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

Arm Weakness as a Consequence of Stroke Clinical Trial

Official title:

Effects of Post-Stroke Upper Extremity Assistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867838
• Other study ID #: IRB-49194
• Secondary ID: SNI-BI1-02
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 1, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arm Weakness as a Consequence of Stroke
• Stroke

Intervention

Device:
• compliant support
Participants will be given compliant arm support and their reachable workspace measured

Locations

Country	Name	City	State
United States	Stanford University CHARM Lab	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline and while using support device (up to 10 seconds per assessment)