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Reliability and Validity of Continuous Inter-limb Stability

Reliability and Validity of Continuous Inter-Limb Stability in Veterans With Lower Limb Loss

Who can join

Ages 18 and older · All sexes

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
* FIM scores less than Level 6 for locomotion and transfers

About the study

To date, there is no valid and reliable measure of continuous inter-limb stability available to healthcare teams treating people with lower limb loss. Determining these characteristics of this parameter for this population is important because superior stability has been linked to increased physical activity and strength in similar populations, making it a potential vital contributor to mobility improvement of Veterans with limb loss. It is also crucial that healthcare providers can easily measure continuous stability in the clinic instead of relying on expensive laboratory equipment. The overall goals of this study are to determine the reliability and validity of continuous inter-limb stability of Veterans with lower limb loss and determine if this parameter can be captured using accessible wearable technology. Consequently, clinicians can improve continuous stability through proper rehabilitation to positively impact the functional mobility and overall quality of life of Veterans with lower limb loss.

What is being tested

• 3D motion capture, wearable devices, and functional outcome measures (other)

Sponsor: VA Office of Research and Development · Participants: 20 · Started: Apr 1, 2025

Contact the study team

• Alexis Sidiropoulos, PhD · Phone: (212) 686-7500
• Jason Maikos, PhD · Phone: (212) 686-7500

Official record on ClinicalTrials.gov — NCT06987019

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.