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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:
National Taiwan University Hospital
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
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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 (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:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Gross Motor Function Measure [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- Intrinsic Motivation Inventory-Chinese Version [ Time Frame: 12 weeks ]
- Exercise Adherence and Volume [ Time Frame: 12 weeks ]
- Motor Control Variables of the STS Movement [ Time Frame: 12 weeks ]
- Pediatric Evaluation of Disability Inventory [ Time Frame: 12 weeks ]
- One-repetition maximum of loaded sit-to-stand test [ Time Frame: 12 weeks ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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 ( Other Grant/Funding Number: NSC of ROC ) |
| Study First Received: | August 9, 2010 |
| Last Updated: | May 16, 2012 |
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 21, 2017