A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton in the Treatment of Individuals With Sub-acute and Chronic Stroke.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Timed up and go test
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Masking Description
participants will be instructed to not reveal which treatment arm they have been assigned to
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Exclusion criteria will include those who have already experienced powered exoskeleton therapy.
Arms & Interventions
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.
Intervention: Hybrid combination of physical therapy and powered exoskeleton (Other)
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.
Intervention: Powered Exoskeleton Only (Other)
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.
Intervention: Physical Therapy only (Other)
Outcomes
Primary Outcomes
Timed up and go test
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported