Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion
Effects of Post-Stroke Upper Extremity Assistance
2 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedStudy Start
First participant enrolled
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedResults Posted
Study results publicly available
February 23, 2021
CompletedFebruary 23, 2021
February 1, 2021
11 months
March 5, 2019
November 9, 2020
February 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Reachable Workspace
Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
Secondary Outcomes (1)
Percent Change From Baseline in Biceps Activation
baseline and while using support device (up to 10 seconds per assessment)
Study Arms (1)
Stroke survivors
EXPERIMENTALStroke survivors with upper extremity motor impairments
Interventions
Participants will be given compliant arm support and their reachable workspace measured
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University CHARM Lab
Stanford, California, 94305, United States
Related Publications (2)
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.
BACKGROUNDSimpson 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.
RESULT
Results Point of Contact
- Title
- Cole Simpson
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Okamura
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Mechanical Engineering
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 8, 2019
Study Start
June 14, 2019
Primary Completion
April 27, 2020
Study Completion
October 1, 2020
Last Updated
February 23, 2021
Results First Posted
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share