inclusion criteria
- 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
- Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator
Exclusion criteria
- Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Identifiers
NCT: NCT05989243 · A3643-R