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

Not Applicable

Recruiting

• Conditions: Gait Disorders in Children; Neurologic Disorder; Hemiplegia; Cerebral Palsy
• Interventions: Other: Pre-Usual physiotherapy; Other: Post-Usual physiotherapy; Other: Usual physiotherapy without Whole-Body Vibration

• Registration Number: NCT06314776
• Lead Sponsor: Universidad de Almeria

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-09
• Study Start: 2024-03-11
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Usual physiotherapy	Pre-Usual physiotherapy	Pre-intervention (GMFM, Test 10M, Test Time Up and Go)
Post-Usual physiotherapy	Post-Usual physiotherapy	Post-intervention (GMFM, Test 10M, Test Time Up and Go)
Usual physiotherapy without Whole-Body Vibration	Usual physiotherapy without Whole-Body Vibration	Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques)

Primary Outcome Measures

Name	Time	Method
Test Time Up and Go	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	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	One Month	This scale consists of an 88 items test to assess gross motor function, as higher score have the children better physical condition.

Trial Locations

Locations (1)

María del Mar Sánchez-Joya; 🇪🇸 Almería, Spain