A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton
NCT ID: NCT04648878
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2021-02-14
2024-12-18
Brief Summary
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Detailed Description
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* Determining if the subject is a candidate for exoskeleton treatment.
* Randomly assigning subjects to three groups (physical therapy only, exoskeleton only, or a hybrid of physical therapy and exoskeleton).
* Body measurements to individualize the fit of the exoskeleton to each subject at each session.
* Activities-based balance confidence (ABC) questionnaire will be administered before and after the study begins.
* Timed up and go test (TUGT).
* Ten-meter walk test (10MWT).
* Six-minute walk test (6MWT)
* Berg Balance Test (BBT).
* Five times sit to stand (5XSTS).
* Heart rate through a portable heartrate monitor.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Group A - Hybrid combination
Group A (n=12) will receive 18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks.
Hybrid combination of physical therapy and powered exoskeleton
18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks
Group B - Powered Exoskeleton only
Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks.
Powered Exoskeleton Only
18 visits of powered exoskelton only, three times a week for approximately 6 weeks
Group C - Physical Therapy only
Group C (n=12) will receive 18 visits of physical therapy, three times a week for approximately 6 weeks. Upon completion of the data collection portion of the study, group C will receive 9 sessions, three times a week for approximately three weeks of powered exoskeleton therapy. Data will not be collected or reported during this phase, but but may be retained for future approved use.
Physical Therapy only
18 visits of physical therapy only, three times a week for approximately 6 weeks
Interventions
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Hybrid combination of physical therapy and powered exoskeleton
18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks
Powered Exoskeleton Only
18 visits of powered exoskelton only, three times a week for approximately 6 weeks
Physical Therapy only
18 visits of physical therapy only, three times a week for approximately 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 3 Ashworth score are involved in a standing program less than 220 lbs 5'0" through 6'4" have the ability to follow one-step commands near normal range-of-motion for the knees, hips, and ankles
18 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Michael Davidson, MSE MPH
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University O&P
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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Other Identifiers
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5190407
Identifier Type: -
Identifier Source: org_study_id
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