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

NCT07673328 | Recruiting FDA Device

• 2 other identifiers: HUM00201957_Period2R01EB031166
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Muscle effort

  Muscle activity will be measured by surface EMG electrodes, and EMG sites will be averaged by flexors and extensors. For each condition (no orthosis vs. powered orthosis), signals will be normalized by their peaks during the no-orthosis condition, and then averaged over cycle, repetitions, and tasks to obtain overall muscle effort (focusing on knee extension for the powered knee orthosis, hip extension and flexion for the powered hip orthosis, and ankle plantarflexion for the powered ankle orthosis).

  Baseline and through study completion, an average of 2 months

• Joint moment load

  Biological torques will be estimated by subtracting the assistive torques from the total joint torques computed via inverse dynamics (using OpenSim). Biological torques will be divided into flexion and extension. For each condition (no orthosis vs. powered orthosis), signals will be normalized by their peaks during the no-orthosis condition, and then averaged over cycle, repetitions, and tasks to obtain overall joint moment load (focusing on knee extension for the powered knee orthosis, hip extension and flexion for the powered hip orthosis, and ankle plantarflexion for the powered ankle orthosis).

  Baseline and through study completion, an average of 2 months

• Pain score

  The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess perceived pain for a multi-activity circuit test and isolated activity tests. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). It is an extension of the WOMAC Osteoarthritis Index. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.

  Baseline and through study completion, an average of 2 months

Secondary Outcomes (5)

• 10-meter walk test

  Baseline and through study completion, an average of 2 months

• Joint range of motion

  Baseline and through study completion, an average of 2 months

• Joint compressive forces

  Baseline and through study completion, an average of 2 months

• Difficulty score

  Baseline and through study completion, an average of 2 months

• QUEST

  Baseline and through study completion, an average of 2 months

Study Arms (1)

Exoskeleton

EXPERIMENTAL

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

Device: Modular powered orthosis

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.

Exoskeleton

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Rehab Lab

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Emily Klinkman

CONTACT

734-763-1156; emilykk@umich.edu

Robert Gregg

CONTACT

734-763-1156; rdgregg@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Robotics Department Director, Locomotor Control Systems Laboratory

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 29, 2026
• Study Start: July 18, 2025
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

US (1)