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Hydrotherapy CP and Lying Down to Sitting Position

Sponsor
University of Thessaly (Other)
Overall Status
Recruiting
CT.gov ID
NCT05091892
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
6.9
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of a very specific hydrotherapy programm on the movement from lying down to sitting position for children with CP

Condition or Disease Intervention/Treatment Phase
  • Other: Hydrotherapy programm
 N/A

Detailed Description

40 children aged 5-11 years with cerebral palsy and difficulty in the transfer activity from lying down to sitting position were randomly divided into 2 groups of 20 children, a land group and a water group. The children of the land attended a neurodevelopmental treatment program and the water group a very specific program in hydrotherapy on combined rotation at all levels. The water program was implemented by specialized physiotherapists in hydrotherapy. The duration of the program for both groups was 3 months. On the first and last day of the intervention, an evaluation of all children was performed using the GMFM and PBS evaluation tests of the evaluation parameters of the transfer from the lying position to the sitting position.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 equal groups2 equal groups
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of a Specific Hydrotherapy Program on the Movement From Lying Down to Sitting Position for Children With Cerebral Palsy
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Mar 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Water Group

Neurodevelopmental treatment

Other: Hydrotherapy programm
Treatment
Other Names:
  • Neurodevelomental treatment

    		•
    Experimental: Land Group

    Lonqitudinal, transversal and compined rotation in a hydrotherapy programm

    Other: Hydrotherapy programm
    Treatment
    Other Names:
  • Neurodevelomental treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. GMFM [3 months]

      Gross Motor Function Measurement

    2. PBS [3 months]

      Paediatric Balance test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Cerebral palsy

    • DIfficulties from lying down to sitting posistion

    Exclusion Criteria:

    • Surgery or injection of botilium toxin in the last year.

    • Scheduled surgery or injection of botilium toxin.

    • Uncontrolled seizures.

    • Do not run elementary commands or play a test representation.

    • Autism.

    • Syndromes without OP.

    • Serious vision problem.

    • Absence from the treatment program for more than a week.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konstantinos Chandolias Thessaloniki Greece 54635

    Sponsors and Collaborators

    • University of Thessaly

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Konstantinos Chandolias, Dr Konstantinos Chandolias, University of Thessaly
    ClinicalTrials.gov Identifier:
    NCT05091892
    Other Study ID Numbers:
    • KC140180
    First Posted:
    Oct 25, 2021
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Konstantinos Chandolias, Dr Konstantinos Chandolias, University of Thessaly
    Cerebral palsy
    hydrotherapy
    Neurodevelopmental treatment
    Lying down
    Sitting
    Additional relevant MeSH terms:
    Cerebral Palsy

    Study Results

    No Results Posted as of Jan 21, 2022