Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy
1 other identifier
interventional
10
1 country
1
Brief Summary
Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2024
CompletedStudy Start
First participant enrolled
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedDecember 16, 2024
December 1, 2024
1.2 years
March 9, 2024
December 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
Pre-Usual physiotherapy
ACTIVE COMPARATORPre-intervention (GMFM, Test 10M, Test Time Up and Go)
Usual physiotherapy without Whole-Body Vibration
ACTIVE COMPARATORTwo days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques)
Post-Usual physiotherapy
ACTIVE COMPARATORPost-intervention (GMFM, Test 10M, Test Time Up and Go)
Interventions
Manual Therapy, passive and active mobilizations, stretching, respiratory techniques
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
María del Mar Sánchez-Joya
Almería, 04120, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 9, 2024
First Posted
March 18, 2024
Study Start
March 11, 2024
Primary Completion
June 1, 2025
Study Completion
September 30, 2025
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- 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
The data that support the findings of this study are available from the corresponding author upon reasonable request.