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

NCT ID: NCT01367340

Last Updated: 2012-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Cerebral Palsy; Spastic Diplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise and physical activity

Group Type: EXPERIMENTAL

Loaded sit-to-stand resistance exercise

Intervention Type: BEHAVIORAL

Loaded STS exercise at home, 3 times a week for 6 weeks

Physical activity intervention

Intervention Type: BEHAVIORAL

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.

Exercise only

Group Type: ACTIVE_COMPARATOR

Loaded sit-to-stand resistance exercise

Intervention Type: BEHAVIORAL

Loaded STS exercise at home, 3 times a week for 6 weeks

Interventions

Loaded sit-to-stand resistance exercise

Loaded STS exercise at home, 3 times a week for 6 weeks

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hua-Fang Liao, MS

Role: STUDY_CHAIR

Institute of Physical Therapy, National Taiwan University

Locations

Institute of Physical Therapy, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

References

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. doi: 10.1016/j.apmr.2006.10.006.

Reference Type: BACKGROUND

PMID: 17207671 (View on PubMed)

Other Identifiers

98-2314-B-002-011-MY3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0993702914

Identifier Type: -

Identifier Source: org_study_id