Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
NCT ID: NCT05989243
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2022-01-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Veterans with a transtibial amputation
20 Veterans with a transtibial amputation, 10 females and 10 males
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.
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.
Veterans with a transfemoral amputation
20 Veterans with a transfemoral amputation, 10 females and 10 males
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Alena Grabowski, PhD BA
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO
Locations
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Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A3643-R
Identifier Type: -
Identifier Source: org_study_id
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