Objectives: Determine the effect of electroacupressure on muscular motor function and power of pelagic upper extremity in patient with stroke. Design: Double blind clinical trial. Setting and conduct: The intervention is performed in three groups includes routine care, use of electroacupressure, and placebo. Electroacupressure is applied by wristbands with a metal button attached to the active electrode of TENS devices, on the P6 (Neiguan) point in internal surface of forearm and above internal groove of wrist. When the wristband button is placed on the opposite side of the P6 (Neiguan) point, it is the role of the placebo. Routine treatment includes physiotherapy routine in internal ward and ICU. Participants: Inclusion criteria are: (1) being over 35 years old; (2) upper extremity paralysis due to stroke; (3) having no other musculoskeletal disorders on the upper extremity; (4) patients with cognitive status so that they could have cooperated; (5) having no skin problem such as allergies and ulcers at the wristband site; (6) Physiotherapy is started for them; (7) maximum a week is passed their stroke; (8) having no recurrent stroke; (9) the patient is not received thrombolytic drugs; (10) having no stroke in the area of cerebellum and brain stem; (11) having no revarsible ischemic neurologic deficit (RIND). Exclusion criteria are: (1) patients with cardiac pacemakers; (2) patients with sensory aphasia; (3) patients with a history of narcotics addiction. Intervention: Interventions including routine care, use of electroacupressure, and placebo that are done in three groups. Main outcome measures (variables): motor function and muscular power of pelagic upper extremity.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201407228717N3
Registration date:2014-08-23, 1393/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-23, 1393/06/01
Registrant information
Name
Mohammad Reza Asgari
Name of organization / entity
Semnan University of Medical Sciences and Health and Treatment Services
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 3365
Email address
asgari@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Semnan University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of electroacupressure on motor function and muscular power of pelagic upper extremity in patient with stroke
Public title
The effect of electroacupressure on motor function and muscular power of pelagic upper extremity in patient with stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (1) being over 35 years old; (2) Upper extremity paralysis due to stroke; (3) No other musculoskeletal disorders on the upper limb; (4) Patients with cognitive status so that they could have cooperated; (5) having no skin problem such as allergies and ulcers at the wrist strap site; (6) physiotherapy should be started for them; (7) maximum a week passed they strokes; (8) no recurrent stroke; (9) the patient did not receive thrombolytic drugs; (10) not in cerebellum and brain stem stroke; (11) is not revarsible ischemic neurologic deficit (RIND). Exclusion criteria: (1) Patients with cardiac pacemakers; (2) Patients with sensory aphasia; (3) Patients with a history of drug addiction.
Age
From 35 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, subjects are assigned randomly and using the randomized block to the experimental, placebo, and controll groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in biomedical researches of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Semnan, Semnan Province, Iran
City
Semnan
Postal code
3519899951
Approval date
2014-07-08, 1393/04/17
Ethics committee reference number
469710/93
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
164
ICD-10 code description
Stroke
Primary outcomes
1
Description
Motor function of pelagic upper extremity
Timepoint
Before start intervention at the first session and after the intervention at the last session
Method of measurement
Part of evaluation of upper limb motor function and Hand of Fugl Meyer scale
Secondary outcomes
1
Description
Muscular power of pelagic upper extremity
Timepoint
Before start intervention at the first session and After the intervention, at the last session
Method of measurement
By manually dynamometer
Intervention groups
1
Description
First intervention (Routine care): In the control group patients receive routine care, after the doctor's orders to start physiotherapy, routine physiotherapy is performed for all patients. motor function and muscular power of pelagic upper extremity are measured by researcher before start intervention at the first session and after the intervention at the last session by using Fugl Meyer checklist and manually dynamometer.
Category
Other
2
Description
The second intervention (use of electroacupressure): In the intervention group, to applying the electroacupressure, the wristbands is closed on patients’ wrists so that its button is placed on the P6 point (Nei guan) on the inner surface of the forearm, about 2 inches (three fingers width) above the internal groove of wrist. Pressure is applied so that the patient does not feel pain or discomfort. Electrical stimulation is applied with wave length 200μs, frequency 20Hz, and intensity 2.5 times the threshold of patient sense by a metal button attached to the active electrode of TENS devices on the P6 (Neiguan) point. The intervention is performed for 10 minutes immediately after physiotherapy, five days per week and during two consecutive weeks. Motor function and muscular power of pelagic upper extremity are measured by researcher before start intervention at the first session and after the intervention at the last session by using Fugl Meyer checklist and manually dynamometer.
Category
Rehabilitation
3
Description
The third intervention (use of placebo): In the intervention group using placebo, wristbands is closed on patients’ wrists so that its button is placed on opposite of P6 point (Nei guan) on the back of the forearm. Active electrode (positive) of TENS device is connected to the metal buttons, device is turned on but does not give electrical stimulation. The intervention is performed for 10 minutes immediately after physiotherapy, five days per week and during two consecutive weeks. Motor function and muscular power of pelagic upper extremity are measured by researcher before start intervention at the first session and after the intervention at the last session by using Fugl Meyer checklist and manually dynamometer.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Internal and ICU wards of Semnan Kowsar hospital
Full name of responsible person
Mohammad Reza Asgari
Street address
Department of Internal and ICU wards, Kowsar hospital, Basij boulevard, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidy-Pour
Street address
Research and technology deputy of Semnan University of Medical Sciences, Basij boulevard, Semnan, Iran
City
Semnan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Asgari
Position
PhD in nursing, Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
3514743365
Phone
+98 23 3345 3365
Fax
Email
asgari5000@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
ِDr. Mohammad Reza Asgari
Position
PhD in nursing, Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
3514743365
Phone
+98 23 3345 3365
Fax
Email
asgari5000@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
ِDr. Mohammad Reza Asgari
Position
PhD in nursing, Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
3514743365
Phone
+98 23 3345 3365
Fax
Email
asgari5000@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)