NCT05989243

Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Transtibial Amputation
• Transfemoral Amputation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-31
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-08-14
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States