Effectiveness of Whole-Body Vibration

NCT ID: NCT06330311

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-29
• Study Completion Date: 2024-11-30

Brief Summary

Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas.

Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.

Detailed Description

Cerebral Palsy is the most common cause of severe physical disability in childhood (1.5 - 3 cases per thousand live births) and may or may not be accompanied by intellectual, sensory, communication deficits and epileptic syndromes depending on the brain region affected. The most frequent form of presentation is spastic cerebral palsy, characterized by atypical motor development, abnormal movement or posture, hyperreflexia, and increased muscle tone. These difficulties and limitations will have an impact on their independence and integration in all social areas.

The use of Whole-Body Vibration (WBV) to reduce spasticity of the lower limb and thereby improve functionality has been used for more than a decade showing some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The purpose of this randomized controlled trial is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.

Conditions

Spastic Cerebral Palsy; Physical Therapy Modalities; Vibration; Exposure; Lower Extremity Weakness, Spastic; Muscle Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Whole-Body Vibration Group

Allocated participants will receive an intervention with Whole-Body vibration (12 - 18 minutes, 12 - 20 hz, 1 - 2 mm progression) added to a physical therapy treatment based on learning and motor control through activities with a defined goal and therapeutic exercises (56 minutes per session) 4 sessions per week for 4 weeks.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

Evidence-based multimodal physiotherapy treatment based on learning and motor control

Control Group

Physical therapy treatment based on learning and motor control through activities with a defined goal and therapeutic exercises (56 minutes per session) 4 sessions per week for 4 weeks.

In the control group, the same measurements will be made at the same time as the subjects in the experimental group.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

Evidence-based multimodal physiotherapy treatment based on learning and motor control

Interventions

Physiotherapy

Evidence-based multimodal physiotherapy treatment based on learning and motor control

Intervention Type: OTHER

Other Intervention Names

Therapeutic exercise

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with spastic cerebral palsy.
• Aged between 8 and 14 years.
• GMFCS I, II or III: with the ability to walk independently with or without technical aids; with the ability to stand for 3 minutes independently or gripped on the stand; with the ability to understand and follow simple instructions; with the ability to tolerate clinical tests and examinations.

Exclusion Criteria

• Participation in treatments with serial casting or botulinum toxin during the 3 months prior to the study.
• Recent orthopedic surgery (less than 12 months).
• Participation in other muscle strengthening programs during the 4 months prior to this clinical study.
• Children who have developed fixed contractures in lower limbs joints.
• Medical conditions where physical exercise is contraindicated.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

MARIA JOSE DIAZ ARRIBAS

Tenured Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María J Díaz Arribas, PhD

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Ángela C Álvarez Melcón, PhD

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

María José Díaz Arribas

Madrid, , Spain

Countries

Spain

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Peungsuwan P, Parasin P, Siritaratiwat W, Prasertnu J, Yamauchi J. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study. Pediatr Phys Ther. 2017 Jan;29(1):39-46. doi: 10.1097/PEP.0000000000000338.

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Other Identifiers

20/551-EC

Identifier Type: -

Identifier Source: org_study_id