Cerebral PalsyNCT04770298
Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy
A study testing Halliwick Concept in people with Cerebral Palsy, run by University of Thessaly at 1 site in Greece.
Trial summary
Investigation of the effectiveness of water based therapy on children with Cerebral Palsy (CP) Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Halliwick Concept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2022to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with Cerebral Palsy
- Not have some type of surgery or botulinum toxin infusion in the last year.
- The children with cognitive limitations were selected, in order to be able to execute elementary commands.
- Attending treatment program by the same therapist, either on water, or on land.
Who cannot join
- Children with autism
- Children who had some scheduled surgery or botulinum toxin injection.
- Children with severe vision problems
- Children who could not follow the verbal instructions or reproduce a test reproduction.
- Children who were absent from the treatment program either in the water or on land for over a week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Bobath Neurodevelopmental Treatment and Halliwick Concept Hydrotherapy in the Treatment of Children With Cerebral Palsy.
Investigation of the effectiveness of water based therapy on children with Cerebral Palsy (CP)
Read the detailed description
The purpose of this randomized controlled trial was:
To examine the effectiveness of the Halliwick concept intervention in water approach for people with motor deficiency and, more specifically, for children with diagnosed cerebral palsy.
In a second phase, to compare the contribution of water intervention to the child's motor development against just Bobath physiotherapeutic intervention, in terms of the milestones of gross motor skills of the children over time.
The aim of the research is to determine the contribution of the Halliwick Concept- Hydrotherapeutic Intervention approach in the psychomotor development in children with cerebral palsy and to explore its contribution to a comprehensive therapeutic approach for these children. It is a fact that, in recent years, parallel therapeutic approaches have gained ground, which, in combination with the physiotherapeutic treatment, contributes to the enhancement of therapeutic effects in early and follow-up intervention for children with cerebral palsy.
The study resulted from the fact that there is not such a large-scale study in Greece. Also, there are few published studies in the world, trying to evaluate the therapeutic benefit of the Halliwick Concept as an hydro-therapeutic approach.
- Conditions
- Cerebral Palsy
- Being tested
- Halliwick Concept
- Keywords
- aquatic therapy, pediatrics, cerebral palsy, Bobath, Halliwick
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halliwick ConceptOther
Also called Bobath Concept
Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment
| Study group | Role | What they receive |
|---|---|---|
| Halliwick Assessment Group | Experimental | 8 children with GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM (GMFCS) I, 13 children with GMFCS II, 7 GMFCS III children, 8 GMFCS IV children and 4 children with GMFCS V. Intervention in water environment (Halliwick Concept), 1 times/week- 1 intervention on land/week, 9 months duration. Receives: Other: Halliwick Concept |
| Bobath Assessment Group | Experimental | 7 children with GMFCS I, 12 children with GMFCS II, 8 children with GMFCS III, 6 children with GMFCS IV and 2 children with GMFCS V. Intervention on land ( Bobath), 2 times/week, 9 months duration. Receives: Other: Halliwick Concept |
| No intervention group | No intervention | 1 children with GMFCS I, 1 child with GMFCS III, 1 child with GMFCS IV and 2 GMFCS V children. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM
GROSS MOTOR FUNCTION MEASURE (Scale for gross mobility) (scoring 0%-100%)
Measured: 9 months
PEDI
PEDIATRIC EVALUATION OF DISABILITY INVENTORY (Scale for assess the daily life activities) (scoring 0%-100%)
Measured: 9 months
PBS
PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)
Measured: 9 months
TUG
TIMED UP AND GO (Scale to asses speed) (the minimoum time the better)
Measured: 9 months
WOTA 1
WATER ORIENTATION TEST ALYN 1 (Aquatic Scale to asses adaptation in water environment) (Aquatic Score 0- 52)
Measured: 9 MONTHS
WOTA 2
WATER ORIENTATION TEST ALYN 12 (Aquatic Scale to asses adaptation in water environment) ( Score 0-81)
Measured: 9 months
SWIM
SWIM WITH INDEPENDENT MEASURE (Aquatic Scale to asses adaptation in water environment) (Score 0-71)
Measured: 9 months
HAAR
HUMPHRIES' ASSESSMENT OF AQUATIC READINESS (Aquatic Scale to asses adaptation in water environment)(Score 0-34)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2022
- Primary completion26 May 2024 (estimated)
- Study completion5 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups, 80 children with CP 1. group: Intervention in water- halliwick, 40 children 2. group: On land therapy- bobath, 40 children 3. group: No intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Chandolias, University of Thessaly
- Investigators
- Athanasios Tsiokanos, Dr, Study director, Univesity of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770298
- Sponsor's protocol ID
- 14018003112
- Status last verified
- May 2024
- First submitted
- 20 Feb 2021
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dimitrijevic L, Aleksandrovic M, Madic D, Okicic T, Radovanovic D, Daly D. The effect of aquatic intervention on the gross motor function and aquatic skills in children with cerebral palsy. J Hum Kinet. 2012 May;32:167-74. doi: 10.2478/v10078-012-0033-5. Epub 2012 May 30.
