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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: VAEDA Glove; Other: Occupational Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAEDA Glove; Voice And EMG-Driven Actuated glove used during hand occupational therapy training	Other: VAEDA Glove; Voice And EMG-Driven Actuated glove used during training; Other: Occupational Therapy; novel upper extremity occupational therapy focused on the hand
Active Comparator: No-glove; hand occupational therapy sessions without assistive device	Other: Occupational Therapy; novel upper extremity occupational therapy focused on the hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Action Research Arm Test (ARAT)	Change from Baseline after 6 weeks of training
Wolf Motor Function Test (WMFT)	Change from Baseline after 6 weeks of training
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)	Change from Baseline after 6 weeks of training
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)	Change from Baseline after 6 weeks of training
Action Research Arm Test (ARAT)	Change from Baseline to 1 month following training completion
Wolf Motor Function Test (WMFT)	Change from Baseline to 1 month following training completion
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)	Change from Baseline to 1 month following training completion
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)	Change from Baseline to 1 month following training completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Kinematics	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.	Change from Baseline after 6 weeks of training and 1 month follow up
3-point (palmar) Pinch Strength (PPS)	using a pinch gauge (PG-60, B&L Engineering)	Change from Baseline after 6 weeks of training and 1 month follow up
Lateral Pinch Strength (LPS)	using a pinch gauge (PG-60, B&L Engineering)	Change from Baseline after 6 weeks of training and 1 month follow up
Grip Strength (GS)	JAMAR 5030J1 Hand Dynamometer	Change from Baseline after 6 weeks of training and 1 month follow up

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: Illinois Institute of Technology
• Investigators: Principal Investigator: Derek G Kamper, PhD, Illinois Institute of Technology / Rehabilitation Institute of Chicago

Publications and helpful links

General Publications

• Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382.
• Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; training; hand; fingers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STU00032058; H133E070013, MARS (Other Grant/Funding Number: National Institute of Disability and Rehabilitation Research)

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: No