Simulated Home Therapy Program for the Hand After Stroke

NCT ID: NCT02072369

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-12-31

Brief Summary

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

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

VAEDA Glove

Voice And EMG-Driven Actuated glove used during hand occupational therapy training

Group Type: EXPERIMENTAL

VAEDA Glove

Intervention Type: OTHER

Voice And EMG-Driven Actuated glove used during training

Occupational Therapy

Intervention Type: OTHER

novel upper extremity occupational therapy focused on the hand

No-glove

hand occupational therapy sessions without assistive device

Group Type: ACTIVE_COMPARATOR

Occupational Therapy

Intervention Type: OTHER

novel upper extremity occupational therapy focused on the hand

Interventions

VAEDA Glove

Voice And EMG-Driven Actuated glove used during training

Intervention Type: OTHER

Occupational Therapy

novel upper extremity occupational therapy focused on the hand

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Illinois Institute of Technology

OTHER

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Derek Kamper

Research Scientist, SMPP, RIC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derek G Kamper, PhD

Role: PRINCIPAL_INVESTIGATOR

Illinois Institute of Technology / Rehabilitation Institute of Chicago

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22275586 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19964456 (View on PubMed)

Other Identifiers

H133E070013, MARS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00032058

Identifier Type: -

Identifier Source: org_study_id