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.: PACTR202311757805625 Date of Registration: 28/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Repetitive Peripheral Magnetic Stimulation for Improving Upper Limb Function in Poststroke Hemiparesis
Official scientific title Repetitive Peripheral Magnetic Stimulation for Improving Upper Limb Function in Poststroke Hemiparesis
Brief summary describing the background and objectives of the trial Stroke is one of the leading causes of disability worldwide, with hand and arm weakness, affecting the patient's daily activities and quality of life. Recently, repetitive Peripheral Magnetic Stimulation (rPMS) was found to enhance neuroplasticity and motor recovery post-stroke hemiparesis via its deep proprioceptive stimulation and simulation of lost voluntary movement. OBJECTIVE: To determine the therapeutic effect of rPMS on the functional improvement of the upper limb in patients with hemiparesis following cerebrovascular insult and to compare the effect of therapy in subacute and chronic cases.
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 Rehabilitation
Anticipated trial start date 30/05/2022
Actual trial start date 30/05/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL https://doi.org/10.1186/s43166-023-00204-x
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sham Repetitive peripheral magnetic stimulation 5 sessions per week 3 weeks. specialized program for placebo trials, which makes the coil work passively, making only sound without real pulses 40 Placebo
Experimental Group Real Repetitive Magnetic stimulation 5 sessions per week 3 weeks rPMS was applied over 4 muscle groups: 1- Shoulder abductors. 2- Elbow extensors. 3- Wrist extensors. 4- Supinator muscle. Intensity was set at 10 % above the level that evoked wrist movement taken at rest. Average for all cases was between 35-45%. Active Group: received Real rPMS, its parameters were: frequency 30Hz, Work period 5s. 30 trains, a total of 4500 pulse per muscle, with a total of 30 minutes for the whole session 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) hemiparesis caused by a cerebrovascular insult. (2) weakness of the upper limbs. (3) Subacute cases: 6 weeks post cerebrovascular insult. (4) Chronic cases: more than 24 weeks post cerebrovascular insult. (5) shoulder abductors muscle power at least grade 2. (6) Full passive range of motion. (7) Spasticity with Modified Ashworth scale < grade 3. (1) Any metal implant within the stimulation area, or medically implanted devices such as cardiac pacemakers or medication pumps. (2) pregnancy. (3) comorbidity with other neurodegenerative, neurological, or orthopedic disorders. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 29/05/2022 Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Abbasia square Cairo 117157 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The upper limb motor function was assessed by Fugl Myer assessment score. We functionally categorized the severity of upper limb affection as mild, moderate and severe using FMS for the upper limb assessment; mild 0-28, moderate 29-42, and severe 43-66 At Baseline and after 3 weeks
Primary Outcome Ultrasound (US) assessment of the extensor digitorum muscle, with measurement of cross-sectional area (CSA) and subcutaneous tissue thickness (STT). At baseline and after 3 weeks
Secondary Outcome ADLs for the upper extremity, which was measured using self-care of the FIM, since upper extremity function is closely related to self-care rather than other ADL items At baseline and after 3 weeks
Secondary Outcome Spasticity using Modified Ashworth Scale (MAS) to elbow: flexors, wrist and finger: flexors, and forearm pronators muscles At baseline and after 3 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Abbassia square Cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Shereen Ismail Fawaz 2 Maryland buildings. Gesr El Suez street. Flat 901 Cairo 11757 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shereen Ismail Fawaz 2 Maryland bukdings. Gesr El Suez street Cairo 11757 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shereen Fawaz shereen_fawaz@med.asu.edu.eg +201001242964 2 Maryland buildings. Gesr el Suez street,
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Ain Shams university
Role Name Email Phone Street address
Public Enquiries Heba Gamal Eldin Saber hebagesaber@yahoo.co.uk 00201226694553 Misr el Gedeeda
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Amr Saeed Zaki amrsaadawy@med.asu.edu.eg 00101010006721 Orabi street
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available: yes. All of the individual participant data collected during the trial, after de-identification will be shared. Other documents available: study protocol, statistical analysis plan, informed consent form and ethics committee approval will be available through the link and according to the time frame. Data will be shared with anyone who wishes to access the data for any purpose. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available 6 months after publication and end 36 months after publication Data will be accessed through the link
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://osf.io/c6j94/?view_only=98f6ddd3c4414ca999ed1bbc7e562da8 Yes 12/11/2023 10/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 22/11/2023 Result - 22/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://erar.springeropen.com/articles/10.1186/s43166-023-00204-x
Changes to trial information