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Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Halliwick Concept
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring aquatic therapy, pediatrics, cerebral palsy, Bobath, Halliwick

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Halliwick Assessment Group

    Bobath Assessment Group

    No intervention group

    Arm Description

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2021
    Last Updated
    February 25, 2021
    Sponsor
    University of Thessaly
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04770298
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    July 1, 2017 (Actual)
    Study Completion Date
    July 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Thessaly

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    aquatic therapy, pediatrics, cerebral palsy, Bobath, Halliwick

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    3 groups, 80 children with CP group: Intervention in water- halliwick, 40 children group: On land therapy- bobath, 40 children group: No intervention
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    85 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Halliwick Assessment Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Bobath Assessment Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No intervention group
    Arm Type
    No Intervention
    Arm Description
    1 children with GMFCS I, 1 child with GMFCS III, 1 child with GMFCS IV and 2 GMFCS V children. No intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Halliwick Concept
    Other Intervention Name(s)
    Bobath Concept
    Intervention Description
    Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment
    Primary Outcome Measure Information:
    Title
    GMFM
    Description
    GROSS MOTOR FUNCTION MEASURE (Scale for gross mobility) (scoring 0%-100%)
    Time Frame
    9 months
    Title
    PEDI
    Description
    PEDIATRIC EVALUATION OF DISABILITY INVENTORY (Scale for assess the daily life activities) (scoring 0%-100%)
    Time Frame
    9 months
    Title
    PBS
    Description
    PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)
    Time Frame
    9 months
    Title
    TUG
    Description
    TIMED UP AND GO (Scale to asses speed) (the minimoum time the better)
    Time Frame
    9 months
    Title
    WOTA 1
    Description
    WATER ORIENTATION TEST ALYN 1 (Aquatic Scale to asses adaptation in water environment) (Aquatic Score 0- 52)
    Time Frame
    9 MONTHS
    Title
    WOTA 2
    Description
    WATER ORIENTATION TEST ALYN 12 (Aquatic Scale to asses adaptation in water environment) ( Score 0-81)
    Time Frame
    9 months
    Title
    SWIM
    Description
    SWIM WITH INDEPENDENT MEASURE (Aquatic Scale to asses adaptation in water environment) (Score 0-71)
    Time Frame
    9 months
    Title
    HAAR
    Description
    HUMPHRIES' ASSESSMENT OF AQUATIC READINESS (Aquatic Scale to asses adaptation in water environment)(Score 0-34)
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Athanasios Tsiokanos, Dr
    Organizational Affiliation
    Univesity of Thessaly
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23487257
    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.
    Results Reference
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    Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy

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