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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07673328
Status
Recruiting
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Conditions

  • Lower-limb Orthoses
  • Osteoarthritic Knee Pain
  • Osteoarthritis (OA) of the Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Modular powered orthosis — DEVICE
    This study will investigate 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. The central hypothesis is that high-torque, low-inertia motor systems controlled with energetic objectives will enable modular powered orthoses to partially assist the joints. High-torque electric motors combined with minimal transmissions can be freely rotated (i.e., backdriven) by human joints, allowing the use of an emerging torque control method called energy shaping to reduce the perceived weight/inertia of the body during any motion. By mounting these modular actuators to commercial orthoses, this technology will be easily prescribed/configured by clinicians.

Study Details

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.

Key Dates

Start date
Jul 18, 2025
Status verified
Jun 2026
Primary completion
Mar 30, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Exoskeleton
    Experimental: Exoskeleton Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis

Primary Outcome Measure

Muscle effort [ Time Frame: Baseline and through study completion, an average of 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rehab LabAnn ArborMichigan48109
Emily Klinkman
[email protected]
734-763-1156
Robert Gregg (PRINCIPAL_INVESTIGATOR)

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By research site
Rehab Lab· Ann Arbor, MI

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