Simulated Home Therapy Program for the Hand After Stroke

Stroke Clinical Trial

Official title:

Simulated Home Therapy Program for the Hand After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072369
• Other study ID #: STU00032058
• Secondary ID: H133E070013, MAR
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: June 26, 2017
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2017
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• VAEDA Glove
Voice And EMG-Driven Actuated glove used during training
• Occupational Therapy
novel upper extremity occupational therapy focused on the hand

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Illinois Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Action Research Arm Test (ARAT)		Change from Baseline after 6 weeks of training
Primary	Wolf Motor Function Test (WMFT)		Change from Baseline after 6 weeks of training
Primary	Fugl-Meyer Upper Extremity Motor Assessment (FMUE)		Change from Baseline after 6 weeks of training
Primary	Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)		Change from Baseline after 6 weeks of training
Primary	Action Research Arm Test (ARAT)		Change from Baseline to 1 month following training completion
Primary	Wolf Motor Function Test (WMFT)		Change from Baseline to 1 month following training completion
Primary	Fugl-Meyer Upper Extremity Motor Assessment (FMUE)		Change from Baseline to 1 month following training completion
Primary	Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)		Change from Baseline to 1 month following training completion
Secondary	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
Secondary	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
Secondary	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
Secondary	Grip Strength (GS)	JAMAR 5030J1 Hand Dynamometer	Change from Baseline after 6 weeks of training and 1 month follow up