- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134844
Halliwick Hydrotherapy and Snoezelen
November 24, 2021 updated by: Konstantinos Chandolias, University of Thessaly
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central Macedonia
-
Lamía, Central Macedonia, Greece, 35100
- University of Thessaly
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Halliwick Snoezelen Group
Hydrotherapy in a multi-sensory Snoezelen environment
|
Multi sensory approach in water
Multu Sensory approach on land
|
|
Experimental: Land Snoezelen Group
Land multi-sensory Snoezelen environment
|
Multi sensory approach in water
Multu Sensory approach on land
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
November 11, 2021
First Submitted That Met QC Criteria
November 24, 2021
First Posted (Actual)
November 26, 2021
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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