The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | August 30, 2017 |
| End Date: | December 2019 |
| Contact: | Arun Jayaraman, PT, PhD |
| Email: | ajayaraman@ricres.org |
| Phone: | 312-238-6875 |
The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
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.
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.
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.
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.
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
We found this trial at
2
sites
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355 East Erie Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Arun Jayaraman, PT, Phd
Phone: 312-238-6875
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