Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy

NCT06077136 | Completed

• 1 other identifier: H-2023-380
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (10)

• 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.

  at baseline

• 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.

  after the end of the treatment (after 4 weeks)

• 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/ .

  baseline

• 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/ .

  after the end of the treatment (after 4 weeks)

• 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

  at baseline

• 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

  after the end of the treatment (after 4 weeks)

• 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.

  at baseline

• 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.

  after the end of the treatment (after 4 weeks)

• The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire

  Quality of life questionnaire 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

  at baseline

• The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire

  Quality of life questionnaire 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

  after the end of the treatment (after 4 weeks)

Study Arms (2)

regular physical therapy group

ACTIVE COMPARATOR

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.

Other: standard physical therapy

whole body vibration

EXPERIMENTAL

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

Other: whole body vibration; Other: standard physical therapy

Interventions

whole body vibration OTHER

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.

Also known as: WBV

whole body vibration

standard physical therapy OTHER

all children will receive regular exercises according to their developmental abilities such as stretching, strengthening, facilitation, or inhibition as well as functional exercises. exercise sessions will be 3 times per week fo

Also known as: exercises

regular physical therapy group; whole body vibration

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 5 and 14 years,
• who had a diagnosed with spastic cerebral palsy by a pediatrician,
• on Ashworth Scale (MAS) for upper limb muscles
• whose parents/guardians sign the informed consent,
• who were willing to complete the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

Hisham Hussein

Hail, 3994, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 16, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)