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Clinical Trials/NCT05240014
NCT05240014
Recruiting
N/A

Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

University of Michigan1 site in 1 country33 target enrollmentJuly 29, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lower-limb Orthoses
Sponsor
University of Michigan
Enrollment
33
Locations
1
Primary Endpoint
Powered orthosis effect (muscle effort)
Status
Recruiting
Last Updated
9 months ago

Overview

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.

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 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.

Registry
clinicaltrials.gov
Start Date
July 29, 2022
End Date
September 21, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert D Gregg

Associate Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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

  • 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 Sites (1)

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