Cerebral PalsyNCT06314776
Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy
A study testing Usual physiotherapy without Whole-Body Vibration, Pre-Usual physiotherapy and Post-Usual physiotherapy in people with Cerebral Palsy and Neurologic Disorder, run by Universidad de Almeria at 1 site in Spain.
Trial summary
Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution Read more about this study
- Who is it for?
- Ages 2 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Neurologic Disorder, Gait Disorders in Children
- What is being tested?
- Usual physiotherapy without Whole-Body Vibration, Pre-Usual physiotherapy and Post-Usual physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of neurological developmental disorder: Cerebral Palsy. (According to DSM-V)
- Age between 2 to 11 years.
- GMFCS I and II.
- Assessed and/or intervened in or from centers, institutions, etc. who collaborate with the University of Almería or participate in them. Specifically from the "Interactúa" Child Development and Early Care Center.
- The subject, father/mother/legal guardian of each subject, prior to inclusion in the study, must have signed the informed consent for the participation of himself or his/her child in it, leaving a record that it could be abandoned if at any time they deem it appropriate and without having to justify it.
Who cannot join
- Diagnosis of Epilepsy.
- Serious blood circulation problems.
- Recent operations.
- Prosthetics.
- Start of another type of therapy different from the current one.
- Not having indication for Physiotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria del Mar Sanchez Joya, PhD contact
Spain1 site, 1 recruiting
- Recruiting
María del Mar Sánchez-Joya
Almería, 04120
María del Mar Sánchez-Joya, PhD
Pilar Pérez Guillén
About this study
Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution
- Being tested
- Usual physiotherapy without Whole-Body Vibration, Pre-Usual physiotherapy, Post-Usual physiotherapy
- Keywords
- Cerebral Palsy, Whole-Body Vibration
- Medical subject headings
- Cerebral Palsy, Nervous System Diseases, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual physiotherapy without Whole-Body VibrationOther
Manual Therapy, passive and active mobilizations, stretching, respiratory techniques
Pre-Usual physiotherapyOther
(GMFM, Test 10M, Test Time Up and Go)
Post-Usual physiotherapyOther
(GMFM, Test 10M, Test Time Up and Go)
| Study group | Role | What they receive |
|---|---|---|
| Pre-Usual physiotherapy | Active comparator | Pre-intervention (GMFM, Test 10M, Test Time Up and Go) Receives: Other: Pre-Usual physiotherapy |
| Usual physiotherapy without Whole-Body Vibration | Active comparator | Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) Receives: Other: Usual physiotherapy without Whole-Body Vibration |
| Post-Usual physiotherapy | Active comparator | Post-intervention (GMFM, Test 10M, Test Time Up and Go) Receives: Other: Post-Usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Time Up and Go
The time it takes children to walk 3 metres, getting up from a standard chair walking to a cone and back and sitting back down is measured. The result of this scale is the time that the children take to do this, if the time decrease after the time of intervention that means the children improve their physical condition.
Measured: One Month
Timed 10-Meter Walk Test
The time traveled in seconds over a distance is measured, from the 2 meter mark to meter 8 is taken into consideration, three attempts are made by each participant. The result of this scale is the time that the children take to do this, if the time decrease after the time of intervention that means the children improve their physical condition.
Measured: One Month
Gross Motor Function Measure
This scale consists of an 88 items test to assess gross motor function, as higher score have the children better physical condition.
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start11 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Mar Sánchez Joya, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314776
- Sponsor's protocol ID
- NEURO24
- Status last verified
- Dec 2024
- First submitted
- 9 Mar 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06314776
- Acronym / sponsor ID
- NEURO24
- Keywords
- Cerebral Palsy, Whole-Body Vibration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Mar 2024 (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.
Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Usual physiotherapy | Active comparator | Other: Pre-Usual physiotherapyPre-intervention (GMFM, Test 10M, Test Time Up and Go) |
| Usual physiotherapy without Whole-Body Vibration | Active comparator | Other: Usual physiotherapy without Whole-Body VibrationTwo days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) |
| Post-Usual physiotherapy | Active comparator | Other: Post-Usual physiotherapyPost-intervention (GMFM, Test 10M, Test Time Up and Go) |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of neurological developmental disorder: Cerebral Palsy. (According to DSM-V)
- Age between 2 to 11 years.
- GMFCS I and II.
- Assessed and/or intervened in or from centers, institutions, etc. who collaborate with the University of Almería or participate in them. Specifically from the "Interactúa" Child Development and Early Care Center.
- The subject, father/mother/legal guardian of each subject, prior to inclusion in the study, must have signed the informed consent for the participation of himself or his/her child in it, leaving a record that it could be abandoned if at any time they deem it appropriate and without having to justify it.
Key exclusion criteria (6 listed)
- Diagnosis of Epilepsy.
- Serious blood circulation problems.
- Recent operations.
- Prosthetics.
- Start of another type of therapy different from the current one.
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 |
|---|---|---|
| Usual physiotherapy without Whole-Body VibrationManual Therapy, passive and active mobilizations, stretching, respiratory techniques | Other | Usual physiotherapy without Whole-Body Vibration |
| Pre-Usual physiotherapy(GMFM, Test 10M, Test Time Up and Go) | Other | Pre-Usual physiotherapy |
| Post-Usual physiotherapy(GMFM, Test 10M, Test Time Up and Go) | Other | Post-Usual physiotherapy |
Primary outcome
Test Time Up and Go
Time frame: One Month
The time it takes children to walk 3 metres, getting up from a standard chair walking to a cone and back and sitting back down is measured. The result of this scale is the time that the children take to do this, if the time decrease after the time of intervention that means the children improve their physical condition.
Timed 10-Meter Walk Test
Time frame: One Month
The time traveled in seconds over a distance is measured, from the 2 meter mark to meter 8 is taken into consideration, three attempts are made by each participant. The result of this scale is the time that the children take to do this, if the time decrease after the time of intervention that means the children improve their physical condition.
Gross Motor Function Measure
Time frame: One Month
This scale consists of an 88 items test to assess gross motor function, as higher score have the children better physical condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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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.
Maria del Mar Sanchez Joya, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual physiotherapy without Whole-Body Vibration, Pre-Usual physiotherapy and Post-Usual physiotherapy in people with Cerebral Palsy and Neurologic Disorder, run by Universidad de Almeria at 1 site in Spain.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria del Mar Sanchez Joya, PhD (627445787, msj260@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Time Up and Go (time frame: One Month). The study lists 3 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 16 Dec 2024.