Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
- NCT ID
- NCT07673328
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- University of Michigan
- Conditions
- Lower-limb Orthoses, Osteoarthritic Knee Pain, Osteoarthritis (OA) of the Knee
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 65 participants (Estimated).
What is being studied
- Device: Modular powered orthosis
Who may be eligible
- Ages
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers accepted
- Yes
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
Inclusion criteria for able-bodied, young participants will be:
* Aged between 18 to 65 years
* Weigh less than 300 lbs (due to challenges in bracing heavier participants)
* BMI \< 40 (due to challenges in bracing heavier participants)
Inclusion criteria for knee osteoarthritis participants will be:
* Aged between 30 to 85 years
* Medical diagnosis of patellofemoral and tibiofemoral osteoarthritis
* Patient reported pain ≥ 4 out of 10 during activities of daily life (to avoid floor effects)
* Weigh less than 300 lbs (due to challenges in bracing heavier participants)
* BMI \< 40 (due to challenges in bracing heavier participants)
* Ability to walk 6 minutes without assistance from a person (may use walking aid)
* Ability to ascend/descend ramps and stairs with or without the use of handrails
Exclusion Criteria:
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
* 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
Exclusion criteria for knee osteoarthritis participants will be:
* Pregnant (self-report)
* Any recent lower-extremity fracture (within 6 months)
* Significant limitation on knee joint range of motion
* Significant neurological (e.g., stroke) or cardiovascular disorder that may affect the ability to walk
* Advised by a physician not to walk or exercise
* Uncontrolled hypertension or diabetes
* Use of opioids
* 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
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
- Michigan, United States: 1
Sample of listed locations
- Rehab Lab — Ann Arbor, Michigan, 48109, United States — Recruiting
Study details
- Start date
- July 18, 2025
- Primary completion date
- March 30, 2030
- Completion date
- March 31, 2030
- First posted
- June 29, 2026
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07673328
- Registry last updated
- September 30, 2026
- QualifiedStudies registry data refreshed
- October 5, 2026
- QualifiedStudies record fetched
- October 5, 2026
View NCT07673328 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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