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.: PACTR201907475143673 Date of Approval: 05/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Repetitive Transcranial Magnetic Stimulation on Motor Functions in Multiple Sclerosis Patients
Official scientific title Effect of Repetitive Transcranial Magnetic Stimulation on Motor Functions in Multiple Sclerosis Patients
Brief summary describing the background and objectives of the trial This study was conducted to assess the effect of repetitive transcranial magnetic stimulation on motor functions in multiple sclerosis patients.•Thirty patients with multiple sclerosis from both sexes recruited from outpatient clinic, Faculty of Physical Therapy and multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University. The diagnosis done by a neurologist and confirmed by Magnetic Resonance Imaging (MRI). The selected patients were randomly assigned into two equal groups :study group (A), and control group (B). The treatment was conducted five consecutive days per week for two weeks. The study group (A) received repetitive transcranial magnetic stimulation plus selected physiotherapy program (stretching exercise, Graduated active exercises, balance and gait training). The control group (B) received only the same physiotherapy program.All patients assessed pre and post treatment using 5 repititions sit to stand test and isokinetic dynamometer.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 25/06/2017
Actual trial start date 25/06/2017
Anticipated date of last follow up 20/03/2019
Actual Last follow-up date 28/06/2019
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Repititive transcranial magnetic stimulation Five times per week. two weeks. MagStim magnetic stimulator connected with a figure-of-eight coil was used to deliver low-frequency repititive transcranial magnetic stimulation over the scalp site corresponding to the leg area of primary motor cortex at frequency of 1 Hz , Stimulation intensity was set to 90% of the resting motor threshold and the total number of pulses was 900. 15
Control Group Selected physical therapy program Five times per week. Two weeks. The selected physiotherapy program consisted of stretching exercise, Graduated active exercises, balance and gait training. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Definite diagnosis of relapsing-remitting multiple sclerosis, fulfilled the Revised McDonald's criteria for diagnosis of multiple sclerosis 2010 (Polman et al., 2011). 2) A score of 2.0 to 4.0 on the Expanded Disability Status Scale (EDSS). 3) Age ranges from 20 – 40 years old. 4) All the patients are in the remission period. 5) Last attack occurs at least since two months. 6) All the Patients are ambulant. 7) All patients are receiving the same medical treatment. 8) Patients are medically stable. 9) Ability to understand and follow instructions. 10) The Patients are free from any secondary complications such as contractures or deformities. 11) The patients recruited with informed consent. 1) Any other neurological deficits or orthopedics abnormalities preventing participation in the study. 2) Patients who have any other inflammatory or infectious diseases, e.g. arthritis. 3) Pregnant female patients. 4) Cardiovascular and Pulmonary diseases. 5) Patients with active or uncontrolled pathologies (i.e. cancer). 6) Patients in acute relapse stage. 7) Patients with cognitive deficits. 8) Patients with any psychiatric disease. 9) Patients with magnetic devices or any other implanted device. 10) History of seizure. Adult: 19 Year-44 Year 20 Year(s) 40 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 06/06/2017 Research ethical committee Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza Giza 12624 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Isokinetic dynamometer which measures the peak toque, peak torque/body weight (PK/BW), time to peak torque, total work and average power. Pre and post treatment.
Secondary Outcome Five repititions sit to stand test which measures the functional lower extremity strength. Pre and post treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical Therapy Cairo University 7 Ahmed ELzayat Street, Bien Elsarayat, Dokki, Giza. Giza. 12624 Egypt
Kasr Al Aini Faculty of medicine Cairo university. Al-Saray street El manial Cairo Cairo 11956 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelaziz Elsherif 7 Ahmed ELzayat St. Bien Elsarayat, Dokki, Giza. Giza 12624 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university. El-Gamma at Al Orman Giza Governorate. Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moshera Hassan Darwish 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza 12624 Egypt
Mohamed Soliman El Tamawy 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza 12624 Egypt
MYE ALI BASHEER 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza 12624 Egypt
Heba Ahmed Khalifa 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza 12624 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelaziz Elsherif Abdelaziz.elsherif@cu.edu.eg 0020237617691 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza
City Postal code Country Position/Affiliation
Giza 12624 Egypt Assistant Lecturer at faculty of physical therapy cairo university.
Role Name Email Phone Street address
Scientific Enquiries MYE BASHEER Myebasheer@hotmail.com 0020237617691 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza
City Postal code Country Position/Affiliation
Giza 12624 Egypt Assistant Professor.
Role Name Email Phone Street address
Public Enquiries Heba Khalifa Dr_hobi@yahoo.com 0020237617691 7 Ahmed ELzayat St. Bien Elsarayat, Dokki Giza
City Postal code Country Position/Affiliation
Giza 12624 Egypt Lecturer at faculty of physical therapy cairo university.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Thirty patients with multiple sclerosis from both sexes recruited from outpatient clinic, Faculty of Physical Therapy and multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University. With the following inclusion criteria:Definite diagnosis of relapsing-remitting multiple sclerosis fulfilled the Revised McDonald's criteria for diagnosis of multiple sclerosis 2010 (Polman et al., 2011), score of 2.0 to 4.0 on the Expanded Disability Status Scale (EDSS), age ranges from 20 – 40 years old, all patients are in the remission period, last attack occurs at least since two months, all the Patients are ambulant, all patients are receiving the same medical treatment, patients are medically stable,ability to understand and follow instructions, Patients are free from any secondary complications such as contractures or deformities, patients recruited with informed consent. Study Protocol Thirty patients with multiple sclerosis from both sexes recruited from outpatient clinic, Faculty of Physical Therapy and multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University. With the following inclusion criteria:Definite diagnosis of relapsing-remitting multiple sclerosis fulfilled the Revised McDonald's criteria for diagnosis of multiple sclerosis 2010 (Polman et al., 2011), score of 2.0 to 4.0 on the Expanded Disability Status Scale (EDSS), age ranges from 20 – 40 years old, all patients are in the remission period, last attack occurs at least since two months, all the Patients are ambulant, all patients are receiving the same medical treatment, patients are medically stable,ability to understand and follow instructions, Patients are free from any secondary complications such as contractures or deformities, patients recruited with informed consent. The selected patients were randomly assigned into two equal groups :study group (A), and control group (B). The treatment was conducted five consecutive days per week for two weeks. The study group (A) received repetitive transcranial magnetic stimulation plus selected physiotherapy program (stretching exercise, Graduated active exercises, balance and gait training). The control group (B) received only the same physiotherapy program.All patients assessed pre and post treatment using 5 times sit to stand test and isokinetic dynamometer. Thirty patients with multiple sclerosis from both sexes recruited from outpatient clinic, Faculty of Physical Therapy and multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University. With the following inclusion criteria:Definite diagnosis of relapsing-remitting multiple sclerosis fulfilled the Revised McDonald's criteria for diagnosis of multiple sclerosis 2010 (Polman et al., 2011), score of 2.0 to 4.0 on the Expanded Disability Status Scale (EDSS), age ranges from 20 – 40 years old, all patients are in the remission period, last attack occurs at least since two months, all the Patients are ambulant, all patients are receiving the same medical treatment, patients are medically stable,ability to understand and follow instructions, Patients are free from any secondary complications such as contractures or deformities, patients recruited with informed consent.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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