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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367327
• Other study ID #: 0971762466
• Secondary ID: 98-2314-B-002-01
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: May 16, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paraparesis
• Paraparesis, Spastic

Intervention

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

Locations

Country	Name	City	State
Taiwan	Institute of Physical Therapy, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure		12 weeks	No
Secondary	Intrinsic Motivation Inventory-Chinese Version		12 weeks	No
Secondary	Exercise Adherence and Volume		12 weeks	No
Secondary	Motor Control Variables of the STS Movement		12 weeks	No
Secondary	Pediatric Evaluation of Disability Inventory		12 weeks	No
Secondary	One-repetition maximum of loaded sit-to-stand test		12 weeks	No