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.: PACTR202007625049282 Date of Approval: 28/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of repetitive Transcranial Magnetic Stimulation in spasticity modulation of Spastic Hemiplegic Children
Official scientific title Effect of repetitive Transcranial Magnetic Stimulation in decreasing muscle tone of Spastic Hemiplegic Children
Brief summary describing the background and objectives of the trial Spastic cerebral palsy (cp) is one of the most common neurological disorders occurring due to damage to immature brain or any other brain lesion at the time of birth. To aid in making the life of the CP patient meaningful, several interventions such as medical, surgical and rehabilitation have been employed to date. Besides these, recently repetitive transcranial magnetic stimulation ( r-TMS) is a newfound approach which is being employed for treating various neurological and psychological conditions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 27/07/2020
Actual trial start date 10/08/2020
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet 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 a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard treatment Stretching exercises, neurodevelopment technique (Bobath approach), strengthening exercises, balance and gait training exercises). This program was done in approximately one hour, three times per week for 4 successive weeks. 4 successive weeks. Stretching exercises, neurodevelopment technique (Bobath approach), strengthening exercises, balance and gait training exercises). This program was done in approximately one hour, three times per week for 4 successive weeks. 15 Active-Treatment of Control Group
Experimental Group Magnetic Stimulation Repetitive Transcranial Magnetic Stimulation frequency of 10 Hz was administered consisting of 1500 pulses for 15 min daily for 20 days to patients in SG followed by standard therapy of 1 h duration daily 4 weeks (5 days per week). 4 weeks Repetitive Transcranial Magnetic Stimulation frequency of 10 Hz was administered consisting of 1500 pulses for 15 min daily for 20 days to patients in SG followed by standard therapy of 1 h duration daily 4 weeks (5 days per week). 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
spastic hemiplegic CP children with ages ranged from 7 to 14 years old had grade 1 or 1+ according to modified Ashworth scale and grade II or III according to Manual Ability Classification Scale (MACS), they can understand and follow verbal commands and instructions included in the test, and they had no sensory impairment or other neurological or psychological problems other than mild perceptual defects. children with any other neurological deficits such as convulsions, involuntary movements or receiving muscle relaxants, children with impairment of sensation (superficial, deep and cortical), children with Any metallic implant such as a pacemaker or metallic foreign body, children with any other diseases such as cardiac disease and with severe mental retardation (IQ not less than 50), children with congenital disorders such as Down’s syndrome, fragile- X syndrome or any congenital anomalies. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 7 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 01/03/2020 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. bein srayyat giza ,Egypt Cairo 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome gait parameters (ankle joint angle at initial contact, stride length, cadence and speed) pre-test post-treatment
Secondary Outcome modified Ashworth scale for spasticity pre-test post- treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EDEN physical therapy center 6 October City Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Mostafa 77 shalhoub st. ain shams Cairo , Egypt Cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eden Healthcare 6 October city Giza 11411 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ahmed essmat ain shams
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Associate professor department of basic science faculty of physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Wagdy Younan wagdywilliam28@yahoo.com 00201000527217 7Ahmed elzyat street bein srayat .Egypt
City Postal code Country Position/Affiliation
Giza Egypt lecturer of physiotherapy department of of growth and development in pediatric and it is Surgeries. Deraya university
Role Name Email Phone Street address
Scientific Enquiries Nabil Abdel Aall nabil_45@hotmail.com 00201200133613 7Ahmed elzyat street bein srayat .Giza .Egypt
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical Basic Sciences department Faculty of Physical Therapy Cairo University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data summary of results Study Protocol 5 month period of time after publication Controlling access to data
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