Reliability and Validity of Continuous Inter-limb Stability (NCT06987019) | Clinical Trial Compass
RecruitingNot Applicable
Reliability and Validity of Continuous Inter-limb Stability
United States20 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reliability of Continuous Inter-limb Stability
Timeframe: 3 times at visits 2-4 (once per visit) (will occur within 1 week)
2
Convergent Validity of Continuous Inter-limb Stability - TUG
Timeframe: Once at visit 2 of 4 (Baseline)
3
Convergent Validity of Continuous Inter-limb Stability - 6MWT
Timeframe: Once at visit 2 of 4 (Baseline)
4
Convergent Validity of Continuous Inter-limb Stability - SAI
Timeframe: Once at visit 2 of 4 (Baseline)
5
Convergent Validity of Continuous Inter-limb Stability - HAI
Timeframe: Once at visit 2 of 4 (Baseline)
6
Convergent Validity of Continuous Inter-limb Stability - AMPPro