Status:

RECRUITING

Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Conditions:

Lower-limb Orthoses

Frailty/Sarcopenia

Eligibility:

All Genders

18-85 years

Phase:

NA

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 br...

Detailed Description

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 br...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 29 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 21 2026

    Estimated Enrollment :

    33 Patients enrolled

    Trial Details

    Trial ID

    NCT05240014

    Start Date

    July 29 2022

    End Date

    September 21 2026

    Last Update

    July 18 2025

    Active Locations (1)

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    Rehab Lab, University of Michigan

    Ann Arbor, Michigan, United States, 48109