- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06077136
Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy (WBV)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hisham M Hussein, Dr
- Phone Number: +966543704108
- Email: hm.hussein@uoh.edu.sa
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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:
Other Names:
|
Experimental: 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:
|
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:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth scale (MAS) for muscle tone
Time Frame: at baseline
|
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
Time Frame: 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.
|
after the end of the treatment (after 4 weeks)
|
APILHAND-Kids scale for fine motor skills
Time Frame: baseline
|
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
Time Frame: 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/ .
|
after the end of the treatment (after 4 weeks)
|
eye-hand coordination using Mayro Device
Time Frame: at baseline
|
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
Time Frame: 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
|
after the end of the treatment (after 4 weeks)
|
handgrip strength using Myro device
Time Frame: at baseline
|
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
Time Frame: 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.
|
after the end of the treatment (after 4 weeks)
|
The quality of life using paediatric Cerebral Palsy Quality of Life (CP QoL) questionnaire
Time Frame: at baseline
|
It is 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
Time Frame: after the end of the treatment (after 4 weeks)
|
It is 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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2023-380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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