Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

Conditions
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Cerebral Palsy, Paraparesis, Spastic

Intervention / Treatment
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* Behavioral: Loaded sit-to-stand exercise
* Behavioral: Synchronized music


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise with music<br>Loaded sit-to-stand exercise with music for 6 weeks | Behavioral: Loaded sit-to-stand exercise<br>* Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks<br>Behavioral: Synchronized music<br>* Synchronized music for loaded sit-to-stand exercise to guide movement<br>|
| Active Comparator: Exercise without music<br>Loaded sit-to-stand exercise without music for 6 weeks | Behavioral: Loaded sit-to-stand exercise<br>* Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise