|

Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal

RECRUITINGN/ASponsored by University of Michigan
Actively Recruiting
PhaseN/A
SponsorUniversity of Michigan
Started2025-07-18
Est. completion2030-03-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
Locations1 site

Summary

The overall goal of this project is to establish a novel design and control paradigm for modular, partial-assist powered orthoses (exoskeletons) to enhance voluntary lower-limb motion and manage pain in broad patient populations. Building upon a previous study period that addressed weakness from advanced age or muscle fatigue, this current period extends the technology to novel powered unloader orthoses designed to manage knee osteoarthritis (OA) pain. The investigators hypothesize that by providing 15-30% of biological joint torque, these motorized devices can reduce muscular contributions to painful loads on the joint's surfaces during activities of daily living (ADLs). The project aims to develop a task-agnostic, neural network-based controller and establish the feasibility of reducing knee pain and muscle effort in individuals with multi-compartment knee osteoarthritis.

Eligibility

Age: 18 Years – 85 YearsHealthy volunteers accepted
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

Conditions4

ArthritisLower-limb OrthosesOsteoarthritic Knee PainOsteoarthritis (OA) of the Knee

Locations1 site

Rehab Lab
Ann Arbor, Michigan, 48109
Emily Klinkman734-763-1156emilykk@umich.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.