Mechanical Vibration on Children With Cerebral Palsy

NCT05593406 | Completed

• 1 other identifier: AG12071996
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy

Keywords

Cerebral palsy; Balance; Neurodevelopmental treatment; Whole body vibration; Spasticity

Outcome Measures

Primary Outcomes (3)

• TUG

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

  2 months

• PBS

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

  2 months

• MAS

  Modified Asworth scale (spasticity)

  2 months

Study Arms (2)

Vibration Group

EXPERIMENTAL

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

Device: Vibration Group

Control Group

ACTIVE COMPARATOR

The Control group received only conventional physical therapy- NDT.

Other: Control Group

Interventions

Vibration Group DEVICE

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

Also known as: Mechanical Vibration, Neurodevelopmental treatment

Vibration Group

Control Group OTHER

NDT treatment 2 sessions per week

Also known as: Neurodevelopmental Treatment

Control Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Thessaly: lead
• Thomas Besios: collaborator
• Georgios Paras: collaborator
• Konstantinos Chandolias: collaborator

Study Sites (1)

University of Thessaly

Lamia, 35100, Greece

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomly divided through folders
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Cand Aourela Gkioni

Model Details: 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 receive mechanical vibration.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: October 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)