Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training

Not Applicable

• Conditions: Cerebral Palsy; Spastic Diplegia
• Interventions: Behavioral: Loaded sit-to-stand resistance exercise; Behavioral: Physical activity intervention

• Registration Number: NCT01367340
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise and physical activity	Loaded sit-to-stand resistance exercise	-
Exercise and physical activity	Physical activity intervention	-
Exercise only	Loaded sit-to-stand resistance exercise	-

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure	1.5 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Physical Therapy, National Taiwan University; 🇨🇳 Taipei, Taiwan