Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy

NCT ID: NCT06077136

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-07-16

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

regular physical therapy group

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.

Group Type: ACTIVE_COMPARATOR

standard physical therapy

Intervention Type: 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

whole body vibration

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

Group Type: EXPERIMENTAL

whole body vibration

Intervention Type: 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.

standard physical therapy

Intervention Type: 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

Interventions

whole body vibration

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.

Intervention Type: OTHER

standard physical therapy

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

Intervention Type: OTHER

Other Intervention Names

WBV; exercises

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohamed Hussein

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hisham Hussein

Hail, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2023-380

Identifier Type: -

Identifier Source: org_study_id