Transtibial AmputationSocketFitNCT05989243
Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
An observational study of Transtibial Amputation and Transfemoral Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transtibial Amputation, Transfemoral Amputation
- What is being tested?
- Conventional prosthetic socket and Adjustable Quatro socket
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 31 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation
Who may be able to join
- 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
Who cannot join
- Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Alena Grabowski, PhD BA, 720-435-4270, Alena.Grabowski@va.gov
Alena Grabowski, PhD BA
About this study
Official title: Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation
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.
Read the 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
- Being tested
- Conventional prosthetic socket, Adjustable Quatro socket
- Keywords
- Biomechanics, Kinematics, Walking, Prostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional prosthetic socketDevice
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 socketDevice
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 group | Role | What they receive |
|---|---|---|
| Veterans with a transtibial amputation | 20 Veterans with a transtibial amputation, 10 females and 10 males Receives: Device: Conventional prosthetic socket; Device: Adjustable Quatro socket | |
| Veterans with a transfemoral amputation | 20 Veterans with a transfemoral amputation, 10 females and 10 males Receives: Device: Conventional prosthetic socket; Device: Adjustable Quatro socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 4 years
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.
Measured: through study completion, an average of 4 years
Secondary outcomes (1)
Socket pistoning
Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets.
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start31 Jan 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alena Grabowski, PhD BA, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989243
- Sponsor's protocol ID
- A3643-R
- Acronym
- SocketFit
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No