Clinical trial NCT06077136: Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy
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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Modified Ashworth scale (MAS) for muscle tone
timeFrame: at baseline
measure: Modified Ashworth scale (MAS) for muscle tone
timeFrame: after the end of the treatment (after 4 weeks)
measure: APILHAND-Kids scale for fine motor skills
timeFrame: baseline
measure: APILHAND-Kids scale for fine motor skills
timeFrame: after the end of the treatment (after 4 weeks)
measure: eye-hand coordination using Mayro Device
timeFrame: at baseline
measure: eye-hand coordination using Mayro Device
timeFrame: after the end of the treatment (after 4 weeks)
measure: handgrip strength using Myro device
timeFrame: at baseline
measure: handgrip strength using Myro device
timeFrame: after the end of the treatment (after 4 weeks)
measure: The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
timeFrame: at baseline
measure: The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
timeFrame: after the end of the treatment (after 4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Hisham Hussein
Study officials:
References: