Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Effectiveness of the Bobath Neurodevelopmental Treatment and Halliwick Concept Hydrotherapy in the Treatment of Children With Cerebral Palsy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04770298
• Other study ID #: 14018003112
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 5, 2024

Study information

• Verified date: May 2024
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: June 5, 2024
• Est. primary completion date: May 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Halliwick Concept
Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment

Locations

Country	Name	City	State
Greece	University of Thessaly	Lamía	Central Macedonia

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMFM	GROSS MOTOR FUNCTION MEASURE (Scale for gross mobility) (scoring 0%-100%)	9 months
Primary	PEDI	PEDIATRIC EVALUATION OF DISABILITY INVENTORY (Scale for assess the daily life activities) (scoring 0%-100%)	9 months
Primary	PBS	PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)	9 months
Primary	TUG	TIMED UP AND GO (Scale to asses speed) (the minimoum time the better)	9 months
Primary	WOTA 1	WATER ORIENTATION TEST ALYN 1 (Aquatic Scale to asses adaptation in water environment) (Aquatic Score 0- 52)	9 MONTHS
Primary	WOTA 2	WATER ORIENTATION TEST ALYN 12 (Aquatic Scale to asses adaptation in water environment) ( Score 0-81)	9 months
Primary	SWIM	SWIM WITH INDEPENDENT MEASURE (Aquatic Scale to asses adaptation in water environment) (Score 0-71)	9 months
Primary	HAAR	HUMPHRIES' ASSESSMENT OF AQUATIC READINESS (Aquatic Scale to asses adaptation in water environment)(Score 0-34)	9 months