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

NCT01367327 — Not applicable, Completed, 36 participants, National Taiwan University Hospital

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Registry	NCT01367327
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	36 (Actual)
Sponsor	National Taiwan University Hospital (Other)
Conditions	Cerebral Palsy, Paraparesis, Spastic
Interventions	Loaded sit-to-stand exercise, Synchronized music (Behavioral)
Dates	start 2009-01-01, primary completion 2011-12-01, completion 2011-12-01, first posted 2011-06-07, last updated 2012-05-17
Locations	1 site in Taiwan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Exercise with music	Experimental	Behavioral: Loaded sit-to-stand exercise; Behavioral: Synchronized music	Loaded sit-to-stand exercise with music for 6 weeks
Exercise without music	Active comparator	Behavioral: Loaded sit-to-stand exercise	Loaded sit-to-stand exercise without music for 6 weeks

Loaded sit-to-stand exercise (Behavioral): Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks
Synchronized music (Behavioral): Synchronized music for loaded sit-to-stand exercise to guide movement

+Outcome measures

Primary outcomes

Gross Motor Function Measure [12 weeks]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 5 Years to 13 Years

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

+Locations (1)

Facility	City	Country	Status
Institute of Physical Therapy, National Taiwan University	Taipei	Taiwan

+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. doi: 10.1016/j.apmr.2006.10.006. PMID 17207671
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. PMID 21185725

+Investigators

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