Clinical trial NCT04770298: Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy
Official title: The Effectiveness of the Bobath Neurodevelopmental Treatment and Halliwick Concept Hydrotherapy in the Treatment of Children With Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: aquatic therapy
pediatrics
cerebral palsy
Bobath
Halliwick
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 85
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: GMFM
timeFrame: 9 months
measure: PEDI
timeFrame: 9 months
measure: PBS
timeFrame: 9 months
measure: TUG
timeFrame: 9 months
measure: WOTA 1
timeFrame: 9 MONTHS
measure: WOTA 2
timeFrame: 9 months
measure: SWIM
timeFrame: 9 months
measure: HAAR
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lamía
country: Greece
facility: University of Thessaly
state: Central Macedonia
Study officials:
affiliation: Univesity of Thessaly
name: Athanasios Tsiokanos, Dr
role: STUDY_DIRECTOR
References:
citation: 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.