Protocol summary

Summary
Inclusion criteria: hemiplegia in dominant and spastic hand; at least 2 months after stroke; modified ashword scale 2-3; men and women with stroke in the age range 30-65; normal vision in perimetry test; MMSE score above10 and NIHSS score 7-15; range of motion in wrist and elbow Exclusion criteria: stroke origin heart emboli; heart pace maker and arrhythmia; fracture in upper limb; neurologic diseases such as Parkinson disease, Multiple Sclerosis and epilepsy; implant in skull; problem in occipital, limbic system and complementary area and unable to accompany for 4 weeks Purpose: Recent studies have shown effects of rTMS 1 Hz and joy stick on improve hand function of patients with stroke. The aim of this study is compare of the effect of combination of rTMS and joy stick simultaneously on the wrist and elbow joints movements and compare the results with use of magnetic stimulation, tracking exercise with joy stick and routine physical therapy. Design: Not blinded. Methods: Patients will be randomly divided into 4 groups and receive 10 sessions 70 minutes treatment, 4 sessions per week. Participants: Men and women with stroke in the age range 30-65, at least 2 months after stroke, with no cardiac source of embolism, heart pace maker and arrhythmia, Epilepsy and implant in skull. Interventions: 4 treatment groups consist of minutes routine rehabilitation(upper limb exercise therapy), treatment with rTMS 1 Hz, treatment with joy stick and treatment with combination of rTMS and joy stick, will treated for 10 sessions 70 minutes treatment, 4 sessions per week. Variables: Improvement of involved hand function, grip force, range of motion, spasticity, accuracy, time and distance of test will measured.

General information

Acronym
Trans magnetic stimulation and stroke
IRCT registration information
IRCT registration number: IRCT201111088027N1
Registration date: 2011-12-20, 1390/09/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Poopak Moatamed Vaziri
Name of organization / entity
Pardis Physical Therapy Center
Country
Iran (Islamic Republic of)
Phone
+98 8844335488424094
Email address
poopakmoatamedv@yahoo.com
Recruitment status
Recruitment complete
Funding source
Pardis Physical Therapy Center
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation a new therapeutic approach to improve motor function of upper limb in hemiplegia patients based on combination external repetitive trans magnetic brain stimulation and tracking exercises with modified joy stick
Public title
The effect of trans magnetic stimulation to improve motor function of upper limb in hemiplegia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemiplegia in dominant and spastic hand; at least 2 months after stroke; modified ashword scale 2-3; men and women with stroke in the age range 30-65; normal vision in perimetry test; MMSE score above10 and NIHSS score 7-15; range of motion in wrist and elbow Exclusion criteria: stroke origin heart emboli; heart pace maker and arrhythmia; fracture in upper limb; neurologic diseases such as Parkinson disease, Multiple Sclerosis and epilepsy; implant in skull; problem in occipital, limbic system and complementary area and unable to accompany for 4 weeks
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: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Medical Sciences Department- Jalale ale ahmad avenue
City
Tehren
Postal code
175-14115
Approval date
2011-01-10, 1389/10/20
Ethics committee reference number
52/84482

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
G46*
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases

Primary outcomes

1

Description
Improve grip force of involve hand
Timepoint
Pre and post of treatment
Method of measurement
Dynamometer

2

Description
Improve function of involve hand
Timepoint
Pre and post of treatment
Method of measurement
Fugle myer score- barthel score- NIHSS score

3

Description
Improve range of motion of joints of involve hand
Timepoint
Pre and post of treatment
Method of measurement
Wrist robo hab

4

Description
Improve spasticity of involve hand
Timepoint
Pre and post of treatment
Method of measurement
Wrist robo hab

5

Description
Improve accuracy, time and distance of test in involve hand
Timepoint
Pre and post of treatment
Method of measurement
Joy stick

Secondary outcomes

empty

Intervention groups

1

Description
10 sessions 70 minutes treatmant, 4 sessions per week Group 1(control): Per session, 30 minutes routine rehabilitation(upper limb exersice therapy), 20 minutes sham rTMS, 20 minutes exersice with sham joy stick
Category
Rehabilitation

2

Description
10 sessions 70 minutes treatmant, 4 sessions per week Group 2: Per session, 30 minutes routine rehabilitation(upper limb exersice therapy), 20 minutes rTMS 1 Hz on M1 of healthy hemisfer, 20 minutes exersice with sham joy stick
Category
Rehabilitation

3

Description
10 sessions70 minutes treatmant, 4 sessions per week Group 3: Per session, 30 minutes routine rehabilitation(upper limb exersice therapy), 20 minutes sham rTMS , 20 minutes exersice by joy stick in front of monitor and drawing the different charts.
Category
Rehabilitation

4

Description
10 sessions 70 minutes treatmant, 4 sessions per week Group 4: Per session, 30 minutes routine rehabilitation(upper limb exersice therapy), 20 minutes rTMS 1 Hz on M1 of healthy hemisfer , 20 minutes exersice by joy stick in front of monitor and drawing the different charts
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Poopak Moatamed Vaziri
Street address
First floor, Number 3, kakuti alley, Shariati street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pardis Physical Therapy Center
Full name of responsible person
Morteza Noorii
Street address
First floor- Nomber 3- Kakuti alley- Shariati street
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pardis Physical Therapy Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Pardis Physical Therapy Center
Full name of responsible person
Poopak Moatamed Vaziri
Position
PhD
Other areas of specialty/work
Street address
First floor, Number 3, kakuti alley, Shariati street
City
Tehran
Postal code
1639648813
Phone
+98 21 8844 3354
Fax
-
Email
poopakmoatamedv@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pardis Physical Therapy Center
Full name of responsible person
Poopak Moatamed Vaziri
Position
PhD
Other areas of specialty/work
Street address
First floor, Number 3, kakuti alley, Shariati street
City
Tehran
Postal code
1639648813
Phone
+98 21 8844 3354
Fax
-
Email
poopakmoatamedv@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Pardis Physical Therapy Center
Full name of responsible person
Poopak Moatamed Vaziri
Position
PhD
Other areas of specialty/work
Street address
First floor, Number 3, kakuti alley, Shariati street
City
Tehran
Postal code
1639648813
Phone
+98 21 8844 3354
Fax
-
Email
poopakmoatamedv@yahoo.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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