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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy; Paraparesis, Spastic	Behavioral: Loaded sit-to-stand exercise; Behavioral: Synchronized music	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
Study Start Date :	January 2009
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Gross Motor Function Measure [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Intrinsic Motivation Inventory-Chinese Version [ Time Frame: 12 weeks ]
2. Exercise Adherence and Volume [ Time Frame: 12 weeks ]
3. Motor Control Variables of the STS Movement [ Time Frame: 12 weeks ]
4. Pediatric Evaluation of Disability Inventory [ Time Frame: 12 weeks ]
5. One-repetition maximum of loaded sit-to-stand test [ Time Frame: 12 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	5 Years to 13 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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.

Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01367327 History of Changes
Other Study ID Numbers:	0971762466; 98-2314-B-002-011-MY3 ( Other Grant/Funding Number: NSC of ROC )
First Posted:	June 7, 2011
Last Update Posted:	May 17, 2012
Last Verified:	February 2012

Keywords provided by National Taiwan University Hospital:

Exercise

Additional relevant MeSH terms:

Cerebral Palsy; Muscle Spasticity; Paraparesis; Paraparesis, Spastic; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Paresis