PubMed 23487257
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Bobath Neurodevelopmental Treatment and Halliwick Concept Hydrotherapy in the Treatment of Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04770298
- Acronym / sponsor ID
- 14018003112
- Conditions
- Cerebral Palsy
- Keywords
- aquatic therapy, pediatrics, cerebral palsy, Bobath, Halliwick
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 26 May 2024 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the effectiveness of water based therapy on children with Cerebral Palsy (CP)
Detailed description
The purpose of this randomized controlled trial was:
To examine the effectiveness of the Halliwick concept intervention in water approach for people with motor deficiency and, more specifically, for children with diagnosed cerebral palsy.
In a second phase, to compare the contribution of water intervention to the child's motor development against just Bobath physiotherapeutic intervention, in terms of the milestones of gross motor skills of the children over time.
The aim of the research is to determine the contribution of the Halliwick Concept- Hydrotherapeutic Intervention approach in the psychomotor development in children with cerebral palsy and to explore its contribution to a comprehensive therapeutic approach for these children. It is a fact that, in recent years, parallel therapeutic approaches have gained ground, which, in combination with the physiotherapeutic treatment, contributes to the enhancement of therapeutic effects in early and follow-up intervention for children with cerebral palsy.
The study resulted from the fact that there is not such a large-scale study in Greece. Also, there are few published studies in the world, trying to evaluate the therapeutic benefit of the Halliwick Concept as an hydro-therapeutic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups, 80 children with CP 1. group: Intervention in water- halliwick, 40 children 2. group: On land therapy- bobath, 40 children 3. group: No intervention
| Arm | Type | Receives |
|---|---|---|
| Halliwick Assessment Group | Experimental | Other: Halliwick Concept8 children with GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM (GMFCS) I, 13 children with GMFCS II, 7 GMFCS III children, 8 GMFCS IV children and 4 children with GMFCS V. Intervention in water environment (Halliwick Concept), 1 times/week- 1 intervention on land/week, 9 months duration. |
| Bobath Assessment Group | Experimental | Other: Halliwick Concept7 children with GMFCS I, 12 children with GMFCS II, 8 children with GMFCS III, 6 children with GMFCS IV and 2 children with GMFCS V. Intervention on land ( Bobath), 2 times/week, 9 months duration. |
| No intervention group | No intervention | –1 children with GMFCS I, 1 child with GMFCS III, 1 child with GMFCS IV and 2 GMFCS V children. No intervention. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with Cerebral Palsy
- Not have some type of surgery or botulinum toxin infusion in the last year.
- The children with cognitive limitations were selected, in order to be able to execute elementary commands.
- Attending treatment program by the same therapist, either on water, or on land.
Key exclusion criteria (5 listed)
- Children with autism
- Children who had some scheduled surgery or botulinum toxin injection.
- Children with severe vision problems
- Children who could not follow the verbal instructions or reproduce a test reproduction.
- Children who were absent from the treatment program either in the water or on land for over a week
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 |
|---|---|---|
| Halliwick ConceptAlso: Bobath ConceptHalliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment | Other | Bobath Assessment Group, Halliwick Assessment Group |
Primary outcome
GMFM
Time frame: 9 months
GROSS MOTOR FUNCTION MEASURE (Scale for gross mobility) (scoring 0%-100%)
PEDI
Time frame: 9 months
PEDIATRIC EVALUATION OF DISABILITY INVENTORY (Scale for assess the daily life activities) (scoring 0%-100%)
PBS
Time frame: 9 months
PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)
TUG
Time frame: 9 months
TIMED UP AND GO (Scale to asses speed) (the minimoum time the better)
WOTA 1
Time frame: 9 MONTHS
WATER ORIENTATION TEST ALYN 1 (Aquatic Scale to asses adaptation in water environment) (Aquatic Score 0- 52)
WOTA 2
Time frame: 9 months
WATER ORIENTATION TEST ALYN 12 (Aquatic Scale to asses adaptation in water environment) ( Score 0-81)
SWIM
Time frame: 9 months
SWIM WITH INDEPENDENT MEASURE (Aquatic Scale to asses adaptation in water environment) (Score 0-71)
HAAR
Time frame: 9 months
HUMPHRIES' ASSESSMENT OF AQUATIC READINESS (Aquatic Scale to asses adaptation in water environment)(Score 0-34)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Background: PubMed 23487257Dimitrijevic L, Aleksandrovic M, Madic D, Okicic T, Radovanovic D, Daly D. The effect of aquatic intervention on the gross motor function and aquatic skills in children with cerebral palsy. J Hum Kinet. 2012 May;32:167-74. doi: 10.2478/v10078-012-0033-5. Epub 2012 May 30.
- Individual participant dataSharing planned: No
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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.
Athanasios Tsiokanos, Dr study director
Univesity of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halliwick Concept in people with Cerebral Palsy, run by University of Thessaly at 1 site in Greece.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 May 2024. 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 Greece. 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?
Results are not available in the source record.
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?
GMFM (time frame: 9 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770298, which also lists 1 linked publication.
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 28 May 2024.