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Completed

NCT Number: NCT02072369

Simulated Home Therapy Program for the Hand After Stroke

The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

About this study

Stroke survivors with chronic hemiparesis of the upper extremity undertook 18 one-hour training sessions over a 6-week period. Participants received occupational therapy focusing on grasp-and-release using a task-oriented protocol developed at the Rehabilitation Institute of Chicago by Dr. Mary Ellen Stoykov. Over 90% of all repetitions performed during each session were focused on functional activities, as opposed to active exercise. The skills and strategies developed in therapy were then implemented into activities identified as goals by the participant, such as donning socks. Difficulty of the task, activity, or exercise was progressed for each participant to provide optimal challenge to enhance skill.

Subjects were assigned to one of two groups by casting lots. One group (VAEDA Glove) performed all tasks while wearing a custom Voice And EMG-Driven Actuated glove, the VAEDA Glove. The other group (No-Glove) performed the same types of tasks without use of the VAEDA Glove. The VAEDA Glove is a portable active-assistance glove, designed to assist digit extension in order to allow repeated practice of specified tasks. The glove contains cables traversing the dorsal side of the digits in order to provide extension and resist flexion. Forces are transmitted through the cables from a servomotor located remotely to the digits. The servomotor controls torque or displacement in the cable. Along the digits, the cables traverse through custom plastic blocks, which serve both to guide the cable and to prevent joint hyperextension.

The VAEDA Glove can be controlled with up to 3 channels of electromyography (EMG). For this study, electrodes were placed above flexor digitorum superficialis (FDS) and extensor digitorum communis (EDC). The group using the J-Glove could receive assistance during hand opening, but only if appropriate EMG activity was detected. The EDC EMG activity had to reach a prescribed threshold before extension assistance would be provided. Similarly, FDS EMG activity had to surpass a threshold level during hand closing before the user was allowed to flex the digits. Feedback of muscle activity was available to the user through a custom graphical user interface.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke)
  • moderate hand impairment classified as Stage 4 on the Chedoke McMaster Stroke Assessment

Exclusion criteria

  • anti-spasticity medications/injections taken less than 6 month prior to enrollment
  • contractures greater than 20 degrees
  • inability to follow single-step commands
  • significant upper extremity pain (self-reported pain of greater than 6 on a 10-point scale)

Treatment and study plan

VAEDA Glove

Other

Voice And EMG-Driven Actuated glove used during training

Occupational Therapy

Other

novel upper extremity occupational therapy focused on the hand

Primary outcomes

  1. The Action Research Arm Test (ARAT)

    Time frame: Change from Baseline after 6 weeks of training

  2. Wolf Motor Function Test (WMFT)

    Time frame: Change from Baseline after 6 weeks of training

  3. Fugl-Meyer Upper Extremity Motor Assessment (FMUE)

    Time frame: Change from Baseline after 6 weeks of training

  4. Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)

    Time frame: Change from Baseline after 6 weeks of training

  5. Action Research Arm Test (ARAT)

    Time frame: Change from Baseline to 1 month following training completion

  6. Wolf Motor Function Test (WMFT)

    Time frame: Change from Baseline to 1 month following training completion

  7. Fugl-Meyer Upper Extremity Motor Assessment (FMUE)

    Time frame: Change from Baseline to 1 month following training completion

  8. Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)

    Time frame: Change from Baseline to 1 month following training completion

Secondary outcomes

  1. Hand Kinematics

    Time frame: Change from Baseline after 6 weeks of training and 1 month follow up

    hand kinematics were measured explicitly with a CyberGlove (CyberGlove Systems LLC, San Jose, CA). From an initially relaxed, resting posture, participants were asked to extend the digits fully ("open") and then flex fully ("close") their affected hand into a fist. The CyberGlove measured joint displacement for each digit during task performance.

  2. 3-point (palmar) Pinch Strength (PPS)

    Time frame: Change from Baseline after 6 weeks of training and 1 month follow up

    using a pinch gauge (PG-60, B&L Engineering)

  3. Lateral Pinch Strength (LPS)

    Time frame: Change from Baseline after 6 weeks of training and 1 month follow up

    using a pinch gauge (PG-60, B&L Engineering)

  4. Grip Strength (GS)

    Time frame: Change from Baseline after 6 weeks of training and 1 month follow up

    JAMAR 5030J1 Hand Dynamometer

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Illinois Institute of Technology

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 26, 2014
Registry last updated
Jun 27, 2017

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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