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

Study Overview
=================
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.

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

Conditions
-----------------
Cerebral Palsy, Spastic Diplegia

Intervention / Treatment
-----------------
* Behavioral: Loaded sit-to-stand resistance exercise
* Behavioral: Physical activity intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and physical activity<br> | Behavioral: Loaded sit-to-stand resistance exercise<br>* Loaded STS exercise at home, 3 times a week for 6 weeks<br>Behavioral: Physical activity intervention<br>* 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.<br>|
| Active Comparator: Exercise only<br> | Behavioral: Loaded sit-to-stand resistance exercise<br>* Loaded STS exercise at home, 3 times a week for 6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure |  | 1.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |