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Completed

NCT Number: NCT01049581

Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taipei, Taiwan

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of psychiatric diseases
  • Poor controlled epilepsy
  • Received botox injection or surgery in recent three months
  • Children diagnosed as attention deficit hyperactivity disorder(ADHD) or autism
  • Severe mental retardation
  • Active infection (Body temperature > 100°F)
  • Communication problems
  • Bowel incontinence
  • Bladder incontinence
  • Severe cardiovascular disease
  • Infectious skin conditions and open wound
  • Nasogastric tubes or gastrostomy tubes
  • Colostomy ,urostomy or ileostomy bags
  • Acute orthopedic injury with pain and instability
  • Diabetes
  • Chlorine sensitivity
  • Latex allergies
  • Tracheostomy

Treatment and study plan

Aquatic therapy

Procedure

two hours per week, one hour per time, total 12 weeks

Other names: physical therapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2010
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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