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Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke

Primary Purpose

Cerebral Stroke, Cerebrovascular Accident, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotics training for shoulder elbow.
Surface Functional Neuromuscular Stimulation
whole arm motor learning
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke focused on measuring Motor Learning, Rehabilitation, Robotics, Therapeutic Electric Stimulation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Medically stable and at least 12 months post stroke. Difficulty using upper limb for functional tasks. Age >21 years Exclusion Criteria: uncontrolled, chronic medical condition

Sites / Locations

  • VA Medical Center, Cleveland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Wrist/Hand FES + Whole Arm Motor Learning

Shoulder/Elbow Robotics + Whole Arm Motor Learning

Whole Arm Motor Learning

Arm Description

Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning training and FES of the wrist/hand.

Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.

Subjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics

Outcomes

Primary Outcome Measures

AMAT
The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.
M1 Activation Absolute Change Score
A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2005
Last Updated
October 3, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00237744
Brief Title
Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke
Official Title
CNS Plasticity Induced By Motor Learning Technologies Following Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.
Detailed Description
Methods. Up to ninety-six chronic stroke subjects (> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Cerebrovascular Accident, Stroke
Keywords
Motor Learning, Rehabilitation, Robotics, Therapeutic Electric Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wrist/Hand FES + Whole Arm Motor Learning
Arm Type
Experimental
Arm Description
Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning training and FES of the wrist/hand.
Arm Title
Shoulder/Elbow Robotics + Whole Arm Motor Learning
Arm Type
Experimental
Arm Description
Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
Arm Title
Whole Arm Motor Learning
Arm Type
Experimental
Arm Description
Subjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics
Intervention Type
Device
Intervention Name(s)
Robotics training for shoulder elbow.
Intervention Description
training utilizing a robot to assist with movement practice
Intervention Type
Device
Intervention Name(s)
Surface Functional Neuromuscular Stimulation
Intervention Description
training utilizing FNS to assist with movement practice
Intervention Type
Other
Intervention Name(s)
whole arm motor learning
Intervention Description
intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
Primary Outcome Measure Information:
Title
AMAT
Description
The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.
Time Frame
prior to treatment and following 3 months of treatment
Title
M1 Activation Absolute Change Score
Description
A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.
Time Frame
at baseline and following 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Medically stable and at least 12 months post stroke. Difficulty using upper limb for functional tasks. Age >21 years Exclusion Criteria: uncontrolled, chronic medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis Daly, PhD MS
Organizational Affiliation
VA Medical Center, Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17391704
Citation
Fang Y, Yue GH, Hrovat K, Sahgal V, Daly JJ. Abnormal cognitive planning and movement smoothness control for a complex shoulder/elbow motor task in stroke survivors. J Neurol Sci. 2007 May 15;256(1-2):21-9. doi: 10.1016/j.jns.2007.01.078. Epub 2007 Mar 27.
Results Reference
background
PubMed Identifier
19362515
Citation
Fang Y, Daly JJ, Sun J, Hvorat K, Fredrickson E, Pundik S, Sahgal V, Yue GH. Functional corticomuscular connection during reaching is weakened following stroke. Clin Neurophysiol. 2009 May;120(5):994-1002. doi: 10.1016/j.clinph.2009.02.173. Epub 2009 Apr 10.
Results Reference
background
PubMed Identifier
24613940
Citation
Daly JJ, Hrovat K, Holcomb J, Pundik S. Brain control of functional reach in healthy adults and stroke survivors. Restor Neurol Neurosci. 2014;32(5):559-73. doi: 10.3233/RNN-130361.
Results Reference
background
PubMed Identifier
21343527
Citation
Kisiel-Sajewicz K, Fang Y, Hrovat K, Yue GH, Siemionow V, Sun CK, Jaskolska A, Jaskolski A, Sahgal V, Daly JJ. Weakening of synergist muscle coupling during reaching movement in stroke patients. Neurorehabil Neural Repair. 2011 May;25(4):359-68. doi: 10.1177/1545968310388665. Epub 2011 Feb 22.
Results Reference
background
PubMed Identifier
21839177
Citation
Wang XF, Jiang Z, Daly JJ, Yue GH. A generalized regression model for region of interest analysis of fMRI data. Neuroimage. 2012 Jan 2;59(1):502-10. doi: 10.1016/j.neuroimage.2011.07.079. Epub 2011 Jul 31.
Results Reference
background
PubMed Identifier
18786565
Citation
Daly JJ, Hrovat K, Pundik S, Sunshine J, Yue G. fMRI methods for proximal upper limb joint motor testing and identification of undesired mirror movement after stroke. J Neurosci Methods. 2008 Oct 30;175(1):133-42. doi: 10.1016/j.jneumeth.2008.07.025. Epub 2008 Aug 22.
Results Reference
background
PubMed Identifier
28683745
Citation
Philips GR, Daly JJ, Principe JC. Topographical measures of functional connectivity as biomarkers for post-stroke motor recovery. J Neuroeng Rehabil. 2017 Jul 6;14(1):67. doi: 10.1186/s12984-017-0277-3.
Results Reference
derived

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Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke

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