The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke, Acute
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Change in Timed Stair Climb Test speed from baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Hypothesis/Specific Aims: The purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb stairs in individuals affected by recent stroke as compared to stair climbing training without an exoskeleton.
Detailed Description
Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions. Group 2 will not wear the exoskeleton device during training sessions. All screening and evaluation sessions will be completed without the exoskeleton device for both Group 1 and Group 2. Pre and post-session vitals (blood pressure, heart rate) will be taken and monitored throughout the session as needed. Gait belts and/or overhead track and harnessing systems will be used throughout sessions as needed for increased safety of participants. Skin integrity will also be monitored both before and after each use of the exoskeleton device. Each enrolled participant will complete the following sessions: Session 1: Screening * After consenting, subjects will undergo a physical evaluation and screening exam by a licensed physical therapist. If they meet study criteria, they will be randomly placed into either the Keeogo group or the traditional stair training group using a random number generator and they will be entered into the study. Once they are enrolled, baseline outcome measures will be assessed. Sessions 2 through 6: Training * Subjects will participate in 30 minutes of stair training with or without the exoskeleton device, depending on group assignment. Session 7: Post-Testing * Outcomes measures will once again be assessed by a licensed physical therapist.
Investigators
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab
Eligibility Criteria
Inclusion Criteria
- •Patient in the inpatient rehabilitation setting
- •less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (CVA)
- •No previous diagnosis or treatment for CVA
- •Acute inpatient rehabilitation discharge goal of stair negotiation
- •18 years of age or older
- •Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the Keeogo study device
- •Medical clearance from a Shirley Ryan AbilityLab (SRALAB) inpatient physician
Exclusion Criteria
- •Unwilling to participate
- •Unable to provide autonomous consent due to cognitive or communication impairment
- •Legally blind
- •Pregnant or lactating
- •Skin condition that contraindicates use of orthotics or support braces
- •History of multiple CVA
- •History of any additional neuropathology diagnosis, such as Parkinson's disease, multiple sclerosis, traumatic brain injury, or spinal cord injury
Outcomes
Primary Outcomes
Change in Timed Stair Climb Test speed from baseline
Time Frame: Initial Visit (Week 1); Post testing (Week 2)
The timed stair test is best conducted in a standard interior stair-well with guard rails and preferably 10 steps between landings, with a minimum of 8 steps and a maximum of 12 steps. The landing space is required to ensure safe turning. The patient will be instructed to ascend and descend the stair case "as quickly and safely" as possible. To start the test, the patient is asked to stand at the bottom of the stair case, and a countdown provided "one, two, ready, go" where the patient initiates stair ascent at the "go" cue, and the tester starts the stop watch. • The patient ascends the stair case, turns and descends the stair case, coming to a stop at the bottom of the stair case. The tester will lap the time for the ascent period and the descend period, and records these "Test 1" times. This will be repeated for a total of two trials.
Secondary Outcomes
- 5-times Sit to Stand Test(Initial Visit (Week 1); Post testing (Week 2))
- GAITRite Data Collection(Initial Visit (Week 1); Post testing (Week 2))