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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314776
• Other study ID #: NEURO24
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Universidad de Almeria
• Contact: Maria del Mar Sanchez Joya, PhD
• Phone: 627445787
• Email: msj260[@]ual.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders in Children
• Hemiplegia
• Nervous System Diseases
• Neurologic Disorder
• Paralysis

Intervention

Other:
• Usual physiotherapy without Whole-Body Vibration
Manual Therapy, passive and active mobilizations, stretching, respiratory techniques
• Pre-Usual physiotherapy
(GMFM, Test 10M, Test Time Up and Go)
• Post-Usual physiotherapy
(GMFM, Test 10M, Test Time Up and Go)

Locations

Country	Name	City	State
Spain	María del Mar Sánchez-Joya	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One Month
Primary	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.	One Month
Primary	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.	One Month