Effects of high-frequency repetitive transcranial magnetic stimulation combined with Physiotherapy in Rehabilitation of Functional outcomes, Balance, Quality of life and depression in stroke patients: A randomized controlled trial.
Comparison of effects of treatment with HF-rTMS(High-Frequency Repetitive Transcranial Magnetic Stimulation) and rehabilitation, with rehabilitation alone, on balance, functional independence, quality of life and depression of patients after stroke
Design
Two arms parallel-group randomized trial on 36 patients with blinded outcome assessment
Settings and conduct
Stroke patients are visited in the specialty clinic of Emam Reza hospital of Tabriz by an experienced neurologist and then referred for initial assessments. Patients undergo interventions based on their group in Physigo Rehabilitation center, and assessment is done immediately after, and 1 month after interventions.
Neurologist, researcher, outcome evaluators and the statistician are blinded.
Participants/Inclusion and exclusion criteria
Adult patients with proven ischaemic or hemorrhagic stroke, suffering from movement disorders of lower limbs; without a past history of epilepsy or other contraindications of rTMS
Intervention groups
Subjects that conform to inclusion criteria are allocated to these two groups:
1- Intervention: Real HF-rTMS and conventional rehabilitation
2- Control: Sham HF-rTMS and conventional rehabilitation
Main outcome variables
Berg Balance Scale(BBS) score; Berg Depression Short Inventory (BDI-S) score;
Adults' Activities of Daily Living (ADL) Questionnaire score;
WHO Short-form Quality of Life Questionnaire (WHOQOL-BREF) score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100720004422N8
Registration date:2020-09-01, 1399/06/11
Registration timing:prospective
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Seyed Kazem Shakouri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3518
Email address
shakourik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of high-frequency repetitive transcranial magnetic stimulation combined with Physiotherapy in Rehabilitation of Functional outcomes, Balance, Quality of life and depression in stroke patients: A randomized controlled trial.
Public title
Effects of rTMS in rehabilitation after stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Proven CVA via MRI
At least 3 months after stroke
Stroke in MCA artery
Motor disorder in lower limbs due to recent stroke
Mild to moderate disorder of balance measured by Berg balance scale
Exclusion criteria:
Flaccid paraplegia
Presence of a cardiac pacemaker, cochlear implant or any metal implant in patient's skull
Previous treatment sessions with rTMS
History of severe psychiatric disorders, including suicidal thoughts
Pregnancy
History of epilepsy
History of other Neurologic disorders of balance
Consumption of drugs with a potential disruptive effect on patient's balance
Recent brain or spinal cord surgery
Recent brain or spinal cord surgery
Severe musculoskeletal disorders of lower limbs
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS) with block sizes of 2 and 4. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Double blinded
Blinding description
An independent researcher will randomise eligible participants. The researcher administering rTMS will be unblinded. To ensure allocation concealment, the independent researcher (randomiser) will provide allocation details (stimulation type) via a participant ID-coded email to the rTMS administrator immediately before the rTMS session. Participants will be remained blind to stimulation type until the end of procedures, as the researcher conducting assessments.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences central offices building No.2, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166969396
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.TBZMED.REC.1399.069
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Berg Balance Scale Score
Timepoint
Before Intervention, After Intervention, After 1 month
Method of measurement
Berg Balance Scale Score
2
Description
Berg Depression Short Inventory (BDI-S) score
Timepoint
Before Intervention, After Intervention, After 1 month
Method of measurement
Berg Depression Short Inventory (BDI-S) score
3
Description
Adults activities of daily living Questionnaire
Timepoint
Before Intervention, After Intervention, After 1 month
Method of measurement
Adults activities of daily living Questionnaire Score
4
Description
WHO Short-form Quality of Life Questionnaire (WHOQOL-BREF) score
Timepoint
Before Intervention, After Intervention, After 1 month
Method of measurement
WHO Short-form Quality of Life Questionnaire (WHOQOL-BREF) score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 sessions of HF-rTMS, delivered to lesional primary motor cortex area (M1), Frequency is set to 10 HZ. Dose for every session is 1000 pulses delivered in 10 trains of 10 seconds, with 50 seconds of rest in between. The total time for every session is 10 minutes. Patients undergo conventional rehab for stroke such as ROM and strengthening exercises, sitting and standing training, gait training with mirror and electrical stimulation based on the severity of symptoms.
Category
Rehabilitation
2
Description
Control group: Sham rTMS sessions are performed with a protocol similar to the intervention group, although the orientation of the coil is different and the intensity is set o minimum and simulated sounds are played through a speaker. The rehabilitation protocol is the same as the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine & Rehabilitation Clinic of Emam Reza Hospital
Full name of responsible person
Seyyed Kazem Shakouri
Street address
Physical medicine and rehabilitation ward, Emam Reza Hospital, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166969396
Phone
+98 41 3380 5274
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
Attar Neyshaburi St., Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166969396
Phone
+98 41 3336 4667
Fax
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kiarash Kordshakeri
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and rehabilitation ward, Emam Reza Hospital, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166969396
Phone
+98 41 3380 5274
Email
kiarash.shakeri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kiarash Kordshakeri
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and rehabilitation ward, Emam Reza Hospital, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166969396
Phone
+98 41 3380 5274
Email
kiarash.shakeri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kiarash Kordshakeri
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and rehabilitation ward, Emam Reza Hospital, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166969396
Phone
+98 41 3380 5274
Email
kiarash.shakeri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available