Clinical Trials Directory

Trials / Completed

CompletedNCT06077136

Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
University of Hail · Academic / Other
Sex
All
Age
5 Years – 14 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERwhole body vibration3 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.
OTHERstandard physical therapyall 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

Timeline

Start date
2023-12-01
Primary completion
2024-06-30
Completion
2024-07-16
First posted
2023-10-11
Last updated
2025-01-07

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT06077136. Inclusion in this directory is not an endorsement.