NCT05240014 Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
| NCT ID | NCT05240014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Lower-limb Orthoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2022-07-29 |
| Primary Completion | 2026-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2022-07-29 with a primary completion date of 2026-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall goal of this project is to develop modular, lower-limb, powered orthoses that fit to user-specific weakened joints and control force/torque in a manner that enhances voluntary motion in broad patient populations. This project aims to establish feasibility of assisting different populations with these modular powered orthoses. The investigators hypothesize that assisting lower-limb musculature with modular powered orthoses will improve 1) lifting/lowering posture in able-bodied subjects and 2) functional outcomes in elderly subjects.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05240014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Lower-limb Orthoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05240014 currently recruiting?
Yes, NCT05240014 is actively recruiting participants. Contact the research team at emilykk@umich.edu for enrollment information.
Where is the NCT05240014 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05240014 clinical trial?
NCT05240014 is sponsored by University of Michigan. The trial plans to enroll 33 participants.