Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06987019

Conditions

Amputation, Lower Limb

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D motion capture, wearable devices, and functional outcome measures

Study Details

Brief summary:

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.

Conditions

Amputation, Lower Limb

Study ID

NCT06987019

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Reliability and Validity

Reliability and Validity of Inter-limb Stability using 3D motion capture, functional outcome measures, and wearable devices

Interventions

3D motion capture, wearable devices, and functional outcome measures

Gait evaluation, Hill and Stair Assessment Indices, 6 minute walk test, AMPPro, Timed Up and Go

Primary outcome measure

  • Reliability of Continuous Inter-limb Stability [ Time Frame: 3 times at visits 2-4 (once per visit) (will occur within 1 week) ]
  • Convergent Validity of Continuous Inter-limb Stability - TUG [ Time Frame: Once at visit 2 of 4 (Baseline) ]
  • Convergent Validity of Continuous Inter-limb Stability - 6MWT [ Time Frame: Once at visit 2 of 4 (Baseline) ]
  • Convergent Validity of Continuous Inter-limb Stability - SAI [ Time Frame: Once at visit 2 of 4 (Baseline) ]
  • Convergent Validity of Continuous Inter-limb Stability - HAI [ Time Frame: Once at visit 2 of 4 (Baseline) ]
  • Convergent Validity of Continuous Inter-limb Stability - AMPPro [ Time Frame: Once at visit 2 of 4 (Baseline) ]

Central Contacts and Locations

Central contacts

Alexis Sidiropoulos, PhD

(212) 686-7500alexis.sidiropoulos@va.gov

Jason Maikos, PhD

(212) 686-7500Jason.Maikos@va.gov

Locations

VA NY Harbor Healthcare System, New York, NY

Recruiting

New York, New York, United States, 10010-5011

Contacts

Alexis Sidiropoulos, PhD

212-686-7500alexis.sidiropoulos@va.gov

Principal Investigator:

Alexis Sidiropoulos, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Transtibial amputation
  • Gait evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-08.