Reliability and Validity of Continuous Inter-limb Stability

Recruiting now · Not applicable

Conditions studied: Amputation, Lower Limb

In brief

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.

Key facts

Study ID

NCT06987019

Run by

VA Office of Research and Development

People needed

20

Starts

2025-04-01

Expected to finish

2026-12-31

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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