Stroke
Conditions
Keywords
Stroke, Exoskeleton, Gait, Physical Therapy, Motor-learning
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.
Interventions
OTHERHybrid 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
OTHERPowered Exoskeleton Only
18 visits of powered exoskelton only, three times a week for approximately 6 weeks
OTHERPhysical Therapy only
18 visits of physical therapy only, three times a week for approximately 6 weeks
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
participants will be instructed to not reveal which treatment arm they have been assigned to
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed