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Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy (WBV)

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
whole body vibration
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age between 5 and 14 years, who had a diagnosed with spastic cerebral palsy by a pediatrician, 1-3 on Ashworth Scale (MAS) for upper limb muscles whose parents/guardians sign the informed consent, who were willing to complete the study. Exclusion Criteria: Children with anatomical disorder or deformity in the upper limb, Children who received a botulinum toxin injection in the upper limb muscles during the last six months Surgery in the lower extremity during the previous year Severe associated neurological diseases as epilepsy Poor nutritional status. Those who do not agree to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    regular physical therapy group

    whole body vibration

    Arm Description

    this group will receive regular physical therapy 3 -5 times per week. this program will be designed according to the needs of each child. strength, stretch, facilitation, splinting, coordination, and functional exercises are examples of the components of the programs.

    in addition to the regular exercises, selected arm exercises will be performed while the child is under whole-body vibration. using (Galileo® MED 25 TT, Germany; 2021 model) with the following parameters: WBV session duration: 10 minutes (rest periods can be incorporated frequency: 12 Hz Amplitude: 2 (fixed) duration of each exercise: 2-3 minutes

    Outcomes

    Primary Outcome Measures

    Modified Ashworth scale (MAS) for muscle tone
    For clinical assessment of spasticity, the Modified Ashworth scale (MAS) will be used to assess the level of calf muscle spasticity. The assessor will apply passive ankle dorsiflexion on the affected side and determine the appropriate grade of spasticity. MAS grades range from 0, for normal muscle tone to 4 for extreme spasticity.
    Modified Ashworth scale (MAS) for muscle tone
    For clinical assessment of spasticity, the Modified Ashworth scale (MAS) will be used to assess the level of calf muscle spasticity. The assessor will apply passive ankle dorsiflexion on the affected side and determine the appropriate grade of spasticity. MAS grades range from 0, for normal muscle tone to 4 for extreme spasticity.
    APILHAND-Kids scale for fine motor skills
    ABILHAND-Kids is a parent-reported questionnaire measuring manual ability in children with cerebral palsy (CP). It includes 21 specific items. The Parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity by choosing "Impossible", "Difficult" or "Easy". The final score will be obtained using software available on http://rssandbox.iescagilly.be/ .
    APILHAND-Kids scale for fine motor skills
    ABILHAND-Kids is a parent-reported questionnaire measuring manual ability in children with cerebral palsy (CP). It includes 21 specific items. The Parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity by choosing "Impossible", "Difficult" or "Easy". The final score will be obtained using software available on http://rssandbox.iescagilly.be/ .
    eye-hand coordination using Mayro Device
    using Mayro Device, Tyromotion, a device with a large touch screen that allows many training and assessment options. On the screen, multiple marks are arranged to form a circle with one mark located in the center. The child will be asked to trace these marks to make a final figure of a star. Errors will be calculated, and the final results will reflect the score of the child where higher score s means better achievement
    eye-hand coordination using Mayro Device
    using Mayro Device, Tyromotion, a device with a large touch screen that allows many training and assessment options. On the screen, multiple marks are arranged to form a circle with one mark located in the center. The child will be asked to trace these marks to make a final figure of a star. Errors will be calculated, and the final results will reflect the score of the child where higher score s means better achievement
    handgrip strength using Myro device
    Using the ball (a specific accessory of the Mayro device) , the child will be asked to hold and squeeze the ball as hard as possible while the ball is attached to the Mayro device. The sensors within the ball will determine the pressure exerted by the child and the score will be recorded.
    handgrip strength using Myro device
    Using the ball (a specific accessory of the Mayro device) , the child will be asked to hold and squeeze the ball as hard as possible while the ball is attached to the Mayro device. The sensors within the ball will determine the pressure exerted by the child and the score will be recorded.
    The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
    It is covers the age ranges of 4-12 (i.e., CP QoL-Child). and 13-18 (i.e., CP QoL-Teen). Both CP QoL-Child and CP QoL-Teen were reported to be validated tools with strong psychometric properties and clinical utility. The translated Arabic version of CP-QOL questionnaire (caregiver form) is valid and reliable. the higher scores mean better QoL
    The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
    It is covers the age ranges of 4-12 (i.e., CP QoL-Child). and 13-18 (i.e., CP QoL-Teen). Both CP QoL-Child and CP QoL-Teen were reported to be validated tools with strong psychometric properties and clinical utility. The translated Arabic version of CP-QOL questionnaire (caregiver form) is valid and reliable. the higher scores mean better QoL

