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Reliability and Validity of Continuous Inter-limb Stability

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT06987019

Registry updated: 2026-09-30

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Description

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.

Interventions

3D motion capture, wearable devices, and functional outcome measures (Other)
Gait evaluation, Hill and Stair Assessment Indices, 6 minute walk test, AMPPro, Timed Up and Go

Eligibility 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

Conditions

Amputation, Lower Limb

Locations

VA NY Harbor Healthcare System, New York, NY — New York, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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