NCT05091892

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

October 21, 2021

Last Update Submit

November 2, 2022

Conditions

Cerebral Palsy

Keywords

Cerebral palsyhydrotherapyNeurodevelopmental treatmentLying downSitting

Outcome Measures

Primary Outcomes (2)

  • GMFM

    Gross Motor Function Measurement

    3 months

  • PBS

    Paediatric Balance test

    3 months

Study Arms (2)

Water Group

EXPERIMENTAL

Neurodevelopmental treatment

Other: Hydrotherapy programm

Land Group

EXPERIMENTAL

Lonqitudinal, transversal and compined rotation in a hydrotherapy programm

Other: Hydrotherapy programm

Interventions

Hydrotherapy programmOTHER

Treatment

Also known as: Neurodevelomental treatment
Land GroupWater Group

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cerebral palsy
  • DIfficulties from lying down to sitting posistion

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konstantinos Chandolias

Thessaloniki, 54635, Greece

Location

MeSH Terms

Conditions

Cerebral PalsyPressure Ulcer

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 equal groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Konstantinos Chandolias

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 25, 2021

Study Start

September 1, 2021

Primary Completion

November 30, 2021

Study Completion

March 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

GR(1)