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 4, 2023
    Sponsor
    University of Hail
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077136
    Brief Title
    Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy
    Acronym
    WBV
    Official Title
    Efficacy of Upper Limb Exercises Using Whole Body Vibration on Muscle Tone, Motor Skills, Handgrip Strength, and Quality of Life in Children With Spastic Upper Motor Neuron Lesion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    February 15, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Hail

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Spasticity is one of the most common features in children with cerebral palsy (CP) and is evident in the majority of CP types such as hemiplegia, diplegia, quadriplegia, etc. Children with spastic upper motor neuron lesions often experience difficulties with muscle tone and movement, impacting their functional abilities and quality of life. Conventional treatments such as physical therapy and medication have demonstrated positive effects in the management of spasticity. However, alternative interventions like whole body vibration (WBV) have gained attention due to their potential to modulate muscle tone and improve functional outcomes. WBV involves the transmission of mechanical vibrations to the whole body or specific body parts. These vibrations stimulate sensory receptors and elicit muscular responses, potentially leading to improved muscle tone regulation and reduced spasticity.
    Detailed Description
    Several studies have investigated the effects of WBV on spasticity management. These studies have reported various outcomes, providing valuable insights into the potential benefits of this intervention. Previous studies showed an immediate reduction of spasticity of the calf muscle, increased the range of the popliteal angle, and improved step length, step width, foot angle, and walking speed. The current study seeks to address some of the limitations observed in previous research. It employs a randomized controlled trial design with a predetermined sample size, enhancing the statistical power and generalizability of the findings. The intervention group will receive supervised upper limb exercises using WBV, while the control group will receive conventional therapy. By comparing these two groups, the study aims to provide more robust evidence regarding the specific effects of WBV on muscle tone and spasticity. Furthermore, the current study will utilize standardized assessment tools to measure muscle tone, spasticity, and functional outcomes pre-and post-intervention. This will allow for a comprehensive evaluation of the effects of WBV on spasticity management, encompassing both objective measures and functional improvements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    the model of this study will be 2 parallel arms where one arm will receive regular physical therapy including exercises to the upper limb and the experimental group will receive the same physical therapy plus upper limb exercises applied using the whole body vibration device
    Masking
    Outcomes Assessor
    Masking Description
    Concealed allocation will be performed by a researcher who will not be involved in the treatment or assessment. Permuted blocks will be used to ensure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the data analyzer will be blinded
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    regular physical therapy group
    Arm Type
    Active Comparator
    Arm Description
    this group will receive regular physical therapy 3 -5 times per week. this program will be designed according to the needs of each child. strength, stretch, facilitation, splinting, coordination, and functional exercises are examples of the components of the programs.
    Arm Title
    whole body vibration
    Arm Type
    Experimental
    Arm Description
    in addition to the regular exercises, selected arm exercises will be performed while the child is under whole-body vibration. using (Galileo® MED 25 TT, Germany; 2021 model) with the following parameters: WBV session duration: 10 minutes (rest periods can be incorporated frequency: 12 Hz Amplitude: 2 (fixed) duration of each exercise: 2-3 minutes
    Intervention Type
    Other
    Intervention Name(s)
    whole body vibration
    Other Intervention Name(s)
    WBV
    Intervention Description
    3 sessions per week consisted of different types of exercises, all of which were performed while the child will be is under WBV using (Galileo® MED 25 TT, Germany; 2021 model) with the following parameters: WBV session duration: 10 minutes (rest periods can be incorporated (1-2 minutes maximum 3 times during the session) frequency: 12 Hz Amplitude: 2 (fixed) duration of each exercise: 2-3 minutes starting positions differ according to each exercise; upper limb weight-bearing and weight shift (from prone, prone on elbows, sitting, standing). upper limb active exercises using toys/ balls / wand. Involving throwing, catching, transfer between both hands (according to the abilities of each child). coordination exercises by asking the child to approximate the index finger of both hands together, perform finger-to-nose (eyes open and closed), and finger-to-therapist finger exercises.
    Primary Outcome Measure Information:
    Title
    Modified Ashworth scale (MAS) for muscle tone
    Description
