Effectiveness of Whole-Body Vibration (WBVibration)

Effectiveness of Whole-Body Vibration on Lower Limb Motor Function and Spasticity in Children With Spastic Cerebral Palsy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle Spasticity; Spastic Cerebral Palsy; Vibration; Exposure; Physical Therapy Modalities; Lower Extremity Weakness, Spastic
• Intervention / Treatment: Other: Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María J Díaz Arribas, PhD; Phone Number: +34 913941545; Email: mjdiazar@ucm.es
• Study Contact Backup: Name: Íñigo Monzón Tobalina, Master; Phone Number: +34 913941545; Email: imonzontobalina@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28040
    • María José Díaz Arribas
    • Contact: Ángela C Álvarez Melcón, Professor; Phone Number: 00343941545; Email: angela.alvarez@ucm.es
    • Principal Investigator: Íñigo Monzón Tobalina, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Physiotherapy; Evidence-based multimodal physiotherapy treatment based on learning and motor control; Other Names: Therapeutic exercise
Active Comparator: 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.	Other: Physiotherapy; Evidence-based multimodal physiotherapy treatment based on learning and motor control; Other Names: Therapeutic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension	Baseline
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension	1 month
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension	2 month
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone. MAS is a 6 point numerical scale that graded muscle tone from 0 to 4: 0 = No increase in muscle tone 1 = Slight increase in muscle tone. Minimal resistance at end of range of motion 1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion 2 = More marked increase in muscle tone through most range of motion. Affected part easily moved 3 = Considerable increase in muscle tone. Passive movement difficult 4 = Affected part rigid in flexion or extension	6 month
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.	Baseline
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.	1 month
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.	2 months
GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)	GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy. The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions: A: Lying and rolling. The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome. B: Sitting. The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome. C: Crawling and Kneeling. The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome. D: Standing. The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome. E: Walking, running and jumping. The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome. The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface. The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	Baseline
6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface. The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	1 month
6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface. The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	2 month
6 Minute Walking Test (6MWT)	6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface. The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.	6 month
Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	Baseline
Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	1 month
Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	2 month
Dynamometry	Hand dynamometer will be used to measure the strength in these muscles of the lower limbs: Ankle dorsal flexion; Ankle plantar flexion; Hip flexors; Hip extensors; Knee flexors; Knee extensors; Hip abductors	6 month
Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2. - Anticipatory The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Reactive Postural Control The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Sensory Orientation The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Dynamic Gait The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome. The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	Baseline
Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2. - Anticipatory The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Reactive Postural Control The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Sensory Orientation The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Dynamic Gait The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome. The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	1 month
Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2. - Anticipatory The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Reactive Postural Control The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Sensory Orientation The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Dynamic Gait The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome. The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	2 month
Mini-Balance Evaluation System Test	The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2. - Anticipatory The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Reactive Postural Control The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Sensory Orientation The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome. - Dynamic Gait The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome. The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.	6 month
Cerebral Palsy Quality of Life questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy. It sets up a profile of qualify of life of children with CP and understand their perception of life. There are two versions of the CP-QOL: - A primary caregiver-proxy report version. The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome. - A self-report version for children with CP The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.	Baseline
Cerebral Palsy Quality of Life questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy. It sets up a profile of qualify of life of children with CP and understand their perception of life. There are two versions of the CP-QOL: - A primary caregiver-proxy report version. The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome. - A self-report version for children with CP The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.	2 month
Cerebral Palsy Quality of Life questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy. It sets up a profile of qualify of life of children with CP and understand their perception of life. There are two versions of the CP-QOL: - A primary caregiver-proxy report version. The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome. - A self-report version for children with CP The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.	6 month

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
• Investigators: Study Director: María J Díaz Arribas, PhD, Universidad Complutense de Madrid; Study Director: Ángela C Álvarez Melcón, PhD, Universidad Complutense de Madrid

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2024
• Primary Completion (Estimated): September 29, 2024
• Study Completion (Estimated): September 29, 2024

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Physical Therapy; Spastic Cerebral Palsy; Whole-Body Vibration; Gross Motor Function; Lower Limb Spasticity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Paresis; Paraparesis; Cerebral Palsy; Muscle Spasticity; Paraparesis, Spastic
• Other Study ID Numbers: 20/551-EC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No