Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

NCT ID: NCT01049581

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-11-30

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.

Conditions

Spastic Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

aquatic therapy

Intervention Type: PROCEDURE

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

conventional therapy

The children included in the control group continued with their original rehabilitation programs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

aquatic therapy

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

Intervention Type: PROCEDURE

Other Intervention Names

physical therapy

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ChiaLing Chen

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

981947B

Identifier Type: -

Identifier Source: org_study_id