Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

NCT05240014 | Recruiting FDA Device

• 2 other identifiers: HUM00201957R01EB031166
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to develop 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. This project aims to establish feasibility of assisting different populations with these modular powered orthoses. The investigators hypothesize that assisting lower-limb musculature with modular powered orthoses will improve 1) lifting/lowering posture in able-bodied subjects and 2) functional outcomes in elderly subjects.

Conditions

Lower-limb Orthoses; Frailty/Sarcopenia; Chronic Overuse Musculoskeletal Injuries

Outcome Measures

Primary Outcomes (6)

• Powered orthosis effect (muscle effort)

  For each orthosis module tested, electromyography (EMG) readings will be normalized per-muscle by the peak EMG observed during the no-orthosis condition, and then averaged over the cycle and across repetitions to obtain "normalized exertion" values. Performance will be assessed by the difference between the orthosis condition and no-orthosis condition, averaging across tasks and muscles measured for the joint module.

  1 day

• Time to complete 10 reps of lifting/lowering

  Time to complete 10 reps of L\&L will be measured post-fatigue in healthy subjects.

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

• Gait speed

  Gait speed will be determined by the time to complete a 10-meter walk test. This will be the primary outcome measure for elderly subjects.

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

• Powered orthosis effect (biological torque)

  For each orthosis module tested, peak biological torque (estimated by inverse dynamics) will be averaged across repetitions. Performance will be assessed by the difference between the orthosis condition and no-orthosis condition, averaging across tasks.

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

• Minimum chair height for successful sit-to-stand

  We will evaluate the minimum chair height from which elderly participants can successfully rise with and without the knee exoskeleton.

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

• Joint power

  For elderly participants, we will evaluate the peak values of biological and total (exo+biological) joint power with and without the exoskeleton.

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

Secondary Outcomes (3)

• User satisfaction

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

• Thorax angle

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

• Stair ascent gait style

  1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

Study Arms (1)

Exoskeleton

EXPERIMENTAL

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 250 lbs due to limitations in the design of the orthoses
• Ability to lift and lower a 10 kg weight using the neutral-spine squat technique for 10 repetitions

You may not qualify if:

• Pregnant (self-report)
• Any significant neuromuscular or musculoskeletal disorder that would interfere with the study
• Prior history of chronic lower-back pain
• 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
• Aged between 65 to 85 years
• Weigh less than 250 lbs due to limitations in the design of the orthoses
• Ability to walk 6 minutes without assistance from a person (may use walking aid)
• Pregnant (self-report)
• Significant pain due to arthritis or other joint problems that would limit their ability to walk
• Any recent lower-extremity fracture (within 3 months)
• Significant neurological (e.g., stroke), orthopedic, or cardiovascular disorder that may affect the ability to walk
• Advised by a physician not to walk or exercise

Sponsors & Collaborators

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

Study Sites (1)

Rehab Lab, University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Emily Klinkman, MS

CONTACT

734-763-1156; emilykk@umich.edu

Robert Gregg, PhD

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: Associate Professor

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 15, 2022
• Study Start: July 29, 2022
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 21, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)