Clinical trial NCT01049581: Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Official title: Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: Gross motor function performance
pediatric aquatic therapy
spastic cerebral palsy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 27
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Unit on Gross Motor Function Measure Scale (GMFM)
timeFrame: 3 months
Secondary outcomes:
measure: Daily Living Subscale of Vineland Adaptive Behavior Scale
timeFrame: 3 months
measure: Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
timeFrame: 3months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: ChiaLing Chen
role: STUDY_DIRECTOR
References: