ClinicalTrials.gg
RecruitingNCT06314776Updated Dec 16, 2024

Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy

An interventional study of Usual physiotherapy without Whole-Body Vibration and Pre-Usual physiotherapy in Cerebral Palsy, Neurologic Disorder and Gait Disorders in Children, sponsored by Universidad de Almeria. Recruiting at 1 site in Spain. Open to participants aged 2 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
2 Years to 11 Years
Sex
All
01

Study summary

Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution

02

Conditions studied

  • Cerebral Palsy
  • Neurologic Disorder
  • Gait Disorders in Children
  • Hemiplegia

Keywords

  • Cerebral Palsy
  • Whole-Body Vibration
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 10 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of neurological developmental disorder: Cerebral Palsy. (According to )
  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    Pre-Usual physiotherapy

    Pre-intervention (GMFM, Test 10M, Test Time Up and Go)

    Other: Pre-Usual physiotherapy

  • Active comparator
    Usual physiotherapy without Whole-Body Vibration

    Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques)

    Other: Usual physiotherapy without Whole-Body Vibration

  • Active comparator
    Post-Usual physiotherapy

    Post-intervention (GMFM, Test 10M, Test Time Up and Go)

    Other: Post-Usual physiotherapy

Interventions

  • OtherUsual physiotherapy without Whole-Body Vibration

    Manual Therapy, passive and active mobilizations, stretching, respiratory techniques

  • OtherPre-Usual physiotherapy

    (GMFM, Test 10M, Test Time Up and Go)

  • OtherPost-Usual physiotherapy

    (GMFM, Test 10M, Test Time Up and Go)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One Month

  2. 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.

    Time frame: One Month

  3. 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.

    Time frame: One Month

07

Study locations

1 of 1 sites recruiting
  • María del Mar Sánchez-Joya
    Almería, 04120, Spain
    Recruiting
    • María del Mar Sánchez-Joya, PhD · Contact
    • Pilar Pérez Guillén · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — The data that support the findings of this study are available from the corresponding author upon reasonable request.

Supporting information: Statistical analysis plan

Time frame: Data will become available for one year once the study is finished

Access criteria: Reasonable request to reproduce the intervention performed on this study

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Jun 2025, 14 months after the start.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 14 months is above that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2024
First posted
Mar 18, 2024
StartActual
Mar 11, 2024
Primary completionEst.
Jun 1, 2025
CompletionEst.
Sep 30, 2025
Last update
Dec 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06314776
Lead sponsor
Universidad de Almeria
Responsible party
María del Mar Sánchez Joya (Associate Professor, Universidad de Almeria) — Principal investigator
First posted
Mar 18, 2024
Start date
Mar 11, 2024
Primary completion
Jun 1, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Dec 16, 2024

Study contacts

Maria del Mar Sanchez Joya, PhD
Contact
msj260@ual.es
627445787
Maria del Mar Sanchez Joya, PhD
Contact
627445787

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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