Stability Measurement for Lower Limb Amputation

(CS Trial)

Overseen By Jason Maikos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active wounds, Rapid limb volume changes, Cognitive deficits, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alexis Sidiropoulos, PhD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

This trial is for Veterans who have lost a lower limb and are seeking to improve their mobility. Participants should be interested in using technology like 3D motion capture and wearable devices to track their stability during movement.

Inclusion Criteria

I have lost one leg below the knee.

Well-fitting prosthesis for a minimum of one month as determined by a board-certified prosthetist

I can move around and transfer with minimal help.

Exclusion Criteria

My prosthetic socket does not fit well.

I have wounds or severe joint issues on my intact limb affecting movement tests.

I have no mental conditions that affect my understanding or ability to follow directions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including TUG, 6MWT, SAI, HAI, and AMPPro tests

1 week

1 visit (in-person)

Reliability Testing

Participants undergo 3 sessions of 3-D gait analysis and wearable technology assessment to measure test re-test reliability

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main assessments

4 weeks

Treatment Details

Trial Overview The study aims to test the reliability and validity of measuring continuous inter-limb stability in individuals with lower limb loss. It will use accessible technologies, such as wearable devices, compared to expensive lab equipment.

Participant Groups

Group I: Reliability and Validity Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+