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Clinical Trials/NCT01367340
NCT01367340
Unknown
Not 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 enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
National Taiwan University Hospital
Enrollment
32
Locations
1
Primary Endpoint
Gross Motor Function Measure
Last Updated
13 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
December 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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