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Simulated Home Therapy Program for the Hand After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VAEDA Glove
Occupational Therapy
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring stroke, hand, fingers, rehabilitation, training

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VAEDA Glove

No-glove

Arm Description

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

hand occupational therapy sessions without assistive device

Outcomes

Primary Outcome Measures

The Action Research Arm Test (ARAT)
Wolf Motor Function Test (WMFT)
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Action Research Arm Test (ARAT)
Wolf Motor Function Test (WMFT)
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)

Secondary Outcome Measures

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.
3-point (palmar) Pinch Strength (PPS)
using a pinch gauge (PG-60, B&L Engineering)
Lateral Pinch Strength (LPS)
using a pinch gauge (PG-60, B&L Engineering)
Grip Strength (GS)
JAMAR 5030J1 Hand Dynamometer

Full Information

First Posted
February 20, 2014
Last Updated
June 26, 2017
Sponsor
Shirley Ryan AbilityLab
Collaborators
Illinois Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02072369
Brief Title
Simulated Home Therapy Program for the Hand After Stroke
Official Title
Simulated Home Therapy Program for the Hand After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Illinois Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, hand, fingers, rehabilitation, training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAEDA Glove
Arm Type
Experimental
Arm Description
Voice And EMG-Driven Actuated glove used during hand occupational therapy training
Arm Title
No-glove
Arm Type
Active Comparator
Arm Description
hand occupational therapy sessions without assistive device
Intervention Type
Other
Intervention Name(s)
VAEDA Glove
Intervention Description
Voice And EMG-Driven Actuated glove used during training
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Intervention Description
novel upper extremity occupational therapy focused on the hand
Primary Outcome Measure Information:
Title
The Action Research Arm Test (ARAT)
Time Frame
Change from Baseline after 6 weeks of training
Title
Wolf Motor Function Test (WMFT)
Time Frame
Change from Baseline after 6 weeks of training
Title
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Time Frame
Change from Baseline after 6 weeks of training
Title
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Time Frame
Change from Baseline after 6 weeks of training
Title
Action Research Arm Test (ARAT)
Time Frame
Change from Baseline to 1 month following training completion
Title
Wolf Motor Function Test (WMFT)
Time Frame
Change from Baseline to 1 month following training completion
Title
Fugl-Meyer Upper Extremity Motor Assessment (FMUE)
Time Frame
Change from Baseline to 1 month following training completion
Title
Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)
Time Frame
Change from Baseline to 1 month following training completion
Secondary Outcome Measure Information:
Title
Hand Kinematics
Description
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.
Time Frame
Change from Baseline after 6 weeks of training and 1 month follow up
Title
3-point (palmar) Pinch Strength (PPS)
Description
using a pinch gauge (PG-60, B&L Engineering)
Time Frame
Change from Baseline after 6 weeks of training and 1 month follow up
Title
Lateral Pinch Strength (LPS)
Description
using a pinch gauge (PG-60, B&L Engineering)
Time Frame
Change from Baseline after 6 weeks of training and 1 month follow up
Title
Grip Strength (GS)
Description
JAMAR 5030J1 Hand Dynamometer
Time Frame
Change from Baseline after 6 weeks of training and 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek G Kamper, PhD
Organizational Affiliation
Illinois Institute of Technology / Rehabilitation Institute of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22275586
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.
Results Reference
background
PubMed Identifier
19964456
Citation
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.
Results Reference
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Simulated Home Therapy Program for the Hand After Stroke

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