Lower-limb OrthosesNCT05240014
Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
A study testing Modular powered orthosis in people with Lower-limb Orthoses and Frailty/Sarcopenia, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower-limb Orthoses, Frailty/Sarcopenia, Chronic Overuse Musculoskeletal Injuries
- What is being tested?
- Modular powered orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2022to 21 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rehab Lab, University of Michigan
Ann Arbor, Michigan, 48109
Emily Klinkman, MS, 734-763-1156, emilykk@umich.edu
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. 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.
Read the 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.
- Being tested
- Modular powered orthosis
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular powered orthosisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton | Experimental | Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis Receives: Device: Modular powered orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Powered orthosis effect (muscle effort)
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.
Measured: 1 day
Time to complete 10 reps of lifting/lowering
Time to complete 10 reps of L\&L will be measured post-fatigue in healthy subjects.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
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.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Powered orthosis effect (biological torque)
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.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Minimum chair height for successful sit-to-stand
We will evaluate the minimum chair height from which elderly participants can successfully rise with and without the knee exoskeleton.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Joint power
For elderly participants, we will evaluate the peak values of biological and total (exo+biological) joint power with and without the exoskeleton.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Secondary outcomes (3)
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 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".
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
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.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Stair ascent gait style
Step-to-step vs. step-over-step gait style will be evaluated for the exo condition vs no exo condition for elderly participants.
Measured: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start29 Jul 2022
- Primary completion20 Sep 2026 (estimated)
- Study completion21 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower-limb OrthosesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Robert D Gregg, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240014
- Sponsor's protocol ID
- HUM00201957
- Other IDs
- R01EB031166
- Status last verified
- Jul 2025
- First submitted
- 13 Jan 2022
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
- ClinicalTrials.gov ID
- NCT05240014
- Acronym / sponsor ID
- HUM00201957
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 21 Sep 2026 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton | Experimental | Device: Modular powered orthosisParticipants in this arm of the study will perform various tasks while wearing the modular powered orthosis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modular powered orthosisThis 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. | Device | Exoskeleton |
Primary outcome
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.
3 secondary outcomes
User satisfaction
Time frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Thorax angle
Time frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Stair ascent gait style
Time frame: 1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modular powered orthosis in people with Lower-limb Orthoses and Frailty/Sarcopenia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Klinkman, MS (734-763-1156, emilykk@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Powered orthosis effect (muscle effort) (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.