Mechanical Vibration on Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Vibration Group
Control Group
Sponsored by
About this trial
This is an interventional device feasibility trial for Cerebral Palsy focused on measuring Cerebral palsy, Balance, Neurodevelopmental treatment, Whole body vibration, Spasticity
Eligibility Criteria
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.
Sites / Locations
- University of Thessaly
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vibration Group
Control Group
Arm Description
The intervention-vibration group, in addition to the conventional physical therapy- NDT they received, were also included in mechanical vibration.
The Control group received only conventional physical therapy- NDT.
Outcomes
Primary Outcome Measures
TUG
TIMED UP AND GO (Scale to asses speed) (the minimum time the better)
PBS
PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)
MAS
Modified Asworth scale (spasticity)
Secondary Outcome Measures
Full Information
NCT ID
NCT05593406
First Posted
October 20, 2022
Last Updated
February 15, 2023
Sponsor
University of Thessaly
Collaborators
Thomas Besios, Georgios Paras, Konstantinos Chandolias
1. Study Identification
Unique Protocol Identification Number
NCT05593406
Brief Title
Mechanical Vibration on Children With Cerebral Palsy
Official Title
The Effect of Mechanical Vibration on Spasticity and Balance in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly
Collaborators
Thomas Besios, Georgios Paras, Konstantinos Chandolias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy
Keywords
Cerebral palsy, Balance, Neurodevelopmental treatment, Whole body vibration, Spasticity
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Randomly divided through folders
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibration Group
Arm Type
Experimental
Arm Description
The intervention-vibration group, in addition to the conventional physical therapy- NDT they received, were also included in mechanical vibration.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The Control group received only conventional physical therapy- NDT.
Intervention Type
Device
Intervention Name(s)
Vibration Group
Other Intervention Name(s)
Mechanical Vibration, Neurodevelopmental treatment
Intervention Description
Whole body vibration for 15 minutes in squat and lunge position.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Neurodevelopmental Treatment
Intervention Description
NDT treatment 2 sessions per week
Primary Outcome Measure Information:
Title
TUG
Description
TIMED UP AND GO (Scale to asses speed) (the minimum time the better)
Time Frame
2 months
Title
PBS
Description
PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)
Time Frame
2 months
Title
MAS
Description
Modified Asworth scale (spasticity)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Thessaly
City
Lamía
ZIP/Postal Code
35100
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
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Mechanical Vibration on Children With Cerebral Palsy
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