Mechanical Vibration on Children With Cerebral Palsy

• Sponsor: University of Thessaly (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05593406
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of mechanical vibration on spasticity and balance in children with cerebral palsy. The participants of the clinical study will be 10 children with CP and age 4-16 years, with a diagnosis of cerebral palsy. More specifically, the participants will be 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 will also receive mechanical vibration using a hybervibe vibration platform, lasting 10 minutes. The intervention will last 8 weeks and participants will be assessed before the start of (T1), 1 month after the first assessment (T2) and rechecked 1 month (T3) after the completion of the program using valid and reliable tools.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy	Device: Vibration Group; Other: Control Group	N/A

Detailed Description

This is a randomized clinical study and 10 children, aged 5-16 (indicative) with diagnosed cerebral palsy will participate in the research. The collection of the sample and the recording of the data will be done in Pediatric Physiotherapy Private Practice centers in Lamia, Trikala and Katerini. Sampling will be done after written consent of the children's parents, as long as they have been 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 will last 8 weeks. The children who will participate in the study will be randomly divided through folders into an intervention group and a control group. The control group will continue the physical therapy program they are already following, while the intervention group, in addition to the conventional physical therapy they receive, will also resceive mechanical vibration. The program they are already following is 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 will be carried out in parallel with the conventional physical therapy program they follow. The protocol with the appropriate exercises to be followed on the HyperVibe G10 mini vibration platform will have a duration of 10 minutes, with a 3 minute break, the frequency of the mechanical vibration will be 18Hz, the opening of the legs (amplitude) on the platform and the range of bending the knees will depend on each participant and how safe they feel during the procedure. In front of them will be the possibility of supporting the upper limbs, for a possible loss of balance or if they feel insecure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The children who will participate in the study will be randomly divided through folders into an intervention group and a control group. The control group will continue the physical therapy program they are already following, while the intervention group, in addition to the conventional physical therapy they receive, will also receive mechanical vibration.The children who will participate in the study will be randomly divided through folders into an intervention group and a control group. The control group will continue the physical therapy program they are already following, while the intervention group, in addition to the conventional physical therapy they receive, will also receive mechanical vibration.
• Masking: Single (Participant)
• Masking Description: Randomly divided through folders
• Primary Purpose: Device Feasibility
• Official Title: The Effect of Mechanical Vibration on Spasticity and Balance in Children With Cerebral Palsy
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vibration Group The intervention-vibration group, in addition to the conventional physical therapy- NDT they receive, will also be included in mechanical vibration.	Device: Vibration Group; Whole body vibration for 10 minutes in squat position; Other Names: Mechanical Vibration Neurodevelopmental treatment
Active Comparator: Control Group The Control group wil receive only conventional physical therapy- NDT.	Other: Control Group; NDT treatment 2 sessions per week; Other Names: Neurodevelopmental Treatment

Outcome Measures

Primary Outcome Measures

1. TUG [2 months]

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

2. PBS [2 months]

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

3. MAS [2 months]

   Modified Asworth scale (spasticity)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The children from 5 - 16 years old (indicative)

• diagnosis of 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Thessaly	Lamía		Greece	35100

Sponsors and Collaborators

• University of Thessaly

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 1. Ahlborg, L., Andersson, C., & Julin, P. (2006). Whole-body vibration training compared with resistance training: Effect on spasticity, muscle strength and motor performance in adults with cerebral palsy. Journal of Rehabilitation Medicine, 38(5). https://doi.org/10.1080/16501970600680262 2. Ahmadizadeh, Z., Khalili, M. A., Ghalam, M. S., & Mokhlesin, M. (2019). Effect of whole body vibration with stretching exercise on active and passive range of motion in lower extremities in children with cerebral palsy: A randomized clinical trial. Iranian Journal of Pediatrics, 29(5). https://doi.org/10.5812/ijp.84436 3. Alashram, A. R., Padua, E., & Annino, G. (2019). Effects of Whole-Body Vibration on Motor Impairments in Patients With Neurological Disorders. In American Journal of Physical Medicine and Rehabilitation (Vol. 98, Issue 12). https://doi.org/10.1097/PHM.0000000000001252 4. Ali, M. S., Awad, A. S., & Elassal, M. I. (2019). The effect of two therapeutic interventions on balance in children with spastic cerebral palsy: A comparative study. Journal of Taibah University Medical Sciences, 14(4). https://doi.org/10.1016/j.jtumed.2019.05.005 5. Andrew Harb and Stephen Kishner. (2022). Modified Ashworth Scale. StatPearls. 6. Bax, M., Goldstein, M., Rosenbaum, P., Leviton, A., Paneth, N., & Dan, B. et al. (2005). Proposed definition and classification of cerebral palsy, April 2005. Developmental Medicine & Child Neurology, 47(8), 571-576. doi: 10.1017/s001216220500112x 7. Cans, C., Dolk, H., Platt, M. J., Colver, A., Prasauskiene, A., & Krägel-Oh-Mann, I. (2007). Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Developmental Medicine and Child Neurology, 49(SUPPL. 2). https://doi.org/10.1111/j.1469-8749.2007.tb12626.x 8. Cheng, H. Y. K., Ju, Y. Y., Chen, C. L., Chuang, L. L., & Cheng, C. H. (2015). Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Human Movement Science, 39. https://doi.org/10.1016/j.humov.2014.11.003 9. Christopher, A., Kraft, E., Olenick, H., Kiesling, R., & Doty, A. (2021). The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review: Psychometric properties of the Timed Up and Go. In Disability and Rehabilitation (Vol. 43, Issue 13). https://doi.org/10.1080/09638288.2019.1682066 10. El-Shamy, S. M. (2014). Effect of whole-body vibration on muscle strength and balance in diplegic cerebral palsy: A randomized controlled trial. American Journal of Physical Medicine and Rehabilitation, 93(2). https://doi.org/10.1097/PHM.0b013e3182a541a4 11. Franjoine, M., Darr, N., Held, S., Kott, K., & Young, B. (2010). The Performance of Children Developing Typically on the Pediatric Balance Scale. Pediatric Physical Therapy, 22(4), 350-359. https://doi.org/10.1097/pep.0b013e3181f9d5eb 12. Fratini, A., Bonci, T., & Bull, A. M. J. (2016). Whole body vibration treatments in postmenopausal women can improve bone mineral density: Results of a stimulus focussed meta-analysis. PLoS ONE, 11(12). https://doi.org/10.1371/journal.pone.0166774

• Responsible Party: Aourela Gkioni, Msc Cand Aourela Gkioni, University of Thessaly
• ClinicalTrials.gov Identifier: NCT05593406
• Other Study ID Numbers: AG12071996
• First Posted: Oct 25, 2022
• Last Update Posted: Oct 25, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aourela Gkioni, Msc Cand Aourela Gkioni, University of Thessaly: Cerebral palsy; Balance; Neurodevelopmental treatment; Whole body vibration; Spasticity
• Additional relevant MeSH terms: Paralysis; Cerebral Palsy

Study Results

No Results Posted as of Oct 25, 2022