Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01049581
First received: January 4, 2010
Last updated: February 10, 2015
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 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 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:
  • Unit on Gross Motor Function Measure Scale (GMFM) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Daily Living Subscale of Vineland Adaptive Behavior Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 27
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: ChiaLing Chen Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01049581     History of Changes
Other Study ID Numbers: 981947B
Study First Received: January 4, 2010
Results First Received: June 3, 2013
Last Updated: February 10, 2015
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Gross motor function performance
pediatric aquatic therapy
spastic cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 27, 2015