A Longitudinal Study of Function and Participation in Patients With Stroke

• Conditions: Stroke

• Registration Number: NCT02377453
• Lead Sponsor: Chang Gung Memorial Hospital

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-05
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months	baseline, 6 months, 12 months	Muscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis

Secondary Outcome Measures

Name	Time	Method
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months	baseline, 6 months, 12 months	fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)
Change from baseline of body composition in 6 months and 12 months	baseline, 6 months, 12 months	InBody230 Body Composition Analyzer
Change from baseline of psychological in 6 months and 12 months	baseline, 6 months, 12 months	CANTAB touchscreen
Change from baseline of severity in 6 months and 12 months	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	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	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	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	baseline, 6 months, 12 months	Stroke Impact Scale

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan