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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

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

First Posted
January 4, 2010
Last Updated
February 10, 2015
Sponsor
Chang Gung Memorial Hospital
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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

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Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

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