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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01367327
Date of registration: 09/08/2010
Prospective Registration: No
Primary sponsor: National Taiwan University Hospital
Public title: Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Scientific title: Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Date of first enrolment: January 2009
Target sample size: 36
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01367327
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Hua-Fang Liao, MS
Address: 
Telephone:
Email:
Affiliation:  Institute of Physical Therapy, National Taiwan University
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Cerebral Palsy
Paraparesis, Spastic
Intervention(s)
Behavioral: Synchronized music
Behavioral: Loaded sit-to-stand exercise
Primary Outcome(s)
Gross Motor Function Measure [Time Frame: 12 weeks]
Secondary Outcome(s)
Pediatric Evaluation of Disability Inventory [Time Frame: 12 weeks]
One-repetition maximum of loaded sit-to-stand test [Time Frame: 12 weeks]
Intrinsic Motivation Inventory-Chinese Version [Time Frame: 12 weeks]
Exercise Adherence and Volume [Time Frame: 12 weeks]
Motor Control Variables of the STS Movement [Time Frame: 12 weeks]
Secondary ID(s)
0971762466
98-2314-B-002-011-MY3
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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