Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy

NCT04770298 | Active Not Recruiting DMC

• 1 other identifier: 14018003112
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Keywords

aquatic therapy; pediatrics; cerebral palsy; Bobath; Halliwick

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

Halliwick Assessment Group

EXPERIMENTAL

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.

Other: Halliwick Concept

Bobath Assessment Group

EXPERIMENTAL

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.

Other: Halliwick Concept

No intervention group

NO INTERVENTION

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

Interventions

Halliwick Concept OTHER

Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment

Also known as: Bobath Concept

Bobath Assessment Group; Halliwick Assessment Group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University of Thessaly

Lamía, Central Macedonia, 35100, Greece

Location

Related 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.

  PMID: 23487257 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Athanasios Tsiokanos, Dr

  Univesity of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 25, 2021
• Study Start: September 1, 2022
• Primary Completion: May 26, 2024
• Study Completion: June 5, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)