Measuring stability in Veterans with lower limb loss
Official title: Reliability and Validity of Continuous Inter-Limb Stability in Veterans With Lower Limb Loss
Run by VA Office of Research and Development · NCT06987019 · Data updated 2026-11-12
This study tests a new way to measure balance in Veterans with lower limb loss to see if it can help improve their mobility and quality of life during rehabilitation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT06987019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with unilateral transtibial limb loss who have a well-fitting prosthesis and can achieve modified independence in mobility.
✕Probably not a fit
Patients with active wounds, significant musculoskeletal comorbidities, or cognitive deficits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to establish a reliable and valid measure of continuous inter-limb stability for Veterans with lower limb loss, specifically those with transtibial amputation. By utilizing a novel methodology called Relative Phase (RP) analysis, the research will assess stability in a clinical setting using accessible wearable technology rather than expensive laboratory equipment. The goal is to improve functional mobility and quality of life for these individuals through better rehabilitation practices based on the findings. This study addresses a significant gap in the current assessment tools available for healthcare providers treating this population.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies that enhance mobility and quality of life for Veterans with limb loss.
How similar studies have gone: While previous studies have explored continuous stability in mobility-challenged populations, this specific approach using RP analysis for Veterans with limb loss is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any individual with unilateral transtibial limb loss * A well-fitting prosthesis (as determined by a board-certified prosthetist through standardized prosthetic guidelines) for a minimum of one month * Able to achieve a "Level 6 - Modified Independence" score on the Functional Independence Measure (FIM) for 2 mobility items (locomotion and transfers) Exclusion Criteria: * Individuals with active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair ability to participate in biomechanical evaluations * Any comorbidity that results in rapid limb volume changes (i.e., end stage renal disease with dialysis) * A poorly fitting socket * Cognitive deficit(s) or mental pathology (e.g., dementia, amnesia) that would prevent the participant from understanding and following directions and limit the participant's ability to participate fully in the study * Women who are pregnant or who plan to become pregnant during their participation in study activities * Functional Independence Measure (FIM) scores less than Level 6 for locomotion and transfers
Where it's running
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VA NY Harbor Healthcare System, New York, NY
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Alexis Sidiropoulos, PhD — VA NY Harbor Healthcare System, New York, NY
- Study coordinator: Alexis Sidiropoulos, PhD
- Email: alexis.sidiropoulos@va.gov
- Phone: (212) 686-7500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.