Evaluation of contralateral limb cross education and high frequency repetitive trans-cranial magnetic stimulation on functional indices of affected upper limb in subacute stroke patients
The purpose of this study is comparison of 4 techniques on function of hand in stroke patients. The sample size was calculated as 40 hemiplegic patients, that after filling out a consent form, subjects participated in experiments. The subjects are randomly assigned into 4 groups. For first group routine physiotherapy, for the second group physiotherapy & cross education, for the third group physiotherapy & rTMS, and for the fourth group physiotherapy, cross education & rTMS is applied. Duration of treatment is 10 sessions ( 3 weeks). Function of hand is measured before and after treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011726056N1
Registration date:2016-08-28, 1395/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Farzaneh Moslemi Haghighi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36271551
Email address
moslemif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research affairs of Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of contralateral limb cross education and high frequency repetitive trans-cranial magnetic stimulation on functional indices of affected upper limb in subacute stroke patients
Public title
The effect of cross education and trans-cranial magnetic stimulation in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:hemiplegic patients aged between30-65 years; hemiplegia after first stroke;having 22-44 scale in Fugle- Meyer Scale ;
Exclusion criteria:having fracture, dislocation and subluxation in upper exterimity, rheumatoid diseases in upper exterimities; other neurologic diseases; limiting range of motionin upper exterimity; epilepsy; cardiac arythmia; implant in skull; aphasia
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Blv.
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SUMS.REC.1394.136
Health conditions studied
1
Description of health condition studied
hemiplegia
ICD-10 code
G81.9
ICD-10 code description
Hemiplegia, unspecified
Primary outcomes
1
Description
grip strength
Timepoint
before and after intervention
Method of measurement
grip dynamometer
2
Description
pinch strength
Timepoint
before and after intervention
Method of measurement
Pinch gauge
3
Description
dexturity
Timepoint
before and after intervention
Method of measurement
Box and Block Test
4
Description
muscle tone
Timepoint
before and after intervention
Method of measurement
Modified Ashworth Scale
5
Description
functional movement of hand
Timepoint
before and after intervention
Method of measurement
Fugle- Meyer Scale
Secondary outcomes
empty
Intervention groups
1
Description
for first group ( control group), routine physiotherapy for affected upper exterimity of hemiplegia is applied in 10 sessions ,3 times a week. routine physiotherapy sessions include joints range of motions, gentle stretching of hapertonic muscles, strengthening of muscle weakness, learning of activity daily living and functional electrical stimulation.
Category
Treatment - Other
2
Description
For the second group,The subject is seated, both arms are relaxed and unaffected elbow is flexed to a right angle, with the unaffected forearm is in nutral position and resting on a table. maximal grip force of unaffected hand is measured by grip dynamometer. Then, subject grasps unaffected hand with 60-70% of maximal voluntary contraction 30 times in each sessions. Each patient receives 10 treatment sessions (3 times a week) of cross education technique.in addition, Routine physiotherapy is performed in each session.
Category
Treatment - Other
3
Description
For the third group, HF- rTMS Is applied over the primary motor cortex for the fingers of the
lesional hemisphere. Each rTMS session consists of 2000 pulses. Site of stimulation on
the skull is defined as the location where the largest motor evoked potentials of the first dorsal interosseous muscle in the unlesioned upper exterimity are elicited on electromyography. the intensity of stimulation is set at 90% of
the motor threshold of the first dorsal interosseous muscle. Frequency of stimulation is 20 Hz and .Each patient receives 10 treatment sessions (3 times a week) of rTMS.
Routine physiotherapy is performed after the application of rTMS sessions.
Category
Treatment - Other
4
Description
For the fourth group cross education ( similar to second group), HF-rTMS (similar to third group) and physiotherapy is applied in each session.Each patient receives 10 treatment sessions (3 times a week).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotheray Department of Rehabilitation Sciences Faculty
Full name of responsible person
Farzaneh Moslemi Haghighi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Zand Blv.Shiraz, Fars, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?