Back to resultsAnkle Exosuit Training in the Clinic to Community Community
Primary Purpose
Stroke
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill walking
Overground Walking
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring exoskeleton, ambulation, robotics, Stroke, walking
Eligibility Criteria
Inclusion Criteria:
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm, inclusive
- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
- Medical clearance by a physician
Exclusion Criteria:
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
- History of significant Peripheral Artery Disease (PAD)
- Unresolved Deep Vein Thrombosis (DVT)
- Uncontrolled or untreated hypertension
- Significant paretic ankle contractures (plantarflexion > 5°)
- Psychiatric or cognitive impairments that may interfere with proper operation of the device
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ReWalk Soft Exosuit
Arm Description
During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol.
Outcomes
Primary Outcome Measures
Change in 10 Meter Walk Test from baseline gait speed
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
Secondary Outcome Measures
Change in 6 Minute Walk Test in distance from baseline
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.
Functional Gait Assessment (FGA)
The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.
Full Information
NCT ID
NCT04251091
First Posted
January 29, 2020
Last Updated
January 12, 2023
Sponsor
Arun Jayaraman, PT, PhD
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT04251091
Brief Title
Ankle Exosuit Training in the Clinic to Community Community
Official Title
Ankle Exosuit Training in the Clinic to Community
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arun Jayaraman, PT, PhD
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
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
exoskeleton, ambulation, robotics, Stroke, walking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Previous work has demonstrated that the tuning of the exosuit technology is important for each patient post stroke to be able to maximally utilize the technology. These modulations include when the plantarflexion force is delivered, and how to deliver the assistance within a training session however it is still unclear how to implement this into a training protocol. During a part of this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out a training protocol
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ReWalk Soft Exosuit
Arm Type
Experimental
Arm Description
During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol.
Intervention Type
Other
Intervention Name(s)
Treadmill walking
Intervention Description
Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets
Intervention Type
Other
Intervention Name(s)
Overground Walking
Intervention Description
Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets
Primary Outcome Measure Information:
Title
Change in 10 Meter Walk Test from baseline gait speed
Description
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
Time Frame
Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Secondary Outcome Measure Information:
Title
Change in 6 Minute Walk Test in distance from baseline
Description
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.
Time Frame
Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Title
Functional Gait Assessment (FGA)
Description
The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.
Time Frame
Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 - 80 years old
Stroke event occurred at least 6 months ago
Observable gait deficits
Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
Resting heart rate between 40 - 100 bpm, inclusive
Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
Medical clearance by a physician
Exclusion Criteria:
Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
Inability to communicate with investigators
Neglect or hemianopia
Unexplained dizziness in the last 6 months
Pressure ulcers or skin wounds located at human-device interface sites
History of significant Peripheral Artery Disease (PAD)
Unresolved Deep Vein Thrombosis (DVT)
Uncontrolled or untreated hypertension
Significant paretic ankle contractures (plantarflexion > 5°)
Psychiatric or cognitive impairments that may interfere with proper operation of the device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35655180
Citation
Shin SY, Hohl K, Giffhorn M, Awad LN, Walsh CJ, Jayaraman A. Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study. J Neuroeng Rehabil. 2022 Jun 3;19(1):51. doi: 10.1186/s12984-022-01034-2. Erratum In: J Neuroeng Rehabil. 2022 Sep 19;19(1):100.
Results Reference
derived
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Ankle Exosuit Training in the Clinic to Community Community
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