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Hydrotherapy CP and Lying Down to Sitting Position

Primary Purpose

Cerebral Palsy

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

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring Cerebral palsy, hydrotherapy, Neurodevelopmental treatment, Lying down, Sitting

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Konstantinos Chandolias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Water Group

Land Group

Arm Description

Neurodevelopmental treatment

Lonqitudinal, transversal and compined rotation in a hydrotherapy programm

Outcomes

Primary Outcome Measures

GMFM
Gross Motor Function Measurement
PBS
Paediatric Balance test

Secondary Outcome Measures

Full Information

First Posted
October 21, 2021
Last Updated
November 2, 2022
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT05091892
Brief Title
Hydrotherapy CP and Lying Down to Sitting Position
Official Title
The Effect of a Specific Hydrotherapy Program on the Movement From Lying Down to Sitting Position for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 30, 2022 (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
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, hydrotherapy, Neurodevelopmental treatment, Lying down, Sitting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 equal groups
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water Group
Arm Type
Experimental
Arm Description
Neurodevelopmental treatment
Arm Title
Land Group
Arm Type
Experimental
Arm Description
Lonqitudinal, transversal and compined rotation in a hydrotherapy programm
Intervention Type
Other
Intervention Name(s)
Hydrotherapy programm
Other Intervention Name(s)
Neurodevelomental treatment
Intervention Description
Treatment
Primary Outcome Measure Information:
Title
GMFM
Description
Gross Motor Function Measurement
Time Frame
3 months
Title
PBS
Description
Paediatric Balance test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Konstantinos Chandolias
City
Thessaloniki
ZIP/Postal Code
54635
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hydrotherapy CP and Lying Down to Sitting Position

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