NCT01367327CompletedNot Applicable
Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
National Taiwan University Hospital1 site in 1 country36 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Gross Motor Function Measure
Study Overview
Brief Summary
The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exercise with music
Experimental
Loaded sit-to-stand exercise with music for 6 weeks
Intervention: Loaded sit-to-stand exercise (Behavioral)
Exercise with music
Experimental
Loaded sit-to-stand exercise with music for 6 weeks
Intervention: Synchronized music (Behavioral)
Exercise without music
Active Comparator
Loaded sit-to-stand exercise without music for 6 weeks
Intervention: Loaded sit-to-stand exercise (Behavioral)
Outcomes
Primary Outcomes
Gross Motor Function Measure
Time Frame: 12 weeks
Secondary Outcomes
- Intrinsic Motivation Inventory-Chinese Version(12 weeks)
- Exercise Adherence and Volume(12 weeks)
- Motor Control Variables of the STS Movement(12 weeks)
- Pediatric Evaluation of Disability Inventory(12 weeks)
- One-repetition maximum of loaded sit-to-stand test(12 weeks)
Investigators
Study Sites (1)
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