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

Primary Purpose

Cerebral Palsy, Spastic Diplegia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Loaded sit-to-stand resistance exercise
Physical activity intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Physical Therapy, National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and physical activity

Exercise only

Arm Description

Outcomes

Primary Outcome Measures

Gross Motor Function Measure

Secondary Outcome Measures

One-repetition maximum of loaded sit-to-stand
Gait speed
1-minute walk test
School Function Assessment
Pediatric Evaluation of Disability Inventory
Physical activity status by International Physical Activity Questionnaire and accelerometer

Full Information

First Posted
August 9, 2010
Last Updated
May 16, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01367340
Brief Title
Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training
Official Title
Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Diplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and physical activity
Arm Type
Experimental
Arm Title
Exercise only
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Loaded sit-to-stand resistance exercise
Intervention Description
Loaded STS exercise at home, 3 times a week for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure
Time Frame
1.5 months
Secondary Outcome Measure Information:
Title
One-repetition maximum of loaded sit-to-stand
Time Frame
1.5 months
Title
Gait speed
Time Frame
Week 0, 6, 12, 18, 24, 36, 42, 48, 72
Title
1-minute walk test
Time Frame
1.5 months
Title
School Function Assessment
Time Frame
3 months
Title
Pediatric Evaluation of Disability Inventory
Time Frame
1.5 months
Title
Physical activity status by International Physical Activity Questionnaire and accelerometer
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua-Fang Liao, MS
Organizational Affiliation
Institute of Physical Therapy, National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Physical Therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17207671
Citation
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.
Results Reference
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Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training

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