CompletedNot Applicable

Evaluating Mobility Interventions in the Real World

United States20 participantsStarted 2021-09-03

Plain-language summary

This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study. Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Target Populations: * Participants with amputation must have used a prosthesis for more than 6 months, and wear it for at least 8 hours per day. * Participants must be more than 6 months past their most recent surgery (if any). * Participants must be free of musculoskeletal and cardiovascular conditions that would limit their ability to safely complete testing. * Participants should consider themselves in good health; be able to wear their prostheses or orthoses all day long; be able to perform all of their activities of daily living (ADL) with their prostheses or orthoses as appropriate; have a comfortably fitting functional prosthesis (if applicable) that does not cause any skin problems; and have a stable residual limb (or impaired limb). * Participants may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid but not a small-base quad cane or walker. * Participants must be able to walk with their prostheses or orthoses for 30 minutes (total) and stand for 30 minutes (total), in individual bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain or shortness of breath, or experiencing claudication symptoms. * Participants involved in running tests must be able to run for 30 minutes (total) in bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain, or experiencing claudication symptoms. * Participants must have no known cognitive disability. * Participants …

What they're measuring

Minimum Foot Clearance With Different Prostheses

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Minimum Foot Clearance With Different Orthoses

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions

Trial details

NCT IDNCT04275973

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

Results submitted2025-07-31

View on ClinicalTrials.gov More Lower Limb Amputation trials