NCT05134844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

November 11, 2021

Last Update Submit

November 24, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Study Arms (2)

Halliwick Snoezelen Group

EXPERIMENTAL

Hydrotherapy in a multi-sensory Snoezelen environment

Other: Hydrotherapy- SnoezelenOther: Snoezelen

Land Snoezelen Group

EXPERIMENTAL

Land multi-sensory Snoezelen environment

Other: Hydrotherapy- SnoezelenOther: Snoezelen

Interventions

Multi sensory approach in water

Halliwick Snoezelen GroupLand Snoezelen Group

Multu Sensory approach on land

Halliwick Snoezelen GroupLand Snoezelen Group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Lamía, Central Macedonia, 35100, Greece

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderSensation Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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,
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc researcher Dr Konstantinos Chandolias

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 26, 2021

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations