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Completed

NCT Number: NCT01367327

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

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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Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Motor Activity Nervous System Diseases Neurologic Manifestations Paraparesis Paraparesis, Spastic Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Gross Motor Function Measure

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2011
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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