Autism Spectrum DisorderNCT05134844
Halliwick Hydrotherapy and Snoezelen
A study testing Hydrotherapy- Snoezelen and Snoezelen in people with Autism Spectrum Disorder and Autism, run by University of Thessaly at 1 site in Greece.
Trial summary
The aim of this study was to evaluate the effectiveness of the Halliwick concept in the adapted Snoezelen multi-sensory environment, in the gross mobility of children belonging to the autism spectrum. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Sensory Disorder
- What is being tested?
- Hydrotherapy- Snoezelen and Snoezelen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2021to 1 May 2021
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-8 years with autism
- All participants had the criterion of participation in the monitoring treatment program by the same therapist either in water or on land.
Who cannot join
- Children with other neurological diseases were excluded.
- Children who had some scheduled surgery were also excluded intervention or injection of sausage toxin.
- Children who were absent from the treatment program were excluded either in water or on land for more than a week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Halliwick Hydrotherapy in Snoezelen Multisensory Environment and Snoezelen Intervention in Children With Autism
The aim of this study was to evaluate the effectiveness of the Halliwick concept in the adapted Snoezelen multi-sensory environment, in the gross mobility of children belonging to the autism spectrum.
Read the detailed description
The study involved 54 children, aged 4 to 8, all of whom belonged to the autism spectrum (ASD) and all had cognitive limitations. The duration of the intervention was 3 months by specialized pediatric physiotherapists and hydrotherapists certified by the program "PEDIATRIC SPECIALIZATION" and NDT- BOBATH. All children were assessed through the WOTA 1 and PEDI assessment tests.
- Conditions
- Autism Spectrum Disorder, Autism, Sensory Disorder
- Being tested
- Hydrotherapy- Snoezelen, Snoezelen
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrotherapy- SnoezelenOther
Multi sensory approach in water
SnoezelenOther
Multu Sensory approach on land
| Study group | Role | What they receive |
|---|---|---|
| Halliwick Snoezelen Group | Experimental | Hydrotherapy in a multi-sensory Snoezelen environment Receives: Other: Hydrotherapy- Snoezelen; Other: Snoezelen |
| Land Snoezelen Group | Experimental | Land multi-sensory Snoezelen environment Receives: Other: Hydrotherapy- Snoezelen; Other: Snoezelen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Disability and Activity- PEDI
Pediatric Evaluation of Disability Inventory assesses key functional capabilities and performance in children ages 6 months to 7 years. PEDI is also useful for older children whose functional abilities are lower than those of seven-year-olds without disabilities.
Measured: 3 months
Adaptation and progression in pool- WOTA
Water Orientation test Alyn- Wota is an assessment scale to evaluate the progress of a patient in the water enviroment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Feb 2021
- Primary completion1 Apr 2021
- Study completion1 May 2021
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 Autism Spectrum DisorderStudies 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
- The design of the present study included two groups of children with autism. A first group of 26 children formed the core group with the Halliwick philosophy - hydrotherapy in water in a multi-sensory Snoezelen environment. A second group of 27 children was the Snoezelen on-site control-intervention group with two sessions per week, which was the measure of comparison and support of "reasonable" hypotheses, in order to evaluate the hypothesis that Halliwick hydrotherapy in a multi-sensory environment in combination with intervention on land leads to better therapeutic results. The application of the tests was done by the 2 examiners, who were pediatric physiotherapists - hydrotherapists with many years of experience (more than 10 years) in approaching motor problems of children with stroke. The tests were videotaped and then graded by the two examiners separately, which was considered important in order to ensure the objective grading of the assessment tests.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134844
- Sponsor's protocol ID
- 36469
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Ager, A., & O'May, F. (2001). Issues in the definition and implementation of ''best practice'' for staff delivery of interventions for challenging behaviour. Journal of Intellectual & Developmental Disability, 26, 243-256. 2. American Academy of Child and Adolescent Psychiatry. Practice Parameters for the assessment and treatment of Children, Adolescents and Adults with Autism and Other Pervasive Developmental Disorders. 1999, 38(12) Supplement, 32S-54S. 3. American Psychiatric Association. Autism spectrum disorder. In: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association, Arlington, VA 2013. p.50 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders,4th edition(DSM-IV).Washington, DC 1994: American Psychiatric Association. 5. Anderson GM, Hoshiono Y. Neurochemical studies of autism. In: Cohen DJ, Volkmar FR (eds) Handbook of Autism and Pervasive Developmental Disorders. New York: Wiley, 1997, pp. 325-343. 6. Ashby, M., Broxholme, S., Pitcaithly, D., & Lindsay, W. R. (1995). Snoezelen: Its effects on concentration and responsiveness in people with profound multiple handicaps. British Journal of Occupational Therapy, 58, 303-307. 7. Atari, R. (2014). The Influence of Multi-Sensory Environment on Physiological Response in Children with Autism Spectrum Disorders and Children with Special Health Care Needs. Marquette University. 8. Bailey A & Lord C. Autism Spectrum Disorder. In M. Rutter & E. Taylor (eds) Child and Adolescent Psychiatry 4th Edition. Oxford: Blackwell Publishing 2002, pp. 636-663. 9. Bailey A, Le Couteur A, Gottesman I et al. Autism as a strongly genetic disorder: evidence from a British twin study. Psychological Medicine, 1995, 25: 63-77. 10. Bailey A, Palferman S, Heavey L, Le Couteur A. Autism: the phenotype in relatives. Journal of Autism and Developmental Disorders, 1998, 28(5): 369-392.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Halliwick Hydrotherapy in Snoezelen Multisensory Environment and Snoezelen Intervention in Children With Autism
- ClinicalTrials.gov ID
- NCT05134844
- Acronym / sponsor ID
- 36469
- Conditions
- Autism Spectrum Disorder, Autism, Sensory Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Nov 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.
