A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton

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.

Official Title
-----------------
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.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Hybrid combination of physical therapy and powered exoskeleton
* Other: Powered Exoskeleton Only
* Other: Physical Therapy only


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Hybrid combination<br>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<br>* 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<br>|
| Experimental: Group B - Powered Exoskeleton only<br>Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks. | Other: Powered Exoskeleton Only<br>* 18 visits of powered exoskelton only, three times a week for approximately 6 weeks<br>|
| Experimental: Group C - Physical Therapy only<br>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<br>* 18 visits of physical therapy only, three times a week for approximately 6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Exoskeleton, Gait, Physical Therapy, Motor-learning