Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Modular powered orthosis
DeviceThis 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.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: ExoskeletonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 day2
Time to complete 10 reps of lifting/lowering
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)3
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.
Time frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)4
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.
Time frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)Secondary outcomes
1
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".
Time frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)2
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.
Time frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)3
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.
Time frame
1 day, assessed per experimental condition (i.e. with orthosis and without orthosis)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov