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

Purpose

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	Intervention
Cerebral Palsy Paraparesis, Spastic	Behavioral: Loaded sit-to-stand exercise Behavioral: Synchronized music


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

Genetic and Rare Diseases Information Center resources: Cerebral Palsy

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Gross Motor Function Measure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intrinsic Motivation Inventory-Chinese Version [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Exercise Adherence and Volume [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Motor Control Variables of the STS Movement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Pediatric Evaluation of Disability Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
One-repetition maximum of loaded sit-to-stand test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Enrollment:	36
Study Start Date:	January 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	5 Years to 13 Years (Child)
Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01367327

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

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
Study First Received:	August 9, 2010
Last Updated:	May 16, 2012
Health Authority:	Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on September 28, 2016