Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion

February 5, 2021 updated by: Allison Okamura, Stanford University

Effects of Post-Stroke Upper Extremity Assistance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University CHARM Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke survivors
Stroke survivors with upper extremity motor impairments
Device: compliant support
Participants will be given compliant arm support and their reachable workspace measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Reachable Workspace
Time Frame: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Biceps Activation
Time Frame: baseline and while using support device (up to 10 seconds per assessment)
Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies.
baseline and while using support device (up to 10 seconds per assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Allison Okamura, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2019

Primary Completion (Actual)

April 27, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-49194
  • SNI-BI1-02 (Other Grant/Funding Number: Stanford Neurosciences Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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