Back to resultsSPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke
Primary Purpose
Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exoskeleton
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Soft Robotics, Robotic Exoskeleton, Neurologic Rehabilitation, Physical Medicine and Rehabilitation, Rehabilitation Exercise
Eligibility Criteria
Inclusion Criteria:
- Adult Veterans with a stroke 1-6 months ago
- Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4)
Exclusion Criteria:
- Inability to follow 2-step commands
- Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5)
- Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
Sites / Locations
- Ralph H. Johnson VA Medical Center, Charleston, SC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
All participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.
Outcomes
Primary Outcome Measures
change in finger joint torque assistance
Change in finger joint torque assistance needed from the 1st half to the 2nd half of the 1-hour training session. Reduction in torque is considered a good outcome. There is no predefined minimum/maximum.
Secondary Outcome Measures
Full Information
NCT ID
NCT04978467
First Posted
July 16, 2021
Last Updated
June 27, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04978467
Brief Title
SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke
Official Title
Feasibility of Using Maestro Hand Exoskeleton in Post-stroke Hand Rehabilitation to Improve Joint Coordination
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The research team will develop a novel training tool to improve finger joint coordination, to address the unmet need in the current rehabilitation, thereby enhancing hand function and contributing to improved independence and quality of life for Veterans with stroke.
Detailed Description
The research team will determine feasibility of training using CA and TA controllers in subacute stroke. Specifically, we will examine if joint coordination improves over a training session. The investigators will compare the extent of improvement for each controller and impairment severity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Soft Robotics, Robotic Exoskeleton, Neurologic Rehabilitation, Physical Medicine and Rehabilitation, Rehabilitation Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will experience all controller conditions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
All participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.
Intervention Type
Device
Intervention Name(s)
Exoskeleton
Intervention Description
Participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.
Primary Outcome Measure Information:
Title
change in finger joint torque assistance
Description
Change in finger joint torque assistance needed from the 1st half to the 2nd half of the 1-hour training session. Reduction in torque is considered a good outcome. There is no predefined minimum/maximum.
Time Frame
from the 1st half to the 2nd half of the 1-hour training session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Veterans with a stroke 1-6 months ago
Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4)
Exclusion Criteria:
Inability to follow 2-step commands
Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5)
Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rutha A LaRue
Phone
(843) 789-6707
Email
Rutha.Larue@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD MS BS
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Vermillion
Phone
843-789-6710
Email
Richard.Vermillion@va.gov
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD MS BS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Due to the small sample size, individual data that are de-identified will be presented in publications.
IPD Sharing Time Frame
De-identified individual data that are presented in publications will be available as long as the publications are available.
IPD Sharing Access Criteria
Journals' access criteria.
Learn more about this trial
SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke
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