A Longitudinal Study of Function and Participation in Patients With Stroke

Study Overview
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Brief Summary
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A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis

Detailed Description
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Brain damage may lead to various motor deficits, which further influence the function and participation. Cerebral vascular accident (CVA) is the common disorder for acquired brain damage. Neural network in patients with brain damage could also be used to determine their clinical behavior by identifying altered neural network associated with behavioral improvement. The investigators hypothesize that the level of brain image and biomechanical will change with time in patients with stroke. Under this hypothesis, the measures of biomechanical change are correlated with neural changes. The aim of this study is to investigate the function and participation in patients with stroke evaluated by clinical measures, biomechanical, psychological, physiological and multimodal brain image. The primary goal of this study is to establish, evaluate and follow-up biomechanical- and image-based biomarkers for the impairment of function and participation information processing present in patients with stroke.

Official Title
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A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stroke Aged 20-80 years old Both ischemic stroke and hemorrhage Exclusion Criteria: Contraindication to MRI, such as metallic implant History of psychiatric disease Received Botulinum toxin (BTX-A) injection or surgery in recent six months Severe psychological impairments, such as mental retardation or severe Communication problems Progressive disorders, such as neurodegenerative disease Active medical disease, such as infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Control: Healthy adult | |
| Experimental<br>Experimental: patients with stroke | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months | Muscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months | fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI) | baseline, 6 months, 12 months | 
| Change from baseline of psychological in 6 months and 12 months | CANTAB touchscreen | baseline, 6 months, 12 months | 
| Change from baseline of body composition in 6 months and 12 months | InBody230 Body Composition Analyzer | baseline, 6 months, 12 months | 
| Change from baseline of severity in 6 months and 12 months | Brunnstrom stage classification, Modified Ashworth Scale and National Institute of Health Stroke Scale | baseline, 6 months, 12 months | 
| Change from baseline of body in 6 months and 12 months | Minimal Mental State Examination, Beck Depression Inventory-II, Fugl-Meyer assessment, Pediatric Berg Balance Scale, Action Research Arm Test and Box and Block Test | baseline, 6 months, 12 months | 
| Change from baseline of activity in 6 months and 12 months | Barthel Index, Wolf motor function test, Motor activity log, Walking test, Timed 'Up & Go' test and Functional Independence Measure | baseline, 6 months, 12 months | 
| Change from baseline of participation in 6 months and 12 months | Adaptive behavior assessment system and Nottingham Health Profile | baseline, 6 months, 12 months | 
| Change from baseline of quality of life in 6 months and 12 months | Stroke Impact Scale | baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, participation, brain imaging, biomechanical