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Completed

NCT Number: NCT05593406

Mechanical Vibration on Children With Cerebral Palsy

The purpose of this study was to assess the effect of mechanical vibration on spasticity and balance in children with cerebral palsy. The participants of the clinical study are 13 children with CP and age 4-17 years, with a diagnosis of spastic hemiplegic cerebral palsy. More specifically, the participants were randomly divided into a control group and an intervention group, with the first group continuing conventional physical therapy, while the experimental group outside the physical therapy program did also receive mechanical vibration using a hybervibe G10 vibration platform (lasting 15 minutes). The intervention lasted 8 weeks and participants were assessed before the start of the intervention (T1), 1 month after the first assessment (T2) and rechecked 1 month (T3) after the completion of the program using valid and reliable tools.

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Key information

About this study

This is a randomized clinical study and 13 children, aged 4-17 with diagnosed spastic hemiplegic cerebral palsy participated in the research. The collection of the sample and the recording of the data took place in Pediatric Physiotherapy Private Practice centers in Lamia, Trikala and Katerini. Sampling was completed after written consent of the children's parents, as long as they were fully informed about the purposes of the research, the private physical therapy centers and the Human Performance & Rehabilitation Laboratory of the University of Thessaly.

The time period that the clinical study intervention lasted was 8 weeks. The children who participated in the study were randomly divided through folders into an intervention group and a control group. The control group continued the physical therapy program they were already following, while the intervention group, in addition to the conventional physical therapy they received, did also resceive mechanical vibration. The program they were already following was based on the Bobath NDT Neuroevolutionary Method, where, through special manipulations, the emphasis is placed on improving the quality of movement and the functionality of the children, as well as the inclusion of the family in the wider treatment is considered important.

The inclusion of mechanical vibration in the children was carried out in parallel with the conventional physical therapy program they followed. The protocol with the appropriate exercises to be followed on the HyperVibe G10 mini vibration platform had a duration of 15 minutes, with a 2 minute break, the frequency of the mechanical vibration was 14Hz, the opening of the legs (amplitude) on the platform and the range of bending the knees depended on each participant and how safe they felt during the procedure. In front of them there was the possibility of supporting the upper limbs, for a possible loss of balance or if they felt insecure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The children from 4 - 17 years old
  • diagnosis of spastic hemiplegic cerebral palsy
  • ability to understand simple commands.
  • up to level GMFCS III,
  • able to stand and walk (with or without mobility aids).

Exclusion criteria

  • children who have been injected with botulinum toxin up to 3 months before
  • children who have undergone selective rhizotomy surgery up to 1 year before,
  • uncontrolled epilepsy,
  • other pathologies that will affect the outcome of the intervention.

Treatment and study plan

Vibration Group

Device

Whole body vibration for 15 minutes in squat and lunge position.

Other names: Mechanical Vibration, Neurodevelopmental treatment

Control Group

Other

NDT treatment 2 sessions per week

Other names: Neurodevelopmental Treatment

Primary outcomes

  1. TUG

    Time frame: 2 months

    TIMED UP AND GO (Scale to asses speed) (the minimum time the better)

  2. PBS

    Time frame: 2 months

    PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)

  3. MAS

    Time frame: 2 months

    Modified Asworth scale (spasticity)

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • Georgios Paras
  • Konstantinos Chandolias
  • Thomas Besios

Registry information

Official study title

The Effect of Mechanical Vibration on Spasticity and Balance in Children With Cerebral Palsy

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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