Clinical trial NCT03264235: The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA
Official title: The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Gait Disorders, Neurologic
Keywords: Powered-Knee Exoskeleton
Stair Training
Keeogo
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2017-08-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions and will participate in 30 minutes of stair training in the device. Group 2 will not wear the exoskeleton device during training sessions and will be participate in 30 minutes of stair training without the device.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Timed Stair Climb Test speed from baseline
timeFrame: Initial Visit (Week 1); Post testing (Week 2)
Secondary outcomes:
measure: 5-times Sit to Stand Test
timeFrame: Initial Visit (Week 1); Post testing (Week 2)
measure: GAITRite Data Collection
timeFrame: Initial Visit (Week 1); Post testing (Week 2)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan Ability Lab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: