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OpenTrials
Completed

NCT Number: NCT03867838

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

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.

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Key information

Conditions

Arm Weakness as a Consequence of Stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University CHARM Lab

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

compliant support

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effects of Post-Stroke Upper Extremity Assistance

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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