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A Longitudinal Study of Function and Participation in Patients With Stroke

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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

Tracking Information
First Submitted Date February 25, 2015
First Posted Date March 3, 2015
Last Update Posted Date October 5, 2016
Study Start Date April 2014
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 2, 2015)
  • 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)
  • Change from baseline of psychological in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    CANTAB touchscreen
  • Change from baseline of body composition in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    InBody230 Body Composition Analyzer
  • 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
  • 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
  • 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
  • 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
  • Change from baseline of quality of life in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ]
    Stroke Impact Scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Longitudinal Study of Function and Participation in Patients With Stroke
Official Title A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis
Brief Summary A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Control and experimental groups
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts
  • Control
    Control: Healthy adult
  • Experimental
    Experimental: patients with stroke
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 2, 2015)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02377453
Other Study ID Numbers 102-5783B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators
Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date September 2016