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

December 10, 2024 updated by: María del Mar Sánchez Joya, Universidad de Almeria
Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria del Mar Sanchez Joya, PhD
  • Phone Number: 627445787
  • Email: msj260@ual.es

Study Contact Backup

  • Name: Maria del Mar Sanchez Joya, PhD
  • Phone Number: 627445787

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Recruiting
        • María del Mar Sánchez-Joya
        • Contact:
          • María del Mar Sánchez-Joya, PhD
        • Sub-Investigator:
          • Pilar Pérez Guillén

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pre-Usual physiotherapy
Pre-intervention (GMFM, Test 10M, Test Time Up and Go)
Other: Pre-Usual physiotherapy
(GMFM, Test 10M, Test Time Up and Go)
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
Manual Therapy, passive and active mobilizations, stretching, respiratory techniques
Active Comparator: Post-Usual physiotherapy
Post-intervention (GMFM, Test 10M, Test Time Up and Go)
Other: Post-Usual physiotherapy
(GMFM, Test 10M, Test Time Up and Go)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One Month
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.
One Month
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.
One Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEURO24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study are available from the corresponding author upon reasonable request.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Reasonable request to reproduce the intervention performed on this study

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe