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Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01049581
First received: January 4, 2010
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

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 was design as case -control study. 45 children with spastic cerebral palsy aged from 4 to 12 years old were included. They were paired by age, diagnosis, Gross Motor Functional Classification (GMFCS) level and Manual Ability Classification System (MACS). These children were dived into three groups: traditional rehabilitation therapy (control group), hospital based pediatric aquatic therapy, and community based- athletic trainer oriented pediatric aquatic therapy program. After 12 weeks training program, we evaluate the motor performance, daily activity and social participation again and compared the difference in improvement between each group. The clinical measurements include manual muscle power, modified Ashworth score, Bruininks- Oseretsky Test of Motor Proficiency (BOTMP), Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL). BASIC BALANCE MASTER was used in this study for evaluated the balance function.

Expect effect:

We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor function and daily activity. Freedom in the water has both therapeutic and recreational effects. Children could improve self-esteem and we hypothesize this could improve emotional control and social participation.


Condition Intervention
Spastic Cerebral Palsy
Procedure: aquatic therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Gross Motor Function Measure (GMFM) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vineland Adaptive Behavior Scale, Cerebral Palsy Quality of Life Questionnaire for Children [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aquatic Procedure: aquatic therapy
two hours per week, one hour per time
Procedure: aquatic therapy
hospital based pediatric aquatic therapy, twice per week, one hour each time

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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. Nasogastic 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049581

Contacts
Contact: Chia-Ling Chen +886-3-3281200 ext 3846 clingchen@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Chia-Ling Chen, PHD    +886-3-3281200 ext 3846    clingchen@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Effects of pediatric aquatic therapy in children with spastic cerebral palsy, Department of Physical Medicine & Rehabilitation
ClinicalTrials.gov Identifier: NCT01049581     History of Changes
Other Study ID Numbers: 981947B
Study First Received: January 4, 2010
Last Updated: February 22, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Gross motor function performance
physical performance

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 24, 2014