Modular powered knee braces to help move better and reduce knee pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to develop modular, lower-limb powered orthoses that attach to the knee and provide controlled torque to assist voluntary movement. The system uses a quasi-direct drive actuator and a neural network controller that shapes energy delivery across various daily activities without fixed gait patterns. The study will include adults with knee osteoarthritis and a separate group of able-bodied adults to test safety, feasibility, and device performance in real-world tasks. The goal is to determine whether 15-30% joint torque from the device can decrease muscle effort and knee pain during activities of daily living. Feasibility, user comfort, and initial functional outcomes will guide future development.

Why it matters

Who can join: the full rules

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

Where it's running

• Rehab Lab
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Study coordinator: Kashvi Pota, MS
• Email: kashvip@umich.edu
• Phone: 734-763-1156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.