Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01367327 |
Date of registration:
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09/08/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
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Scientific title:
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Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia |
Date of first enrolment:
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January 2009 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01367327 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Hua-Fang Liao, MS |
Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Physical Therapy, National Taiwan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- children with SD, aged 5 to 13 year-old, and GMFCS level between I to III
- able to stand up from a chair independently and maintain standing for more than 2
seconds without falling
- able to follow verbal instructions
Exclusion Criteria:
- have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within
6 months
- have orthopedic problems or other medical conditions preventing the child from
joining the resistance exercise program, such as obvious LE joint contractures,
uncontrolled epilepsy, or cardiopulmonary problems
- hearing loss or using hearing aid
- have mental disorders, such as pervasive developmental disorders and
attention-deficit and disruptive behavior disorders
Age minimum:
5 Years
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy
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Paraparesis, Spastic
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Intervention(s)
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Behavioral: Synchronized music
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Behavioral: Loaded sit-to-stand exercise
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Primary Outcome(s)
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Gross Motor Function Measure
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Pediatric Evaluation of Disability Inventory
[Time Frame: 12 weeks]
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One-repetition maximum of loaded sit-to-stand test
[Time Frame: 12 weeks]
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Intrinsic Motivation Inventory-Chinese Version
[Time Frame: 12 weeks]
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Exercise Adherence and Volume
[Time Frame: 12 weeks]
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Motor Control Variables of the STS Movement
[Time Frame: 12 weeks]
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Secondary ID(s)
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0971762466
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98-2314-B-002-011-MY3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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