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Enhancing Voluntary Motion with Modular Powered Orthoses

This study is testing a new device called a modular powered orthosis. This device is designed to fit your specific weakened joints and help improve your natural movement. Researchers want to see if these orthoses can help people with conditions like frailty, sarcopenia (muscle loss), or chronic overuse injuries. They will measure how much muscle effort you use, how quickly you can complete lifting tasks, and your walking speed, both with and without the orthosis. The study is looking for 33 participants, aged 18 to 85, including healthy young adults who can lift a 10 kg weight. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 33 participants. It is not specified if it's randomized or blinded.
What's involved
Participants will be assessed on muscle effort, time to complete lifting tasks, and gait speed, all measured at one day.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one day, based on the primary endpoint measurements.

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NCT05240014

Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses

Recruiting
NAAges 18–85Interventional
University of Michigan
~33 participants
Updated 2025-07-18 on ClinicalTrials.gov
What's tested:Modular powered orthosis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Powered orthosis effect (muscle effort)
Measured over 1 day
+5 more outcomes measured

Conditions

Lower-limb Orthoses
Frailty/Sarcopenia
Chronic Overuse Musculoskeletal Injuries

Explore related trials

Chronic Overuse Musculoskeletal InjuriesFrailtySarcopenia

Where it's being run

1 sites across 1 states
Michigan1

Who to contact

Emily Klinkman, MS
[email protected]
734-763-1156
Email the study team

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Eligibility criteria

Inclusion

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
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

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
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

What this trial measures

  • Powered orthosis effect (muscle effort)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/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.

  • 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.

  • Powered orthosis effect (biological torque)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-stand1 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 power1 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.