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Clinical Trial NCT04770298 for Cerebral Palsy is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy 85
Clinical Trial NCT04770298 is an interventional study for Cerebral Palsy that is active, not recruiting. It started on 1 September 2022 with plans to enroll 85 participants. Led by University of Thessaly, it is expected to complete by 5 June 2024. The latest data from ClinicalTrials.gov was last updated on 28 May 2024.
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 milestone...
Show MoreOfficial Title
The Effectiveness of the Bobath Neurodevelopmental Treatment and Halliwick Concept Hydrotherapy in the Treatment of Children With Cerebral Palsy.
Conditions
Cerebral PalsyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 14018003112
NCT ID Number
Start Date (Actual)
2022-09-01
Last Update Posted
2024-05-28
Completion Date (Estimated)
2024-06-05
Enrollment (Estimated)
85
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
aquatic therapy
pediatrics
cerebral palsy
Bobath
Halliwick
pediatrics
cerebral palsy
Bobath
Halliwick
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHalliwick 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. | Halliwick Concept Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment |
ExperimentalBobath 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. | Halliwick Concept Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment |
No InterventionNo intervention group 1 children with GMFCS I, 1 child with GMFCS III, 1 child with GMFCS IV and 2 GMFCS V children. No intervention. | N/A |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
GMFM | GROSS MOTOR FUNCTION MEASURE (Scale for gross mobility) (scoring 0%-100%) | 9 months |
PEDI | PEDIATRIC EVALUATION OF DISABILITY INVENTORY (Scale for assess the daily life activities) (scoring 0%-100%) | 9 months |
PBS | PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56) | 9 months |
TUG | TIMED UP AND GO (Scale to asses speed) (the minimoum time the better) | 9 months |
WOTA 1 | WATER ORIENTATION TEST ALYN 1 (Aquatic Scale to asses adaptation in water environment) (Aquatic Score 0- 52) | 9 MONTHS |
WOTA 2 | WATER ORIENTATION TEST ALYN 12 (Aquatic Scale to asses adaptation in water environment) ( Score 0-81) | 9 months |
SWIM | SWIM WITH INDEPENDENT MEASURE (Aquatic Scale to asses adaptation in water environment) (Score 0-71) | 9 months |
HAAR | HUMPHRIES' ASSESSMENT OF AQUATIC READINESS (Aquatic Scale to asses adaptation in water environment)(Score 0-34) | 9 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All
- 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.
- 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
Study Responsible Party
Konstantinos Chandolias, Principal Investigator, Principal Investigator, University of Thessaly
No contact data.
1 Study Locations in 1 Countries
Central Macedonia
University of Thessaly, Lamía, Central Macedonia, 35100, Greece