    For clinical assessment of spasticity, the Modified Ashworth scale (MAS) will be used to assess the level of calf muscle spasticity. The assessor will apply passive ankle dorsiflexion on the affected side and determine the appropriate grade of spasticity. MAS grades range from 0, for normal muscle tone to 4 for extreme spasticity.
    Time Frame
    at baseline
    Title
    Modified Ashworth scale (MAS) for muscle tone
    Description
    For clinical assessment of spasticity, the Modified Ashworth scale (MAS) will be used to assess the level of calf muscle spasticity. The assessor will apply passive ankle dorsiflexion on the affected side and determine the appropriate grade of spasticity. MAS grades range from 0, for normal muscle tone to 4 for extreme spasticity.
    Time Frame
    after the end of the treatment (after 4 weeks)
    Title
    APILHAND-Kids scale for fine motor skills
    Description
    ABILHAND-Kids is a parent-reported questionnaire measuring manual ability in children with cerebral palsy (CP). It includes 21 specific items. The Parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity by choosing "Impossible", "Difficult" or "Easy". The final score will be obtained using software available on http://rssandbox.iescagilly.be/ .
    Time Frame
    baseline
    Title
    APILHAND-Kids scale for fine motor skills
    Description
    ABILHAND-Kids is a parent-reported questionnaire measuring manual ability in children with cerebral palsy (CP). It includes 21 specific items. The Parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity by choosing "Impossible", "Difficult" or "Easy". The final score will be obtained using software available on http://rssandbox.iescagilly.be/ .
    Time Frame
    after the end of the treatment (after 4 weeks)
    Title
    eye-hand coordination using Mayro Device
    Description
    using Mayro Device, Tyromotion, a device with a large touch screen that allows many training and assessment options. On the screen, multiple marks are arranged to form a circle with one mark located in the center. The child will be asked to trace these marks to make a final figure of a star. Errors will be calculated, and the final results will reflect the score of the child where higher score s means better achievement
    Time Frame
    at baseline
    Title
    eye-hand coordination using Mayro Device
    Description
    using Mayro Device, Tyromotion, a device with a large touch screen that allows many training and assessment options. On the screen, multiple marks are arranged to form a circle with one mark located in the center. The child will be asked to trace these marks to make a final figure of a star. Errors will be calculated, and the final results will reflect the score of the child where higher score s means better achievement
    Time Frame
    after the end of the treatment (after 4 weeks)
    Title
    handgrip strength using Myro device
    Description
    Using the ball (a specific accessory of the Mayro device) , the child will be asked to hold and squeeze the ball as hard as possible while the ball is attached to the Mayro device. The sensors within the ball will determine the pressure exerted by the child and the score will be recorded.
    Time Frame
    at baseline
    Title
    handgrip strength using Myro device
    Description
    Using the ball (a specific accessory of the Mayro device) , the child will be asked to hold and squeeze the ball as hard as possible while the ball is attached to the Mayro device. The sensors within the ball will determine the pressure exerted by the child and the score will be recorded.
    Time Frame
    after the end of the treatment (after 4 weeks)
    Title
    The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
    Description
    It is covers the age ranges of 4-12 (i.e., CP QoL-Child). and 13-18 (i.e., CP QoL-Teen). Both CP QoL-Child and CP QoL-Teen were reported to be validated tools with strong psychometric properties and clinical utility. The translated Arabic version of CP-QOL questionnaire (caregiver form) is valid and reliable. the higher scores mean better QoL
    Time Frame
    at baseline
    Title
    The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
    Description
    It is covers the age ranges of 4-12 (i.e., CP QoL-Child). and 13-18 (i.e., CP QoL-Teen). Both CP QoL-Child and CP QoL-Teen were reported to be validated tools with strong psychometric properties and clinical utility. The translated Arabic version of CP-QOL questionnaire (caregiver form) is valid and reliable. the higher scores mean better QoL
    Time Frame
    after the end of the treatment (after 4 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 5 and 14 years, who had a diagnosed with spastic cerebral palsy by a pediatrician, 1-3 on Ashworth Scale (MAS) for upper limb muscles whose parents/guardians sign the informed consent, who were willing to complete the study. Exclusion Criteria: Children with anatomical disorder or deformity in the upper limb, Children who received a botulinum toxin injection in the upper limb muscles during the last six months Surgery in the lower extremity during the previous year Severe associated neurological diseases as epilepsy Poor nutritional status. Those who do not agree to participate in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hisham M Hussein, Dr
    Phone
    +966543704108
    Email
    hm.hussein@uoh.edu.sa

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy

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