Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living
Primary Purpose
Hemiparesis, Ischemic Stroke, Chronic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Robot Therapy Device
Occupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring Robot Therapy, Upper Limb, Stroke, Rehabilitation, fMRI, DTI
Eligibility Criteria
Inclusion Criteria:
Stroke:
- 30 to 85 years
- Right-handed (evaluated with handedness survey)
- suffered a unilateral ischemic stroke in the motor control area, which resulted in hemiparesis of the arm (confirmed by medical data),
- at least 6-months post-stroke
- residual movement at least (a) 15 degree shoulder flexion or adduction, (b) 15 degree active elbow flexion and extension
- not claustrophobic
- not depressed (as measured depression survey)
- able to use the scanner, i.e., passes the fMRI screening survey
- able to understand the instructions and complete the tracking tasks Control
- older than 20 years
- Right-handed (evaluated with survey)
- not claustrophobic
- able to use the scanner, i.e., passes the fMRI screening survey
- able to understand the instructions and complete the tracking tasks
- no history of neurological disorders --not depressed (as measured depression survey)
Exclusion Criteria:
Stroke:
- brain stem, stroke
- pre-existing neurological or psychiatric disorders
- Spasticity >3 at elbow or fingers on Ashworth
- demonstrated visuospatial, language or attention deficits of a severity that prevents understanding the task
- shoulder pain or joint pain during movements
- synkinetic movements or mirror movements
- decline to participate
- will not comply with full protocol
- pregnant
- allergic to goretex and conductivity gel
Control
- decline to participate
- will not comply with full protocol
- pregnant
- allergic to goretex and conductivity gel
Sites / Locations
- Medical College of Wisconsin
- Clement J Zablocki VA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Robot Therapy with activities of daily living (ADLs)
Standard Occupational Therapy
Outcomes
Primary Outcome Measures
Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor
Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness
Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index
Secondary Outcome Measures
Clinical Measures: Joint ROM, MMT, Spasticity
Clinical Measures: Pain, Exertion
Full Information
NCT ID
NCT00878085
First Posted
March 23, 2009
Last Updated
February 3, 2014
Sponsor
Medical College of Wisconsin
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), US Department of Veterans Affairs, Marquette University
1. Study Identification
Unique Protocol Identification Number
NCT00878085
Brief Title
Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living
Official Title
fMRI and Robot-Assisted Practice of Activities of Daily Living
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), US Department of Veterans Affairs, Marquette University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will study motor recovery after robot-assisted therapy after stroke. A small clinical trial will be conducted to quantify the central nervous system changes associated with robotic or standard training, and identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity.The investigators hypothesize that robot training will lead to larger improvements as compared to standard occupational therapy. The investigators hypothesize that high responders to the robot training will have reduced compensatory activation in the bilateral area and will connectivity in the motor tracts.
Detailed Description
Robot-assisted therapy is on the cutting edge of stroke rehabilitation and is a therapy method that promises to improve the lives of persons with disabilities due to stroke. Preliminary studies using these tools provide mixed evidence for their effectiveness and reveal limitations. For example, inconsistent carryover of motor gains to real life activities of daily living (ADLs) is seen. Therefore, it is still not clear what treatment strategies maximize functional outcomes on ADLs. There is a need to study the stroke recovery process and to understand how to optimize robot-assisted therapies in order to enhance patient rehabilitation and improve functional outcomes. Imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI) can assist us in understanding the stroke recovery process, in determining who may benefit from robot-assisted training, and in defining how training induced functional cortical changes occur after robot training. We propose to conduct an interventional study plus control to assess the effectiveness of four weeks of robot-assisted practice of tasks with skilled functional tasks that involve reaching and grasping activities similar to real activities. We will examine the process of recovery for low-to-moderate functioning stroke survivors with chronic disability. We will assess the ability of active-assisted reaching and grasping training to effect immediate gains and long-term functional improvements. Further, using fMRI and DTI, we plan to associate changes seen in motor impairment levels and functional task performance levels with white matter injuries and connectivity and changes in oxygen utilization in the motor cortex as well as other areas of the brain. Our short-term aims are to, i) assess short-term functional gains after practice of skilled reaching and grasping tasks; ii) assess maintenance of these improvements; iii) quantify the neuronal changes associated with short-term gains, and iv) identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity. In the long-term, we hope to improve understanding of the process of ADL functional recovery after stroke and optimize robot-training strategies leading to cerebral plasticity. We also hope to determine how lesion characteristics affect changes seen in function, white matter connectivity, and cortical activity. By, accomplishing these aims, we hope to improve upper extremity function after stroke and reduce disability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Ischemic Stroke, Chronic
Keywords
Robot Therapy, Upper Limb, Stroke, Rehabilitation, fMRI, DTI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Robot Therapy with activities of daily living (ADLs)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard Occupational Therapy
Intervention Type
Device
Intervention Name(s)
Robot Therapy Device
Intervention Description
3x a week for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Intervention Description
3x a week for 4 weeks
Primary Outcome Measure Information:
Title
Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor
Time Frame
Pre (2x) , Post, Follow-Up
Title
Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness
Time Frame
Pre (2x), Post, Follow-up
Title
Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index
Time Frame
Pre (1x), Post, Follow-up
Secondary Outcome Measure Information:
Title
Clinical Measures: Joint ROM, MMT, Spasticity
Time Frame
Pre(2x), Post, Follow-up
Title
Clinical Measures: Pain, Exertion
Time Frame
During Therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stroke:
30 to 85 years
Right-handed (evaluated with handedness survey)
suffered a unilateral ischemic stroke in the motor control area, which resulted in hemiparesis of the arm (confirmed by medical data),
at least 6-months post-stroke
residual movement at least (a) 15 degree shoulder flexion or adduction, (b) 15 degree active elbow flexion and extension
not claustrophobic
not depressed (as measured depression survey)
able to use the scanner, i.e., passes the fMRI screening survey
able to understand the instructions and complete the tracking tasks Control
older than 20 years
Right-handed (evaluated with survey)
not claustrophobic
able to use the scanner, i.e., passes the fMRI screening survey
able to understand the instructions and complete the tracking tasks
no history of neurological disorders --not depressed (as measured depression survey)
Exclusion Criteria:
Stroke:
brain stem, stroke
pre-existing neurological or psychiatric disorders
Spasticity >3 at elbow or fingers on Ashworth
demonstrated visuospatial, language or attention deficits of a severity that prevents understanding the task
shoulder pain or joint pain during movements
synkinetic movements or mirror movements
decline to participate
will not comply with full protocol
pregnant
allergic to goretex and conductivity gel
Control
decline to participate
will not comply with full protocol
pregnant
allergic to goretex and conductivity gel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Torbey, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Chair
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Clement J Zablocki VA
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
12. IPD Sharing Statement
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Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living
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