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Trial record 1 of 1 for:    NCT01049581
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Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049581
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Aquatic intervention had been applied in children with neuromotor impairment for years, yet there has been little progress toward objective identifications of therapy goals, interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for children with cerebral palsy to evaluate the effect of hydrotherapy.


To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and social participation in children with spastic cerebral palsy.


The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These children were dived into two groups: traditional rehabilitation therapy (control group), and hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily activity and social participation before and after the intervention and compared the difference in improvement between groups. The measurements include modified Ashworth score, Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL).

Expect effect:

We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor function and daily activity.Children could improve self-esteem and we hypothesize this could improve social participation.

Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Procedure: aquatic therapy Not Applicable

Detailed Description:
  • We conducted a well-designed study to investigate the effectiveness of PAT on motor function, activities of daily living (ADL),and health related quality of life(HRQOL) perspectives for children with CP.
  • A convenience sample of 27 children was recruited for the study from the outpatient clinics of the Department of Physical Medicine and Rehabilitation of two tertiary hospitals: Chang Gung Memorial Hospital and Taipei Veterans General Hospital.
  • The study was designed as a single blinded, prospective, case control study.
  • The pediatric aquatic therapy group got more improvementon motor performance measured by GMFM-66.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: pediatric aquatic therapy
The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs
Procedure: aquatic therapy
two hours per week, one hour per time, total 12 weeks
Other Name: physical therapy

No Intervention: conventional therapy
The children included in the control group continued with their original rehabilitation programs

Primary Outcome Measures :
  1. Unit on Gross Motor Function Measure Scale (GMFM) [ Time Frame: 3 months ]
    The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy

Secondary Outcome Measures :
  1. Daily Living Subscale of Vineland Adaptive Behavior Scale [ Time Frame: 3 months ]
    Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.

  2. Subscale on Cerebral Palsy Quality of Life Questionnaire for Children [ Time Frame: 3months ]
    This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Children diagnosed as cerebral palsy, spastic type
  2. Gross Motor Functional Classification (GMFCS) level II-IV
  3. Age: 4-12 y/o
  4. Informed consent by parents
  5. Modified Ashworth score 2 or3
  6. If participant history of epilepsy ,well controlled by medication

Exclusion Criteria:

  1. History of psychiatric diseases
  2. Poor controlled epilepsy
  3. Received botox injection or surgery in recent three months
  4. Children diagnosed as attention deficit hyperactivity disorder(ADHD) or autism
  5. Severe mental retardation
  6. Active infection (Body temperature > 100°F)
  7. Communication problems
  8. Bowel incontinence
  9. Bladder incontinence
  10. Severe cardiovascular disease
  11. Infectious skin conditions and open wound
  12. Nasogastric tubes or gastrostomy tubes
  13. Colostomy ,urostomy or ileostomy bags
  14. Acute orthopedic injury with pain and instability
  15. Diabetes
  16. Chlorine sensitivity
  17. Latex allergies
  18. Tracheostomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049581

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Chang Gung Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Study Director: ChiaLing Chen Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital Identifier: NCT01049581    
Other Study ID Numbers: 981947B
First Posted: January 14, 2010    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015
Last Verified: February 2010
Keywords provided by Chang Gung Memorial Hospital:
Gross motor function performance
pediatric aquatic therapy
spastic cerebral palsy
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations