CompletedNot Applicable

Whole Body Vibration in Rehabilitation of Spastic Cerebral Palsy

Saudi Arabia56 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range

5 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Ashworth scale (MAS) for muscle tone

Timeframe: at baseline

Modified Ashworth scale (MAS) for muscle tone

Timeframe: after the end of the treatment (after 4 weeks)

APILHAND-Kids scale for fine motor skills

Timeframe: baseline

APILHAND-Kids scale for fine motor skills

Timeframe: after the end of the treatment (after 4 weeks)

eye-hand coordination using Mayro Device

Timeframe: at baseline

eye-hand coordination using Mayro Device

Timeframe: after the end of the treatment (after 4 weeks)

handgrip strength using Myro device

Timeframe: at baseline

Trial details

NCT IDNCT06077136

SponsorUniversity of Hail

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

5 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Modified Ashworth scale (MAS) for muscle tone

Timeframe: at baseline

Modified Ashworth scale (MAS) for muscle tone

Timeframe: after the end of the treatment (after 4 weeks)

APILHAND-Kids scale for fine motor skills

Timeframe: baseline

APILHAND-Kids scale for fine motor skills

Timeframe: after the end of the treatment (after 4 weeks)

eye-hand coordination using Mayro Device

Timeframe: at baseline

eye-hand coordination using Mayro Device

Timeframe: after the end of the treatment (after 4 weeks)

handgrip strength using Myro device

Timeframe: at baseline