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CompletedNCT01049581Updated Feb 11, 2015Results posted

Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

An interventional study of aquatic therapy in Spastic Cerebral Palsy, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-02-11.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
4 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Spastic Cerebral Palsy

Keywords

  • Gross motor function performance
  • pediatric aquatic therapy
  • spastic cerebral palsy
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 27 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
27 participants (actual)

Study arms

  • 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

  • No intervention
    conventional therapy

    The children included in the control group continued with their original rehabilitation programs

Interventions

  • Procedureaquatic therapy

    two hours per week, one hour per time, total 12 weeks

    Also known as: physical therapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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

    Time frame: 3months

07

Results

Posted Feb 11, 2015
Limitations and caveats
no pain or falling down or other adverse effect were report

Participant flow

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.

Participant flow — Overall Study
MilestonePediatric Aquatic Therapy GroupConventional Therapy Group
Started1314
Completed1113
Not completed21
Withdrew: Lost to follow-up21

Outcome measures

PrimaryUnit 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

Time frame:
3 months
Reported as:
Mean · units on a scale
Unit on Gross Motor Function Measure Scale (GMFM)
units on a scalePediatric Aquatic TherapyConventional Therapy
Unit on Gross Motor Function Measure Scale (GMFM)5.12 ± 4.52.00 ± 2.7
Statistical analysis
  • Pediatric Aquatic Therapy vs Conventional Therapy · ANCOVA · p = 0.007
SecondaryDaily 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.

Time frame:
3 months
Reported as:
Mean · units on a scale
Daily Living Subscale of Vineland Adaptive Behavior Scale
units on a scalePediatric Aquatic TherapyConventional Therapy
Daily Living Subscale of Vineland Adaptive Behavior Scale81.8 ± 48.992.1 ± 38.5
Statistical analysis
  • Pediatric Aquatic Therapy · ANCOVA · p = 0.393 (Effect Size η2 0.023) · Mean difference (net): 1.762F1,17= 0.380
SecondarySubscale 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

Time frame:
3months
Reported as:
Mean · units on a scale
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
units on a scalePediatric Aquatic TherapyConventional Therapy
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children69.6 ± 8.368.5 ± 14.6
Statistical analysis
  • Pediatric Aquatic Therapy vs Conventional Therapy · ANCOVA · p = 0.332

Adverse events

Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Effects of Pediatric Aquatic Therapy on Motor Performance—0/27 (0%)—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pediatric Aquatic Therapy GroupConventional Therapy GroupTotal
<=18 years131427
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Pediatric Aquatic Therapy GroupConventional Therapy GroupTotal
Mean7 ± 36 ± 2.57 ± 0.25
Sex: Female, Male
Sex: Female, Male(Participants)Pediatric Aquatic Therapy GroupConventional Therapy GroupTotal
Female8412
Male51015
Region of Enrollment
Region of Enrollment(participants)Pediatric Aquatic Therapy GroupConventional Therapy GroupTotal
Taiwan131427
08

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taipei, Taiwan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01049581
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jan 14, 2010
Start date
Oct 2009
Primary completion
Jul 2010
Completion
Nov 2010
Results posted
Feb 11, 2015
Last update
Feb 11, 2015

Study contacts

ChiaLing Chen
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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