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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
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

August 9, 2010
May 16, 2012
August 2010
December 2012   (final data collection date for primary outcome measure)
Gross Motor Function Measure [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01367340 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Motion Analysis of STS Movement [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training
Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Cerebral Palsy
  • Spastic Diplegia
  • 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.
  • Experimental: Exercise and physical activity
    Interventions:
    • Behavioral: Loaded sit-to-stand resistance exercise
    • Behavioral: Physical activity intervention
  • Active Comparator: Exercise only
    Intervention: Behavioral: Loaded sit-to-stand resistance exercise
Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
5 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01367340
0993702914, 98-2314-B-002-011-MY3
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Chair: Hua-Fang Liao, MS Institute of Physical Therapy, National Taiwan University
National Taiwan University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP