Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy

NCT ID: NCT04770298

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-06-05

Brief Summary

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Investigation of the effectiveness of water based therapy on children with Cerebral Palsy (CP)

Detailed Description

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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

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Halliwick Assessment Group

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.

Group Type EXPERIMENTAL

Halliwick Concept

Intervention Type OTHER

Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment

Bobath Assessment Group

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.

Group Type EXPERIMENTAL

Halliwick Concept

Intervention Type OTHER

Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment

No intervention group

1 children with GMFCS I, 1 child with GMFCS III, 1 child with GMFCS IV and 2 GMFCS V children. No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Halliwick Concept

Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment

Intervention Type OTHER

Other Intervention Names

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Bobath Concept

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Chandolias

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athanasios Tsiokanos, Dr

Role: STUDY_DIRECTOR

Univesity of Thessaly

Locations

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University of Thessaly

Lamía, Central Macedonia, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 23487257 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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14018003112

Identifier Type: -

Identifier Source: org_study_id

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