Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

• ClinicalTrials.gov Identifier: NCT01049581
• Recruitment Status: Completed
• First Posted: January 14, 2010
• Results First Posted: February 11, 2015
• Last Update Posted: February 11, 2015
• Sponsor: Chang Gung Memorial Hospital
• Information provided by (Responsible Party): Chang Gung Memorial Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spastic Cerebral Palsy	Procedure: aquatic therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
• Study Start Date: October 2009
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT01049581
• Other Study ID Numbers: 981947B
• First Posted: January 14, 2010
• Results First Posted: February 11, 2015
• Last Update Posted: February 11, 2015
• Last Verified: February 2010

Keywords provided by Chang Gung Memorial Hospital:

Gross motor function performance; pediatric aquatic therapy; spastic cerebral palsy

Additional relevant MeSH terms:

Muscle Spasticity; Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations