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NCT Number: NCT06314776

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Gait Disorders in Children Hemiplegia Nervous System Diseases Neurologic Disorder Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María del Mar Sánchez-Joya

Almería, 04120, Spain

Location status: Recruiting

Location contact

María del Mar Sánchez-Joya, PhD

CONTACT

Pilar Pérez Guillén

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual physiotherapy without Whole-Body Vibration

Other

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

Pre-Usual physiotherapy

Other

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

Post-Usual physiotherapy

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria del Mar Sanchez Joya, PhD

CONTACT

[email protected]

627445787

Maria del Mar Sanchez Joya, PhD

CONTACT

627445787

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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