NCT01367340UnknownNot Applicable
Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
National Taiwan University Hospital1 site in 1 country32 target enrollmentStarted: August 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Gross Motor Function Measure
Study Overview
Brief Summary
The purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. The primary outcomes are gross motor function, participation, and physical activity behavior.
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 spastic diplegia, aged 6 to 12 year-old, and Gross Motor Function Classification System (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 answer questionnaire designed for school-age children
- •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
Arms & Interventions
Exercise and physical activity
Experimental
Intervention: Loaded sit-to-stand resistance exercise (Behavioral)
Exercise and physical activity
Experimental
Intervention: Physical activity intervention (Behavioral)
Exercise only
Active Comparator
Intervention: Loaded sit-to-stand resistance exercise (Behavioral)
Outcomes
Primary Outcomes
Gross Motor Function Measure
Time Frame: 1.5 months
Secondary Outcomes
- One-repetition maximum of loaded sit-to-stand(1.5 months)
- Gait speed(Week 0, 6, 12, 18, 24, 36, 42, 48, 72)
- 1-minute walk test(1.5 months)
- School Function Assessment(3 months)
- Pediatric Evaluation of Disability Inventory(1.5 months)
- Physical activity status by International Physical Activity Questionnaire and accelerometer(3 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer SurvivorsPhysical ActivityBreast CancerNCT02763228Case Comprehensive Cancer Center218
Unknown
Not Applicable
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and MetabolismOverweightSedentaryNCT02020239University of Birmingham60
Unknown
Not Applicable
Examining the Association Between Physical Activity and Sleep Quality in Children With Autism Spectrum DisorderPhysical ActivitySleep ApneaAutism Spectrum DisorderNCT03348982The Hong Kong Polytechnic University32
Recruiting
Not Applicable
The effect of physical activity intervention on mood, marital satisfaction, sexual self-concept, serotonin and adrenaline levelsPsychological changes of birth control pills consumption.Encounter for surveillance of contraceptive pillsZ30.41IRCT20180918041066N1Abadan University of Medical Sciences70
Completed
Not Applicable
Investigation of the Effects of Physical Activity in Women at Risk of OsteoporosisOsteoporosis RiskNCT06081764Pamukkale University40