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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01367340
First received: August 9, 2010
Last updated: May 16, 2012
Last verified: February 2012
History of Changes
  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 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:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Gross Motor Function Measure [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One-repetition maximum of loaded sit-to-stand [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
  • Gait speed [ Time Frame: Week 0, 6, 12, 18, 24, 36, 42, 48, 72 ] [ Designated as safety issue: No ]
  • 1-minute walk test [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
  • School Function Assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pediatric Evaluation of Disability Inventory [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
  • Physical activity status by International Physical Activity Questionnaire and accelerometer [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 9, 2010
Last Updated: May 16, 2012
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on June 18, 2013