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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.
This prospective randomized control trial with three treatment arms will begin by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Hybrid combination | Experimental | 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. |
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| Group B - Powered Exoskeleton only | Experimental | Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks. |
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| Group C - Physical Therapy only | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid combination of physical therapy and powered exoskeleton | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Timed up and go test | 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. | Pre and post tests up to six weeks apart |
| Ten meter walk test | 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. | Pre and post tests up to six weeks apart |
| 6 minute walk test | 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 | Pre and post tests up to six weeks apart |
| Berg Balance Test | 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 | Pre and post tests up to six weeks apart |
| The Activities-specific Balance Confidence (ABC) Scale | 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. | Pre and post tests up to six weeks apart |
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Inclusion Criteria:
Males and Females 18 years of age or older post-stroke
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Davidson, MSE MPH | Loma Linda University O&P | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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participants will be instructed to not reveal which treatment arm they have been assigned to
| Powered Exoskeleton Only | Other | 18 visits of powered exoskelton only, three times a week for approximately 6 weeks |
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| Physical Therapy only | Other | 18 visits of physical therapy only, three times a week for approximately 6 weeks |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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