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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01367327
First received: August 9, 2010
Last updated: May 16, 2012
Last verified: February 2012
History of Changes
  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:

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
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
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:

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

ClinicalTrials.gov processed this record on May 23, 2013