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Halliwick Hydrotherapy and Snoezelen

Primary Purpose

Autism Spectrum Disorder, Autism, Sensory Disorder

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Hydrotherapy- Snoezelen
Snoezelen
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Halliwick Snoezelen Group

Land Snoezelen Group

Arm Description

Hydrotherapy in a multi-sensory Snoezelen environment

Land multi-sensory Snoezelen environment

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2021
Last Updated
November 24, 2021
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT05134844
Brief Title
Halliwick Hydrotherapy and Snoezelen
Official Title
Comparison of the Effect of Halliwick Hydrotherapy in Snoezelen Multisensory Environment and Snoezelen Intervention in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism, Sensory Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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,
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Halliwick Snoezelen Group
Arm Type
Experimental
Arm Description
Hydrotherapy in a multi-sensory Snoezelen environment
Arm Title
Land Snoezelen Group
Arm Type
Experimental
Arm Description
Land multi-sensory Snoezelen environment
Intervention Type
Other
Intervention Name(s)
Hydrotherapy- Snoezelen
Intervention Description
Multi sensory approach in water
Intervention Type
Other
Intervention Name(s)
Snoezelen
Intervention Description
Multu Sensory approach on land
Primary Outcome Measure Information:
Title
Evaluation of Disability and Activity- PEDI
Description
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.
Time Frame
3 months
Title
Adaptation and progression in pool- WOTA
Description
Water Orientation test Alyn- Wota is an assessment scale to evaluate the progress of a patient in the water enviroment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Thessaly
City
Lamía
State/Province
Central Macedonia
ZIP/Postal Code
35100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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.
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Halliwick Hydrotherapy and Snoezelen

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