Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Primary Purpose
Spastic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
aquatic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Gross motor function performance, pediatric aquatic therapy, spastic cerebral palsy
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pediatric aquatic therapy
conventional therapy
Arm Description
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
The children included in the control group continued with their original rehabilitation programs
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT01049581
First Posted
January 4, 2010
Last Updated
February 10, 2015
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01049581
Brief Title
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
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Gross motor function performance, pediatric aquatic therapy, spastic cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pediatric aquatic therapy
Arm Type
Experimental
Arm Description
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
Arm Title
conventional therapy
Arm Type
No Intervention
Arm Description
The children included in the control group continued with their original rehabilitation programs
Intervention Type
Procedure
Intervention Name(s)
aquatic therapy
Other Intervention Name(s)
physical therapy
Intervention Description
two hours per week, one hour per time, total 12 weeks
Primary Outcome Measure Information:
Title
Unit on Gross Motor Function Measure Scale (GMFM)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Daily Living Subscale of Vineland Adaptive Behavior Scale
Description
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.
Time Frame
3 months
Title
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
Description
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
Time Frame
3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ChiaLing Chen
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
We'll reach out to this number within 24 hrs