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Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

Primary Purpose

Cerebral Palsy, Paraparesis, Spastic

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Loaded sit-to-stand exercise
Synchronized music
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 focused on measuring Exercise

Eligibility Criteria

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

Inclusion Criteria:

  • children with SD, aged 5 to 13 year-old, and 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 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
  • have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders

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 with music

Exercise without music

Arm Description

Loaded sit-to-stand exercise with music for 6 weeks

Loaded sit-to-stand exercise without music for 6 weeks

Outcomes

Primary Outcome Measures

Gross Motor Function Measure

Secondary Outcome Measures

Intrinsic Motivation Inventory-Chinese Version
Exercise Adherence and Volume
Motor Control Variables of the STS Movement
Pediatric Evaluation of Disability Inventory
One-repetition maximum of loaded sit-to-stand test

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
NCT01367327
Brief Title
Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Official Title
Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

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 study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exercise with music
Arm Type
Experimental
Arm Description
Loaded sit-to-stand exercise with music for 6 weeks
Arm Title
Exercise without music
Arm Type
Active Comparator
Arm Description
Loaded sit-to-stand exercise without music for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Loaded sit-to-stand exercise
Intervention Description
Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Synchronized music
Intervention Description
Synchronized music for loaded sit-to-stand exercise to guide movement
Primary Outcome Measure Information:
Title
Gross Motor Function Measure
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intrinsic Motivation Inventory-Chinese Version
Time Frame
12 weeks
Title
Exercise Adherence and Volume
Time Frame
12 weeks
Title
Motor Control Variables of the STS Movement
Time Frame
12 weeks
Title
Pediatric Evaluation of Disability Inventory
Time Frame
12 weeks
Title
One-repetition maximum of loaded sit-to-stand test
Time Frame
12 weeks

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 SD, aged 5 to 13 year-old, and 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 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 have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders
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
background
PubMed Identifier
21185725
Citation
Peng YC, Lu TW, Wang TH, Chen YL, Liao HF, Lin KH, Tang PF. Immediate effects of therapeutic music on loaded sit-to-stand movement in children with spastic diplegia. Gait Posture. 2011 Feb;33(2):274-8. doi: 10.1016/j.gaitpost.2010.11.020. Epub 2010 Dec 24.
Results Reference
background

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Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

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