The aim of this study was to evaluate the effectiveness of the Halliwick concept in the adapted Snoezelen multi-sensory environment, in the gross mobility of children belonging to the autism spectrum.
Detailed description
The study involved 54 children, aged 4 to 8, all of whom belonged to the autism spectrum (ASD) and all had cognitive limitations. The duration of the intervention was 3 months by specialized pediatric physiotherapists and hydrotherapists certified by the program "PEDIATRIC SPECIALIZATION" and NDT- BOBATH. All children were assessed through the WOTA 1 and PEDI assessment tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The design of the present study included two groups of children with autism. A first group of 26 children formed the core group with the Halliwick philosophy - hydrotherapy in water in a multi-sensory Snoezelen environment. A second group of 27 children was the Snoezelen on-site control-intervention group with two sessions per week, which was the measure of comparison and support of "reasonable" hypotheses, in order to evaluate the hypothesis that Halliwick hydrotherapy in a multi-sensory environment in combination with intervention on land leads to better therapeutic results. The application of the tests was done by the 2 examiners, who were pediatric physiotherapists - hydrotherapists with many years of experience (more than 10 years) in approaching motor problems of children with stroke. The tests were videotaped and then graded by the two examiners separately, which was considered important in order to ensure the objective grading of the assessment tests.
| Arm | Type | Receives |
|---|---|---|
| Halliwick Snoezelen Group | Experimental | Other: Hydrotherapy- Snoezelen, Other: SnoezelenHydrotherapy in a multi-sensory Snoezelen environment |
| Land Snoezelen Group | Experimental | Other: Hydrotherapy- Snoezelen, Other: SnoezelenLand multi-sensory Snoezelen environment |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 4-8 years with autism
- All participants had the criterion of participation in the monitoring treatment program by the same therapist either in water or on land.
Key exclusion criteria (3 listed)
- Children with other neurological diseases were excluded.
- Children who had some scheduled surgery were also excluded intervention or injection of sausage toxin.
- Children who were absent from the treatment program were excluded either in water or on land for more than 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 |
|---|---|---|
| Hydrotherapy- SnoezelenMulti sensory approach in water | Other | Halliwick Snoezelen Group, Land Snoezelen Group |
| SnoezelenMultu Sensory approach on land | Other | Halliwick Snoezelen Group, Land Snoezelen Group |
Primary outcome
Evaluation of Disability and Activity- PEDI
Time frame: 3 months
Pediatric Evaluation of Disability Inventory assesses key functional capabilities and performance in children ages 6 months to 7 years. PEDI is also useful for older children whose functional abilities are lower than those of seven-year-olds without disabilities.
Adaptation and progression in pool- WOTA
Time frame: 3 months
Water Orientation test Alyn- Wota is an assessment scale to evaluate the progress of a patient in the water enviroment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Background1. Ager, A., & O'May, F. (2001). Issues in the definition and implementation of ''best practice'' for staff delivery of interventions for challenging behaviour. Journal of Intellectual & Developmental Disability, 26, 243-256. 2. American Academy of Child and Adolescent Psychiatry. Practice Parameters for the assessment and treatment of Children, Adolescents and Adults with Autism and Other Pervasive Developmental Disorders. 1999, 38(12) Supplement, 32S-54S. 3. American Psychiatric Association. Autism spectrum disorder. In: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association, Arlington, VA 2013. p.50 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders,4th edition(DSM-IV).Washington, DC 1994: American Psychiatric Association. 5. Anderson GM, Hoshiono Y. Neurochemical studies of autism. In: Cohen DJ, Volkmar FR (eds) Handbook of Autism and Pervasive Developmental Disorders. New York: Wiley, 1997, pp. 325-343. 6. Ashby, M., Broxholme, S., Pitcaithly, D., & Lindsay, W. R. (1995). Snoezelen: Its effects on concentration and responsiveness in people with profound multiple handicaps. British Journal of Occupational Therapy, 58, 303-307. 7. Atari, R. (2014). The Influence of Multi-Sensory Environment on Physiological Response in Children with Autism Spectrum Disorders and Children with Special Health Care Needs. Marquette University. 8. Bailey A & Lord C. Autism Spectrum Disorder. In M. Rutter & E. Taylor (eds) Child and Adolescent Psychiatry 4th Edition. Oxford: Blackwell Publishing 2002, pp. 636-663. 9. Bailey A, Le Couteur A, Gottesman I et al. Autism as a strongly genetic disorder: evidence from a British twin study. Psychological Medicine, 1995, 25: 63-77. 10. Bailey A, Palferman S, Heavey L, Le Couteur A. Autism: the phenotype in relatives. Journal of Autism and Developmental Disorders, 1998, 28(5): 369-392.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy- Snoezelen and Snoezelen in people with Autism Spectrum Disorder and Autism, 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 2 inclusion and 3 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 26 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of Disability and Activity- PEDI (time frame: 3 months). The study lists 2 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 NCT05134844, 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 26 Nov 2021.