Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living
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First Received Date ICMJE | March 23, 2009 | ||||
Last Updated Date | October 20, 2010 | ||||
Start Date ICMJE | November 2008 | ||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00878085 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living | ||||
Official Title ICMJE | fMRI and Robot-Assisted Practice of Activities of Daily Living | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 61 | ||||
Estimated Completion Date | June 2013 | ||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Stroke:
Exclusion Criteria: Stroke:
Control
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Gender | Both | ||||
Ages | 30 Years to 85 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878085 | ||||
Other Study ID Numbers ICMJE | HR, NIH 1K25NS058577 - 01A1 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Michelle J Johnson, PhD, Medical College of Wisconsin | ||||
Study Sponsor ICMJE | Medical College of Wisconsin | ||||
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Investigators ICMJE |
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Information Provided By | Medical College of Wisconsin | ||||
Verification Date | October 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |