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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: August 9, 2010
Last updated: May 16, 2012
Last verified: February 2012
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.

Condition Intervention
Cerebral Palsy Spastic Diplegia Behavioral: Loaded sit-to-stand resistance exercise Behavioral: Physical activity intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Gross Motor Function Measure [ Time Frame: 1.5 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise and physical activity Behavioral: Loaded sit-to-stand resistance exercise
Loaded STS exercise at home, 3 times a week for 6 weeks
Behavioral: 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: Exercise only Behavioral: Loaded sit-to-stand resistance exercise
Loaded STS exercise at home, 3 times a week for 6 weeks


Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   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
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Please refer to this study by its identifier: NCT01367340

Institute of Physical Therapy, National Taiwan University
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Hua-Fang Liao, MS Institute of Physical Therapy, National Taiwan University
  More Information

Responsible Party: National Taiwan University Hospital Identifier: NCT01367340     History of Changes
Other Study ID Numbers: 0993702914
98-2314-B-002-011-MY3 ( Other Grant/Funding Number: NSC of ROC )
Study First Received: August 9, 2010
Last Updated: May 16, 2012

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms processed this record on July 21, 2017