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

Cerebral Palsy Clinical Trial

Official title:

Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01367340
• Other study ID #: 0993702914
• Secondary ID: 98-2314-B-002-01
• Status: Active, not recruiting
• Phase: N/A
• First received: August 9, 2010
• Last updated: May 16, 2012
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 13 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Diplegia

Intervention

Behavioral:
• Loaded sit-to-stand resistance exercise
Loaded STS exercise at home, 3 times a week for 6 weeks
• 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.

Locations

Country	Name	City	State
Taiwan	Institute of Physical Therapy, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure		1.5 months	No
Secondary	One-repetition maximum of loaded sit-to-stand		1.5 months	No
Secondary	Gait speed		Week 0, 6, 12, 18, 24, 36, 42, 48, 72	No
Secondary	1-minute walk test		1.5 months	No
Secondary	School Function Assessment		3 months	No
Secondary	Pediatric Evaluation of Disability Inventory		1.5 months	No
Secondary	Physical activity status by International Physical Activity Questionnaire and accelerometer		3 months	No