Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403663291917 Date of Approval: 12/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Whole-body vibration versus functional strength training in hemiparetic children
Official scientific title Effect of whole-body vibration versus functional strength training on functional balance and aerobic capacity in children with hemiparetic cerebral palsy: A randomized clinical trial
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is a neurodevelopmental disorder that manifests during infancy or early childhood due to brain injury or developmental abnormalities. Cerebral palsy represents the most common motor disability in childhood. One of the common subtypes of cerebral palsy is hemiparesis. Children with hemiparetic CP experience various challenges such as impaired balance and reduced aerobic capacity, resulting in limited motor skills. This study aims to investigate the effect of whole-body vibration versus functional strength training on functional balance and aerobic capacity in children with hemiparetic CP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 27/02/2024
Actual trial start date 14/03/2024
Anticipated date of last follow up 21/05/2024
Actual Last follow-up date 06/06/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Whole body vibration 25 minutes of vibration and 5 minutes of rest intervals. three times a week for 12 weeks. To concentrate the vibration's energy on the lower extremities, the youngster stands on the WBV platform in a semi-squat posture (30 degrees of knee flexion). With a frequency of 20–30 Hz and a vertical displacement of 2-4 mm, the WBV application protocol consists of 25 minutes of vibration and 5 minutes of rest intervals. The objective of the WBV device is to increase the vibration frequency from 28 to 30 Hz and the peak-to-peak displacement to 2 mm (as determined for the middle toe of each foot) by increasing 0.8 or 1 Hz every three treatment sessions until the target frequency of 30 Hz is reached. 15
Control Group Functional strength training A 30-minute session, consisting of one to three sets of 10 to 15 repetitions for each exercise. three times a week for 12 weeks. Weights, higher steps, a lower bench, a slower pace, lessening the child's support, and/or performing more customized sets one-on-one are examples of progression; however, these options are typically modified after two weeks. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with hemiparetic cerebral palsy The Modified Ashworth Scale Spasticity Grade I and II Level I or II on the Gross Motor Functional Classification System (GMFCS) Able to understand simple verbal instructions and follow orders Parents/guardian's consent Fixed contractures and deformities Surgery within the preceding year BOTOX injections into the calf muscle during the previous year History of epileptic seizures Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 8 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/02/2023 Institutional Report Board at Kafrelshikh university
Ethics Committee Address
Street address City Postal code Country
Qism Kafr El-Shaikh, Kafr Al Sheikh First, Kafr El-Sheikh Governorate Kafrelshikh 33516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional balance Baseline and after 12 weeks
Secondary Outcome Aerobic capacity Baseline and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinics of The Faculty of Physical Therapy at Kafrelshikh university Qism Kafr El-Shaikh, Kafr Al Sheikh First, Kafr El-Sheikh Governorate Kafrelshikh 33516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
NA NA Kafrelshikh Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Shaqra University Al Duwadimi Road Shaqra 15526 Saudi Arabia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sara Elsebahy sarah_elsehy2014@pt.kfs.edu.eg +201094998882 Qism Kafr El-Shaikh, Kafr Al Sheikh First, Kafr El-Sheikh Governorate
City Postal code Country Position/Affiliation
Kafrelshikh 33516 Egypt 33516
Role Name Email Phone Street address
Scientific Enquiries aaa aaa aaaaaaa@gmail.com 00201234567890 aaa
City Postal code Country Position/Affiliation
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Role Name Email Phone Street address
Public Enquiries aaa aaa aaaaaaa@gmail.com 00201234567890 aaa
City Postal code Country Position/Affiliation
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REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Individual participant data that underline the results reported in this article will be shared after deidentification (text, tables, figures, and appendices). Clinical Study Report 1 year after registration available on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information