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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