Reliability and Validity of Continuous Inter-limb Stability

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to measure something called "continuous inter-limb stability" in Veterans who have lost a lower limb. This measure is important because better stability can help improve physical activity and strength, which are crucial for better mobility and quality of life. The researchers want to see if they can reliably measure this stability using easy-to-access wearable technology, instead of relying on expensive lab equipment. The goal is to help healthcare providers support Veterans in their rehabilitation, ultimately enhancing their ability to move and live more independently.

To be eligible for this study, participants need to be Veterans with a unilateral transtibial limb loss (meaning they have lost a leg below the knee) and must have a well-fitting prosthesis for at least a month. They should also be able to perform certain mobility tasks independently. However, those with active wounds, significant issues with their remaining limb, or certain other health conditions will not be eligible. Participants can expect to contribute to important research that could lead to better support for others with similar challenges.

Gender

ALL

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
• • FIM scores less than Level 6 for locomotion and transfers