A Longitudinal Study of Function and Participation in Patients With Stroke

NCT ID: NCT02377453

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-03-31

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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Control: Healthy adult

No interventions assigned to this group

Experimental

Experimental: patients with stroke

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ling Chen, MD, PhD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chia-Ling Chen, MD, PhD

Role: CONTACT

+886-3-3281200 ext. 8148

Facility Contacts

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Chia-Ling Chen, MD, PhD

Role: primary

+886-3-3281200 ext. 8147

Other Identifiers

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102-5783B

Identifier Type: -

Identifier Source: org_study_id

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