Modular powered orthoses to enhance movement in patients
Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
This study is testing new powered leg braces to see if they can help people with weak joints move better and improve their everyday activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05240014 on ClinicalTrials.gov |
What this trial studies
This project focuses on developing modular, lower-limb powered orthoses designed to assist user-specific weakened joints and enhance voluntary motion across diverse patient populations. The study aims to establish the feasibility of these orthoses in improving lifting and lowering postures in able-bodied individuals and functional outcomes in elderly subjects. By utilizing high-torque, low-inertia motor systems, the orthoses will provide partial assistance without constraining natural motion, addressing a significant gap in current orthotic technology. The modular design allows for easy prescription and configuration by clinicians, making it accessible for various users.
Who should consider this trial
Good fit: Ideal candidates include able-bodied individuals aged 18 to 65 who can perform specific physical tasks and elderly patients with mobility challenges.
Not a fit: Patients with significant neuromuscular or musculoskeletal disorders, cognitive deficits, or those unable to perform basic physical tasks may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve mobility and quality of life for patients with weakened lower-limb musculature.
How similar studies have performed: While there is ongoing research in powered orthoses, this specific modular approach is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for able-bodied, young participants will be: * Aged between 18 to 65 years * Weigh less than 250 lbs due to limitations in the design of the orthoses * Ability to lift and lower a 10 kg weight using the neutral-spine squat technique for 10 repetitions Exclusion criteria for able-bodied, young adult participants will be: * Pregnant (self-report) * Any significant neuromuscular or musculoskeletal disorder that would interfere with the study * Prior history of chronic lower-back pain * Unable to walk for 20 minutes * History of any cardiovascular, vestibular, or visual diseases and/or impairments that may interfere with the study * Cognitive deficits that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments. Cognitive deficits will be determined by a Mini-Mental State Examination (MMSE) score of \<22. * Adults with a known allergy to medical grade tape Inclusion criteria for elderly participants will be: * Aged between 65 to 85 years * Weigh less than 250 lbs due to limitations in the design of the orthoses * Ability to walk 6 minutes without assistance from a person (may use walking aid) Exclusion criteria for elderly participants will be: * Pregnant (self-report) * Significant pain due to arthritis or other joint problems that would limit their ability to walk * Any recent lower-extremity fracture (within 3 months) * Significant neurological (e.g., stroke), orthopedic, or cardiovascular disorder that may affect the ability to walk * Advised by a physician not to walk or exercise * Uncontrolled hypertension or diabetes * Cognitive deficits or visual impairment that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments. Cognitive deficits will be determined by a Mini-Mental State Examination (MMSE) score of \<22. * Adults with a known allergy to medical grade tape
Where this trial is running
Ann Arbor, Michigan
- Rehab Lab, University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Emily Klinkman, MS
- Email: emilykk@umich.edu
- Phone: 734-763-1156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.