NCT05989243 Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
| NCT ID | NCT05989243 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Transtibial Amputation |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-01-31 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-01-31 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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)
Contact & Investigator
Alena Grabowski, PhD BA
PRINCIPAL INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO
Frequently Asked Questions
Who can join the NCT05989243 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Transtibial Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989243 currently recruiting?
Yes, NCT05989243 is actively recruiting participants. Contact the research team at Alena.Grabowski@va.gov for enrollment information.
Where is the NCT05989243 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05989243 clinical trial?
NCT05989243 is sponsored by VA Office of Research and Development. The principal investigator is Alena Grabowski, PhD BA at Rocky Mountain Regional VA Medical Center, Aurora, CO. The trial plans to enroll 40 participants.