- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- Chang Gung Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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
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two hours per week, one hour per time, total 12 weeks
Other Names:
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No Intervention: conventional therapy
The children included in the control group continued with their original rehabilitation programs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Daily Living Subscale of Vineland Adaptive Behavior Scale
Time Frame: 3 months
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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.
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3 months
|
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Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
Time Frame: 3months
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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
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3months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: ChiaLing Chen, Chang Gung Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 981947B
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