Recruiting

Modular Powered Orthoses

Sponsor:

University of Michigan

Code:

NCT05240014

Conditions

Lower-limb Orthoses

Frailty/Sarcopenia

Chronic Overuse Musculoskeletal Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Modular powered orthosis

Study Details

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

Study ID

NCT05240014

Start date

Jul 29, 2022

Status verified date

Jul, 2025

Completion date

Sep 21, 2026

Anticipated

Primary completion date

Sep 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion criteria for able-bodied, young participants will be:

  • 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

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
  • 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

Inclusion criteria for elderly participants will be:

  • 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)

Exclusion criteria for elderly participants will be:

  • 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
  • Uncontrolled hypertension or diabetes
  • 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

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Exoskeleton

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

Interventions

Modular powered orthosis

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.

Primary outcome measure

  • Powered orthosis effect (muscle effort) [ Time Frame: 1 day ]
  • Time to complete 10 reps of lifting/lowering [ Time Frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis) ]
  • Gait speed [ Time Frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis) ]
  • Powered orthosis effect (biological torque) [ Time Frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis) ]
  • Minimum chair height for successful sit-to-stand [ Time Frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis) ]
  • Joint power [ Time Frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis) ]

Central Contacts and Locations

Central contacts

Emily Klinkman, MS

734-763-1156emilykk@umich.edu

Robert Gregg, PhD

734-763-1156rdgregg@umich.edu

Locations

Rehab Lab, University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Emily Klinkman, MS

734-763-1156emilykk@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-07-18.