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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Spastic Diplegia
• Intervention / Treatment: Behavioral: Loaded sit-to-stand resistance exercise; Behavioral: Physical activity intervention

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Institute of Physical Therapy, National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gross Motor Function Measure	1.5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
One-repetition maximum of loaded sit-to-stand	1.5 months
Gait speed	Week 0, 6, 12, 18, 24, 36, 42, 48, 72
1-minute walk test	1.5 months
School Function Assessment	3 months
Pediatric Evaluation of Disability Inventory	1.5 months
Physical activity status by International Physical Activity Questionnaire and accelerometer	3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Hua-Fang Liao, MS, Institute of Physical Therapy, National Taiwan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 9, 2010
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): May 17, 2012
• Last Update Submitted That Met QC Criteria: May 16, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: 0993702914; 98-2314-B-002-011-MY3 (Other Grant/Funding Number: NSC of ROC)