Back to resultsEffects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion
Primary Purpose
Arm Weakness as a Consequence of Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
compliant support
Sponsored by
About this trial
This is an interventional supportive care trial for Arm Weakness as a Consequence of Stroke
Eligibility Criteria
Inclusion Criteria:
- greater than 6 months post-stroke
- passive abduction to 90 degrees at shoulder
- reduced active (retro)flexion/extension at shoulder when abducted to 90 degrees
- reduced active flexion/extension at elbow
Exclusion Criteria:
- unable to give informed consent
- unable to comprehend and follow instructions
- have a condition (other than stroke) affecting sensorimotor function
- show evidence of unilateral spatial neglect
- unable to sit in a chair without armrests for 2 hours
Sites / Locations
- Stanford University CHARM Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stroke survivors
Arm Description
Stroke survivors with upper extremity motor impairments
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Reachable Workspace
Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
Secondary Outcome Measures
Percent Change From Baseline in Biceps Activation
Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03867838
Brief Title
Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion
Official Title
Effects of Post-Stroke Upper Extremity Assistance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
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
No
5. Study Description
Brief Summary
The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Weakness as a Consequence of Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke survivors
Arm Type
Experimental
Arm Description
Stroke survivors with upper extremity motor impairments
Intervention Type
Device
Intervention Name(s)
compliant support
Intervention Description
Participants will be given compliant arm support and their reachable workspace measured
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Reachable Workspace
Description
Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
Time Frame
baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Biceps Activation
Description
Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies.
Time Frame
baseline and while using support device (up to 10 seconds per assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
greater than 6 months post-stroke
passive abduction to 90 degrees at shoulder
reduced active (retro)flexion/extension at shoulder when abducted to 90 degrees
reduced active flexion/extension at elbow
Exclusion Criteria:
unable to give informed consent
unable to comprehend and follow instructions
have a condition (other than stroke) affecting sensorimotor function
show evidence of unilateral spatial neglect
unable to sit in a chair without armrests for 2 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Okamura
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University CHARM Lab
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Simpson CS, Okamura AM, and Hawkes EW. Exomuscle: An inflatable device for shoulder abduction support. 2017 IEEE International Conference on Robotics and Automation (ICRA) 2017; pp. 6651-6657.
Results Reference
background
Citation
Simpson C, Huerta B, Sketch S, Lansberg M, Hawkes E, and Okamura A. Upper Extremity Exomuscle for Shoulder Abduction Support. IEEE Transactions on Medical Robotics and Bionics. 2020; 2(3):474-484.
Results Reference
result
Learn more about this trial
Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion
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