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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367340
First Posted: June 7, 2011
Last Update Posted: May 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367340


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

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01367340     History of Changes
Other Study ID Numbers: 0993702914
98-2314-B-002-011-MY3 ( Other Grant/Funding Number: NSC of ROC )
First Submitted: August 9, 2010
First Posted: June 7, 2011
Last Update Posted: May 17, 2012
Last Verified: February 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