Simulated Home Therapy Program for the Hand After Stroke

Completed

Phase N/A Results N/A

Trial Description

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

Detailed Description

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.

Conditions

Interventions

  • Occupational therapy Other
    Intervention Desc: novel upper extremity occupational therapy focused on the hand
    ARM 1: Kind: Experimental
    Label: J-glove
    Description: EMG-actuated glove used during hand occupational therapy training
    ARM 2: Kind: Experimental
    Label: No-glove
    Description: hand occupational therapy sessions without assistive device
    ARM 3: Kind: Experimental
    Label: VAEDA Glove
    Description: Voice And EMG-Driven Actuated glove used during hand occupational therapy training
  • J-glove Device
    Intervention Desc: EMG-actuated glove used during training
    ARM 1: Kind: Experimental
    Label: J-glove
    Description: EMG-actuated glove used during hand occupational therapy training
  • VAEDA Glove Other
    Intervention Desc: Voice And EMG-Driven Actuated glove used during training
    ARM 1: Kind: Experimental
    Label: VAEDA Glove
    Description: Voice And EMG-Driven Actuated glove used during hand occupational therapy training

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The Action Research Arm Test (ARAT) Change from Baseline after 6 weeks of training No
Primary Wolf Motor Function Test (WMFT) Change from Baseline after 6 weeks of training No
Primary 3-point (palmar) Pinch Strength (PPS) Change from Baseline after 6 weeks of training No
Primary Lateral Pinch Strength (LPS) Change from Baseline after 6 weeks of training No
Primary Grip Strength (GS) Change from Baseline after 6 weeks of training No
Primary Action Research Arm Test (ARAT) Change from Baseline to 1 month following training completion No
Secondary Hand Kinematics Change from Baseline after 6 weeks of training and 1 month follow up No
Primary Fugl-Meyer Upper Extremity Motor Assessment (FMUE) Change from Baseline after 6 weeks of training No
Primary Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H) Change from Baseline after 6 weeks of training No

Sponsors