Overview

This trial is active, not recruiting.

Conditions cerebral palsy, spastic diplegia
Treatments loaded sit-to-stand resistance exercise, physical activity intervention
Sponsor National Taiwan University Hospital
Start date August 2010
End date December 2012
Trial size 32 participants
Trial identifier NCT01367340, 0993702914, 98-2314-B-002-011-MY3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
loaded sit-to-stand resistance exercise
Loaded STS exercise at home, 3 times a week for 6 weeks
physical activity intervention
The intervention is based on the social cognitive theory and the transtheoretical model. There are two principle components, the individual consultation and the small group PA activities. In the individual consultation, assessment of current stage of readiness for PA will be performed first. Then, individualized, stage-matched feedback will be sent to the participants. Small group PA activities will be held every 2 weeks in order to increase learning opportunity by peer interaction, make exercise fun, and introduce a role model.
(Active Comparator)
loaded sit-to-stand resistance exercise
Loaded STS exercise at home, 3 times a week for 6 weeks

Primary Outcomes

Measure
Gross Motor Function Measure
time frame: 1.5 months

Secondary Outcomes

Measure
One-repetition maximum of loaded sit-to-stand
time frame: 1.5 months
Gait speed
time frame: Week 0, 6, 12, 18, 24, 36, 42, 48, 72
1-minute walk test
time frame: 1.5 months
School Function Assessment
time frame: 3 months
Pediatric Evaluation of Disability Inventory
time frame: 1.5 months
Physical activity status by International Physical Activity Questionnaire and accelerometer
time frame: 3 months

Eligibility Criteria

Male or female participants from 5 years up to 13 years old.

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

Additional Information

Official title Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.