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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
VA Office of Research and Development
Study ID
NCT05989243
Status
Recruiting
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Conditions

  • Transfemoral Amputation
  • Transtibial Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Conventional prosthetic socket — DEVICE
    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.
  • Adjustable Quatro socket — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2022
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Veterans with a transtibial amputation
    20 Veterans with a transtibial amputation, 10 females and 10 males
  • Arm: Veterans with a transfemoral amputation
    20 Veterans with a transfemoral amputation, 10 females and 10 males

Primary Outcome Measure

Biomechanical Asymmetry [ Time Frame: through study completion, an average of 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VA Medical Center, Aurora, COAuroraColorado80045-7211
Alena Grabowski, PhD BA
[email protected]
720-435-4270
Alena Grabowski, PhD BA (PRINCIPAL_INVESTIGATOR)

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By research site
Rocky Mountain Regional VA Medical Center, Aurora, CO· Aurora, CO

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