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The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA

Primary Purpose

Stroke, Acute, Gait Disorders, Neurologic

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Keeogo
Traditional Stair Training
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Powered-Knee Exoskeleton, Stair Training, Keeogo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan Ability Lab
  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 Exoskeleton

Group 2 Traditional Therapy

Arm Description

Both training groups will undergo inpatient physical therapy of the same duration and intensity. Group 1 will complete stair training wearing the Keeogo Exoskeleton in inpatient physical therapy.

Group 2 will complete traditional stair training in inpatient physical therapy.

Outcomes

Primary Outcome Measures

Change in Timed Stair Climb Test speed from baseline
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 Outcome Measures

5-times Sit to Stand Test
Method: Use a straight back chair with a solid seat that is 16" high. Ask participant to sit on the chair with arms folded across their chest. Instructions: "Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest." Measurement: Stop timing when the participant stands the 5th time.
GAITRite Data Collection
The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration.

Full Information

First Posted
August 9, 2017
Last Updated
October 24, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT03264235
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
U.S. Department of Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Gait Disorders, Neurologic
Keywords
Powered-Knee Exoskeleton, Stair Training, Keeogo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Exoskeleton
Arm Type
Experimental
Arm Description
Both training groups will undergo inpatient physical therapy of the same duration and intensity. Group 1 will complete stair training wearing the Keeogo Exoskeleton in inpatient physical therapy.
Arm Title
Group 2 Traditional Therapy
Arm Type
Active Comparator
Arm Description
Group 2 will complete traditional stair training in inpatient physical therapy.
Intervention Type
Device
Intervention Name(s)
Keeogo
Intervention Description
Keeogo is a computer-controlled lower extremity motorized orthosis worn over the user's hips and legs. The controller box contains sensors that supply information about the kinematics and the kinetics of the user's lower extremities and includes software that recognizes the user's mobility intentions. The system is powered by a lithium-polymer battery. The leg brace assembly is mainly comprised of the actuator, the electronic boards, hip joint, and soft goods (cuffs, belts) for affixing the assembly to the user's legs. The waist belt comes in various sizes adapted to each wearer, and adds additional support of the device on the user. Keeogo does not initiate any movement but waits for the user's lead. Once the user makes the first move, Keeogo assists according to the activity. The individual must be able to initiate and terminate steps.
Intervention Type
Other
Intervention Name(s)
Traditional Stair Training
Intervention Description
Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.
Primary Outcome Measure Information:
Title
Change in Timed Stair Climb Test speed from baseline
Description
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.
Time Frame
Initial Visit (Week 1); Post testing (Week 2)
Secondary Outcome Measure Information:
Title
5-times Sit to Stand Test
Description
Method: Use a straight back chair with a solid seat that is 16" high. Ask participant to sit on the chair with arms folded across their chest. Instructions: "Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest." Measurement: Stop timing when the participant stands the 5th time.
Time Frame
Initial Visit (Week 1); Post testing (Week 2)
Title
GAITRite Data Collection
Description
The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration.
Time Frame
Initial Visit (Week 1); Post testing (Week 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD
Organizational Affiliation
Shirley Ryan Ability Lab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan Ability Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA

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