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Completed

NCT Number: NCT06330311

Effectiveness of Whole-Body Vibration

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Lower Extremity Weakness, Spastic Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paraparesis Paraparesis, Spastic Paresis Pathological Conditions, Signs and Symptoms Physical Therapy Modalities Signs and Symptoms Vibration; Exposure

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María José Díaz Arribas

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Physiotherapy

Other

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

Other names: Therapeutic exercise

Primary outcomes

  1. GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)

    Time frame: Baseline

    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. GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)

    Time frame: 1 month

    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.

  3. GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)

    Time frame: 2 months

    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.

  4. GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions)

    Time frame: 6 months

    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.

  5. Modified Ashworth Scale (MAS)

    Time frame: Baseline

    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. Modified Ashworth Scale (MAS)

    Time frame: 1 month

    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

  7. Modified Ashworth Scale (MAS)

    Time frame: 2 month

    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

  8. Modified Ashworth Scale (MAS)

    Time frame: 6 month

    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

Secondary outcomes

  1. 6 Minute Walking Test (6MWT)

    Time frame: Baseline

    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. 6 Minute Walking Test (6MWT)

    Time frame: 1 month

    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.

  3. 6 Minute Walking Test (6MWT)

    Time frame: 2 month

    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.

  4. 6 Minute Walking Test (6MWT)

    Time frame: 6 month

    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.

  5. Dynamometry

    Time frame: Baseline

    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. Dynamometry

    Time frame: 1 month

    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

  7. Dynamometry

    Time frame: 2 month

    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

  8. Dynamometry

    Time frame: 6 month

    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

  9. Mini-Balance Evaluation System Test

    Time frame: Baseline

    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.

  10. Mini-Balance Evaluation System Test

    Time frame: 1 month

    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.

  11. Mini-Balance Evaluation System Test

    Time frame: 2 month

    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.

  12. Mini-Balance Evaluation System Test

    Time frame: 6 month

    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.

  13. Cerebral Palsy Quality of Life questionnaire (CP-QOL)

    Time frame: Baseline

    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.

  14. Cerebral Palsy Quality of Life questionnaire (CP-QOL)

    Time frame: 2 month

    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.

  15. Cerebral Palsy Quality of Life questionnaire (CP-QOL)

    Time frame: 6 month

    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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Registry information

Official study title

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

Acronym: WBVibration

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
Apr 4, 2025

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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