Cerebral PalsyNCT05091892
Hydrotherapy CP and Lying Down to Sitting Position
A study testing Hydrotherapy programm in people with Cerebral Palsy, run by University of Thessaly at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hydrotherapy programm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral palsy
- DIfficulties from lying down to sitting posistion
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Specific Hydrotherapy Program on the Movement From Lying Down to Sitting Position for Children With Cerebral Palsy
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
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Hydrotherapy programm
- Keywords
- Cerebral palsy, hydrotherapy, Neurodevelopmental treatment, Lying down, Sitting
- Medical subject headings
- Cerebral Palsy, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrotherapy programmOther
Also called Neurodevelomental treatment
Treatment
| Study group | Role | What they receive |
|---|---|---|
| Water Group | Experimental | Neurodevelopmental treatment Receives: Other: Hydrotherapy programm |
| Land Group | Experimental | Lonqitudinal, transversal and compined rotation in a hydrotherapy programm Receives: Other: Hydrotherapy programm |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM
Gross Motor Function Measurement
Measured: 3 months
PBS
Paediatric Balance test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Nov 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 equal groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Chandolias, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091892
- Sponsor's protocol ID
- KC140180
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Specific Hydrotherapy Program on the Movement From Lying Down to Sitting Position for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05091892
- Acronym / sponsor ID
- KC140180
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, hydrotherapy, Neurodevelopmental treatment, Lying down, Sitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 equal groups
| Arm | Type | Receives |
|---|---|---|
| Water Group | Experimental | Other: Hydrotherapy programmNeurodevelopmental treatment |
| Land Group | Experimental | Other: Hydrotherapy programmLonqitudinal, transversal and compined rotation in a hydrotherapy programm |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Cerebral palsy
- DIfficulties from lying down to sitting posistion
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrotherapy programmAlso: Neurodevelomental treatmentTreatment | Other | Land Group, Water Group |
Primary outcome
GMFM
Time frame: 3 months
Gross Motor Function Measurement
PBS
Time frame: 3 months
Paediatric Balance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy programm in people with Cerebral Palsy, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMFM (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.