Effectiveness of Whole-Body Vibration (WBVibration)

Universidad Complutense de Madrid

Status: Completed

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

Treatments: Other: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06330311

20/551-EC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Whole-Body Vibration Group

Experimental group

Description:

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.

Treatment:

Other: Physiotherapy

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Physiotherapy