MedPath

Enhancing Voluntary Motion in Broad Patient Populations with Modular Powered Orthoses

Not Applicable
Recruiting
Conditions
Lower-limb Orthoses
Chronic Overuse Musculoskeletal Injuries
Frailty/Sarcopenia
Interventions
Device: Modular powered orthosis
Registration Number
NCT05240014
Lead Sponsor
University of Michigan
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
33
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ExoskeletonModular powered orthosisParticipants in this arm of the study will perform various tasks while wearing the modular powered orthosis
Primary Outcome Measures
NameTimeMethod
Powered orthosis effect1 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 in normalized exertion between the orthosis condition and no-orthosis condition, averaging across tasks and muscles measured for the joint module to compute the "powered orthosis effect" for each subject.

Time to complete 10 reps of lifting/lowering1 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.

User satisfaction1 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 QUEST survey.

Gait speed1 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.

Secondary Outcome Measures
NameTimeMethod
Thorax angle1 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.

Trial Locations

Locations (1)

Rehab Lab, University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

© Copyright 2025. All Rights Reserved by MedPath