Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

Spastic Cerebral Palsy Clinical Trial

Official title:

Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049581
• Other study ID #: 981947B
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: February 10, 2015
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2010
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Cerebral Palsy

Intervention

Procedure:
• aquatic therapy
two hours per week, one hour per time, total 12 weeks

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unit on Gross Motor Function Measure Scale (GMFM)	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	3 months	No
Secondary	Daily Living Subscale of Vineland Adaptive Behavior Scale	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.	3 months	No
Secondary	Subscale on Cerebral Palsy Quality of Life Questionnaire for Children	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	3months	Yes