Mechanical Vibration on Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy
• Interventions: Device: Vibration Group; Other: Control Group

• Registration Number: NCT05593406
• Lead Sponsor: University of Thessaly

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Study Start: 2022-10-30
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration Group	Vibration Group	The intervention-vibration group, in addition to the conventional physical therapy- NDT they received, were also included in mechanical vibration.
Control Group	Control Group	The Control group received only conventional physical therapy- NDT.

Primary Outcome Measures

Name	Time	Method
MAS	2 months	Modified Asworth scale (spasticity)
TUG	2 months	TIMED UP AND GO (Scale to asses speed) (the minimum time the better)
PBS	2 months	PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)

Trial Locations

Locations (1)

University of Thessaly; 🇬🇷 Lamía, Greece