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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01883960
Date of registration:	10/06/2013
Prospective Registration:	No
Primary sponsor:	Chang Gung Memorial Hospital
Public title:	A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage
Scientific title:	A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies
Date of first enrolment:	September 2010
Target sample size:	150
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT01883960
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Taiwan

Contacts

Name:	Chia-Ling Chen, PhD
Address:
Telephone:
Email:
Affiliation:	Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. CP-patients with CP and aged 6-18 years

2. CVA-patients with stroke and aged 40-75 years

Exclusion Criteria:

1. contraindication to MRI

2. history of psychiatric disease

3. received BTX-A injection or surgery in recent six months

4. severe psychological impairments, such as mental retardation, autism or severe
communication problems

5. progressive disorders, such as neurodegenerative disease

6. active medical disease, such as infection

Age minimum: 6 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Cerebral Palsy

Intervention(s)

Primary Outcome(s)

Change from baseline of fMRI analysis in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Secondary Outcome(s)

Change from baseline of movement and participation for CP in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of severity for stroke patients in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of movement and participation for Healthy adults and stroke patients in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of movement and participation for stroke patients in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of severity for CP patients in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of Quality of life in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Change from baseline of kinematic analysis in 6 months and 12 months [Time Frame: baseline, 6 months, 12 months]

Secondary ID(s)

99-1732B

CMRPG391671

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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