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Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01049581
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE January 4, 2010
First Posted Date  ICMJE January 14, 2010
Results First Submitted Date  ICMJE June 3, 2013
Results First Posted Date  ICMJE February 11, 2015
Last Update Posted Date February 11, 2015
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
Gross Motor Function Measure (GMFM) [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
Vineland Adaptive Behavior Scale, Cerebral Palsy Quality of Life Questionnaire for Children [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Official Title  ICMJE Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
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.

Purpose:

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

Method:

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Spastic Cerebral Palsy
Intervention  ICMJE Procedure: aquatic therapy
two hours per week, one hour per time, total 12 weeks
Other Name: physical therapy
Study Arms  ICMJE
  • 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
    Intervention: Procedure: aquatic therapy
  • No Intervention: conventional therapy
    The children included in the control group continued with their original rehabilitation programs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2015)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2010)
45
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049581
Other Study ID Numbers  ICMJE 981947B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ChiaLing Chen Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP