A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton
The purpose of this investigator-initiated study is to establish if powered exoskeleton therapy as a part of a rehabilitation program can be used as a standard of care in stroke rehabilitation.
|Condition or Disease||Intervention/Treatment||Phase|
This prospective randomized control trial with three treatment arms will begin by:
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.
Arms and Interventions
|Experimental: 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.
Other: 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
|Experimental: 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.
Other: Powered Exoskeleton Only
18 visits of powered exoskelton only, three times a week for approximately 6 weeks
|Experimental: 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.
Other: Physical Therapy only
18 visits of physical therapy only, three times a week for approximately 6 weeks
Primary Outcome Measures
- Timed up and go test [Pre and post tests up to six weeks apart]
Subject sits in a standard armchair and stands, and at a self-selected walking speed, walks 3 meters, turns, and walks back to the chair, and sits down. They will be timed. Takes three minutes to administer.
- Ten meter walk test [Pre and post tests up to six weeks apart]
Subjects will be timed as they walk a known distance of 10 meters to determine his self-selected walking velocity (distance/time). They will be timed. Takes five minutes to administer.
- 6 minute walk test [Pre and post tests up to six weeks apart]
This test measures distance walked in six minutes to assess a patient's physical endurance. They walk at a self-selected speed and will be timed. This test takes approximately 10 minutes to administer
- Berg Balance Test [Pre and post tests up to six weeks apart]
The Berg balance test is a reliable measure for predicting risk for fall. This 14-item test measures static and dynamic balance measures and takes 15-20 minutes to administer
- The Activities-specific Balance Confidence (ABC) Scale [Pre and post tests up to six weeks apart]
This has been shown to be an effective tool for assessing the psychological impact of balance impairment and falls and measuring an individual's balance confidence. Using a Likert scale, this self-administered test evaluates a person's confidence in balance over various activities. This 16-question test takes 5 to 10 minutes to complete.
Males and Females 18 years of age or older post-stroke
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
- Exclusion criteria will include those who have already experienced powered exoskeleton therapy.
Contacts and Locations
|1||Loma Linda University||Loma Linda||California||United States||92354|
Sponsors and Collaborators
- Loma Linda University
- Principal Investigator: Michael Davidson, MSE MPH, Loma Linda University O&P
Study Documents (Full-Text)None provided.