Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 5:23 AM
Study NCT ID:
NCT03264235
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: