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Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

Primary Purpose

Lower-limb Orthoses, Frailty/Sarcopenia, Chronic Overuse Musculoskeletal Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modular powered orthosis
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lower-limb Orthoses

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rehab Lab, University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exoskeleton

Arm Description

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

Outcomes

Primary Outcome Measures

Powered orthosis effect
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/lowering
Time to complete 10 reps of L&L will be measured post-fatigue in healthy subjects.
User satisfaction
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 speed
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

Thorax angle
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.

Full Information

First Posted
January 13, 2022
Last Updated
September 18, 2023
Sponsor
University of Michigan
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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1. Study Identification

Unique Protocol Identification Number
NCT05240014
Brief Title
Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
Official Title
Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower-limb Orthoses, Frailty/Sarcopenia, Chronic Overuse Musculoskeletal Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton
Arm Type
Experimental
Arm Description
Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis
Intervention Type
Device
Intervention Name(s)
Modular powered orthosis
Intervention Description
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 Information:
Title
Powered orthosis effect
Description
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 Frame
1 day
Title
Time to complete 10 reps of lifting/lowering
Description
Time to complete 10 reps of L&L will be measured post-fatigue in healthy subjects.
Time Frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Title
User satisfaction
Description
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.
Time Frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Title
Gait speed
Description
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.
Time Frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Secondary Outcome Measure Information:
Title
Thorax angle
Description
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.
Time Frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Klinkman, MS
Phone
734-846-0046
Email
emilykk@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Gregg, PhD
Phone
734-763-1156
Email
rdgregg@umich.edu
Facility Information:
Facility Name
Rehab Lab, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Klinkman, MS
Phone
734-846-0046
Email
emilykk@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

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