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A Longitudinal Study of Function and Participation in Patients With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377453
Recruitment Status : Unknown
Verified September 2016 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : March 3, 2015
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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

Condition or disease
Stroke

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis
Study Start Date : April 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Group/Cohort
Control
Control: Healthy adult
Experimental
Experimental: patients with stroke



Primary Outcome Measures :
  1. Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Muscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis


Secondary Outcome Measures :
  1. Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)

  2. Change from baseline of psychological in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    CANTAB touchscreen

  3. Change from baseline of body composition in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    InBody230 Body Composition Analyzer

  4. Change from baseline of severity in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Brunnstrom stage classification, Modified Ashworth Scale and National Institute of Health Stroke Scale

  5. Change from baseline of body in 6 months and 12 months [ Time Frame: baseline, 6 months, 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

  6. Change from baseline of activity in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Barthel Index, Wolf motor function test, Motor activity log, Walking test, Timed 'Up & Go' test and Functional Independence Measure

  7. Change from baseline of participation in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Adaptive behavior assessment system and Nottingham Health Profile

  8. Change from baseline of quality of life in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Stroke Impact Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Control and experimental groups
Criteria

Inclusion Criteria:

  1. Patients with stroke
  2. Aged 20-80 years old
  3. Both ischemic stroke and hemorrhage

Exclusion Criteria:

  1. Contraindication to MRI, such as metallic implant
  2. History of psychiatric disease
  3. Received Botulinum toxin (BTX-A) injection or surgery in recent six months
  4. Severe psychological impairments, such as mental retardation or severe Communication problems
  5. Progressive disorders, such as neurodegenerative disease
  6. Active medical disease, such as infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377453


Contacts
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Contact: Chia-Ling Chen, MD, PhD +886-3-3281200 ext 8148 clingchen@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, MD, PhD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Principal Investigator: Chia-Ling Chen, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02377453    
Other Study ID Numbers: 102-5783B
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
stroke
participation
brain imaging
biomechanical
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases