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.: PACTR201911464670144 Date of Approval: 12/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of whole body vibration on spasticity in children with cerebral palsy
Official scientific title Effect of whole body vibration on spasticity in children with cerebral palsy
Brief summary describing the background and objectives of the trial One of the many problems that spastic cerebral palsy children suffer from is spasticity which is characterized by hyperrflexia of the muscle, especially the soleus muscle, which affects the functional abilities and standing of the child. In this study we were detecting the effect of whole body vibration on spasticity in children with spastic cerebral palsy. The effect of treatment maneuver was assessed by H/M ratio immediatly , after 30 minutes and after 1 hour of the whole body vibration application. Thirty children with spasticity enrolled in this study (fifteen hemiplegic and fifteen diplegic ).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 28/01/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 01/06/2019
Actual Last follow-up date 01/06/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group whole body vibration the whole body vibration was applied using 20 HZ frequency for 20 minutes for each patient 20 minutes the whole body vibration was applied using 20 HZ frequency for 20 minutes for each patient while standing with knees partially bent 30
Control Group regular physical therapy program selected exercise program three times per week one hour stretching exercise , balance training and vestibular training 0 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. age 4 to 6 years spasticity grade 1 and 1 + on modified ashwarth scale level 1 and 2 of the gross motor function classification system children are able to understand and follow orders visual or auditory problems epilepsy fixed contractures and deformities children with surgical intervention less than one year Preschool Child: 2 Year-5 Year 4 Year(s) 6 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 11/02/2018 ethics committee faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzaiat street cairo 12631 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome degree of spasticity immediately , after 30 minutes , after 1 hour
Secondary Outcome popliteal angle immediately , after 30 minutes , after 1 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic faculty of physical therapy 7 ahmed el zaiat street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ayah reda abdallah abouserie elsharawy street -atreeb - benha - qulubia - egypt benha Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7 ahmed elzaiat street cairo Egypt University
Secondary Sponsor faculty of physical therapy 7 ahmed elzaiat street cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
abd elhamid salah elhamshary faculty of medicine benha university - benha - qulubia - egypt benha Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ayah abouserie white.oleander9090@gmail.com +201008622710 elsharawy street , atreeb , benha .qulubia
City Postal code Country Position/Affiliation
benha Egypt physiotherapist at benha hospital
Role Name Email Phone Street address
Public Enquiries mohamed elshafay elrahmapt@gmail.com +20120128023088 7 ahmed elzaiat
City Postal code Country Position/Affiliation
cairo Egypt assisstant professor at pediatric department faculty of physical therapy
Role Name Email Phone Street address
Scientific Enquiries doaa sanad dr.doaa.sanad@gmail.com +201007206392 143A hadaek elahram
City Postal code Country Position/Affiliation
cairo Egypt lecturer at pediatric physical therapy department faculty of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes measures of spasticity Statistical Analysis Plan 1 december till 30 december controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes This study was applied to detect the effect of whole body vibration device on spasticity in spastic cerebral palsy children which proved to have a significant diference comparing the pre-application results with the three post application results (immediately after and after 30 minutes and after 1 hour ) which means that its effect lasts up to 1 hour from the application 07/11/2019 01/12/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks P.T.REC/012/001846
Changes to trial information