Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

NCT01049581 | Completed Results DMC

• 1 other identifier: 981947B
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy

Keywords

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

Outcome Measures

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

  3 months

Secondary Outcomes (2)

• Daily Living Subscale of Vineland Adaptive Behavior Scale

  3 months

• Subscale on Cerebral Palsy Quality of Life Questionnaire for Children

  3months

Study Arms (2)

pediatric aquatic therapy

EXPERIMENTAL

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

conventional therapy

NO INTERVENTION

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

Interventions

aquatic therapy PROCEDURE

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

Also known as: physical therapy

pediatric aquatic therapy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Aquatic Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Therapeutics; Rehabilitation

Limitations and Caveats

no pain or falling down or other adverse effect were report

Results Point of Contact

• Title: Dr Chia- Ling Chen
• Organization: ChangGungMH

clingchen@gmail.com

886-3-3281200

Study Officials

• ChiaLing Chen

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 14, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2010-02

Locations

TW (1)