Status:
RECRUITING
Reliability and Validity of Continuous Inter-limb Stability
Lead Sponsor:
VA Office of Research and Development
Conditions:
Amputation, Lower Limb
Eligibility:
All Genders
18+ years
Phase:
NA
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 paramet...
Detailed Description
There is currently no valid or reliable biomechanical variable available to objectively measure the continuous stability of Veterans with lower limb loss. However, continuous inter-limb stability repr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06987019
Start Date
April 1 2025
End Date
December 31 2026
Last Update
May 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011