Spastic Cerebral PalsyNCT01049581
Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
A study testing aquatic therapy in people with Spastic Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- aquatic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- aquatic therapy
- Keywords
- Gross motor function performance, pediatric aquatic therapy, spastic cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic therapyProcedure or surgery
Also called physical therapy
two hours per week, one hour per time, total 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: aquatic therapy |
| conventional therapy | No intervention | The children included in the control group continued with their original rehabilitation programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ChiaLing Chen, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049581
- Sponsor's protocol ID
- 981947B
- Status last verified
- Feb 2010
- First submitted
- 4 Jan 2010
- Last updated
- 11 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01049581
- Acronym / sponsor ID
- 981947B
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Gross motor function performance, pediatric aquatic therapy, spastic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pediatric aquatic therapy | Experimental | Procedure: aquatic therapyThe children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs |
| conventional therapy | No intervention | –The children included in the control group continued with their original rehabilitation programs |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aquatic therapyAlso: physical therapytwo hours per week, one hour per time, total 12 weeks | Procedure or surgery | pediatric aquatic therapy |
Primary outcome
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
2 secondary outcomes
Daily Living Subscale of Vineland Adaptive Behavior Scale
Time frame: 3 months
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
Time frame: 3months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChiaLing Chen study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic therapy in people with Spastic Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unit on Gross Motor Function Measure Scale (GMFM) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.