A Longitudinal Study of Function and Participation in Patients With Stroke
1 other identifier
observational
300
1 country
1
Brief Summary
A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedOctober 5, 2016
September 1, 2016
2.8 years
February 25, 2015
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
baseline, 6 months, 12 months
Change from baseline of psychological in 6 months and 12 months
baseline, 6 months, 12 months
Change from baseline of body composition in 6 months and 12 months
baseline, 6 months, 12 months
Change from baseline of severity in 6 months and 12 months
baseline, 6 months, 12 months
Change from baseline of body in 6 months and 12 months
baseline, 6 months, 12 months
- +3 more secondary outcomes
Study Arms (2)
Control
Control: Healthy adult
Experimental
Experimental: patients with stroke
Eligibility Criteria
Control and experimental groups
You may qualify if:
- Patients with stroke
- Aged 20-80 years old
- Both ischemic stroke and hemorrhage
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chia-Ling Chen, MD, PhD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
April 1, 2014
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
October 5, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share