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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- eye-hand coordination using Mayro Device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
eye-hand coordination using Mayro Device
时间窗: after the end of the treatment (after 4 weeks)
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
Modified Ashworth scale (MAS) for muscle tone
时间窗: after the end of the treatment (after 4 weeks)
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
时间窗: after the end of the treatment (after 4 weeks)
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/ .
handgrip strength using Myro device
时间窗: after the end of the treatment (after 4 weeks)
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
时间窗: after the end of the treatment (after 4 weeks)
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
次要结局
未报告次要终点
研究者
Hisham Mohamed Hussein
assistant professor
University of Hail