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

May 16, 2012 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise with music
Loaded sit-to-stand exercise with music for 6 weeks
Behavioral: Loaded sit-to-stand exercise
Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks
Behavioral: Synchronized music
Synchronized music for loaded sit-to-stand exercise to guide movement
Active Comparator: Exercise without music
Loaded sit-to-stand exercise without music for 6 weeks
Behavioral: Loaded sit-to-stand exercise
Loaded sit-to-stand 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
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Intrinsic Motivation Inventory-Chinese Version
Time Frame: 12 weeks
12 weeks
Exercise Adherence and Volume
Time Frame: 12 weeks
12 weeks
Motor Control Variables of the STS Movement
Time Frame: 12 weeks
12 weeks
Pediatric Evaluation of Disability Inventory
Time Frame: 12 weeks
12 weeks
One-repetition maximum of loaded sit-to-stand test
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0971762466
  • 98-2314-B-002-011-MY3 (Other Grant/Funding Number: NSC of ROC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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