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NCT Number: NCT05240014

Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehab Lab, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Emily Klinkman, MS

CONTACT

[email protected]

734-763-1156

About this study

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. Conventional orthoses tend to immobilize joints, and emerging powered orthoses constrain voluntary motion by using highly geared electric motors and/or control methods that force the user to follow a specific gait pattern. Consequently, these devices have not seen widespread success across populations with weakened voluntary control due to advanced age, musculoskeletal disorders, etc. These heterogeneous populations require partial, not full, assistance of user-specific muscle groups during daily activities. However, there is a fundamental gap in knowledge about how to design and control powered orthoses to assist the user without constraining their motion. The central hypothesis of this project 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. This project aims to establish feasibility of assisting different populations with 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Powered orthosis effect (muscle effort)

    Time frame: 1 day

    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.

  2. Time to complete 10 reps of lifting/lowering

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

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

  3. Gait speed

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

    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.

  4. Powered orthosis effect (biological torque)

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

    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.

  5. Minimum chair height for successful sit-to-stand

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

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

  6. Joint power

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

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

Secondary outcomes

  1. User satisfaction

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

    User satisfaction / perception of device effectiveness over an ambulation circuit (sit-to-stand, walk up and down a ramp, walk up and down a staircase) will be measured post-fatigue in healthy subjects using a modified Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) survey. The purpose of the scale is to evaluate user device satisfaction and consists of 12 items asking the user to rate their satisfaction on a scale of 1 to 5, where 1 = "not satisfied at all" and 5 = "very satisfied".

  2. Thorax angle

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

    This is the global thorax angle (with respect to vertical) during a lifting/lowering cycle. This will be a secondary outcome measure for able-bodied subjects.

  3. Stair ascent gait style

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

    Step-to-step vs. step-over-step gait style will be evaluated for the exo condition vs no exo condition for elderly participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Klinkman, MS

CONTACT

[email protected]

734-763-1156

Robert Gregg, PhD

CONTACT

[email protected]

734-763-1156

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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