Mechanical Vibration on Children With Cerebral Palsy

NCT ID: NCT05593406

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2023-01-30

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.

Conditions

Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Vibration Group

The intervention-vibration group, in addition to the conventional physical therapy- NDT they received, were also included in mechanical vibration.

Group Type: EXPERIMENTAL

Vibration Group

Intervention Type: DEVICE

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

Control Group

The Control group received only conventional physical therapy- NDT.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

NDT treatment 2 sessions per week

Interventions

Vibration Group

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

Intervention Type: DEVICE

Control Group

NDT treatment 2 sessions per week

Intervention Type: OTHER

Other Intervention Names

Mechanical Vibration; Neurodevelopmental treatment; Neurodevelopmental Treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Besios

UNKNOWN

Sponsor Role: collaborator

Georgios Paras

UNKNOWN

Sponsor Role: collaborator

Konstantinos Chandolias

UNKNOWN

Sponsor Role: collaborator

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Aourela Gkioni

Msc Cand Aourela Gkioni

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Thessaly

Lamia, , Greece

Countries

Greece

References

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

Reference Type: BACKGROUND

Other Identifiers

AG12071996

Identifier Type: -

Identifier Source: org_study_id