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The effect of family-centered purposeful and early sensory stimulation on function and cognition rehabilitation in patients with disorder of consciousness after stroke

Protocol summary

Study aim
Determination of the effect of family-centered purposeful early sensory stimulation of function and cognition rehabilitation in patients with disorder of consciousness after stroke
Design
Two parallel group randomised trial with blocking and blinded
Settings and conduct
Visual stimulation is done by moving the flash light in patient's visibility and showing the colorful cards and telling him/her the name of the color, smelling stimulation is done with coffee or a known smell, tasting stimulation is done with blobbing lemon juice to sides of the patient's glossa, tactile stimulation is done by blobbing cotton on the hand's skin and then drawing simple shapes by finger and telling the patients the name of the shapes and hearing stimulation is done with sweet reminisceces. all of these stimulation are done by family member for 15 days and use the scales in days of 0, 5, 10 and 15. patients and analyst and person who collect the data with scales are blind.
Participants/Inclusion and exclusion criteria
72 hours after stroke age more than 18, GCS 5-10, without any brain attack, without visual and hearing problem, family adhesion, having a family member for doing the stimulations, not being pregnant women,without former stroke, not being under ventilation, not use t-pa therapy ( tissue plasminogen activator)
Intervention groups
case group: patients are stimulated 5 sense: visual, hearing, tactile, tasting and smelling by family member. control group: patients are cared with routine care in ICU ward
Main outcome variables
Function and cognition rehabilitation by use of GCS, FOUR Score and DRS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151004024342N6
Registration date: 2018-09-22, 1397/06/31
Registration timing: registered_while_recruiting

Last update: 2018-09-22, 1397/06/31
Update count: 0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Vida Shafipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
v.shafipour@mazuma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered purposeful and early sensory stimulation on function and cognition rehabilitation in patients with disorder of consciousness after stroke
Public title
The effect of family-centered purposeful and early sensory stimulation on function and cognition rehabilitation in patients with disorder of consciousness after stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
72 hours after stroke age more than 18 GCS 5-10 without any brain attack without visual and hearing problem family adhesion having a family member for doing the stimulations
Exclusion criteria:
pregnant women former stroke be under ventilation use t-pa therapy ( tissue plasminogen activator)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
blocking
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and analyst and the person who collect the data are blind
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Vice-Chancellor for Research, Mazandaran University of Medical Sciences
Street address
vesale shirazi avenue, amir mazandarani street, emem khomeini squer, sari
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.MAZUMS..REC.1397,1529

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome

Primary outcomes

1

Description
Function and Cognition Rehabilitation
Timepoint
Every 5 days for 15 days
Method of measurement
Gloscow Coma Scale (GCS); FOUR Score; Disability Rating Scale (DRS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 5 sense stimulation including visual stimulation with moving the flashlight in patient's visibility and showing the colorful cards them and telling them the color of the card, smelling stimulation with coffee or a known smell, hearing stimulation by sweet reminiscences, tasting stimulation bye blob the lemon juice to sides of the glossa, tactile stimulation is done by touching and blobbing cotton on the patient's skin and drawing simple shapes on the patient's skin and telling them the name of the shapes. all of these stimulation are done by a family member of the patients.
Category
Rehabilitation

2

Description
Control group: patients in this group are cared with ICU ward's routine cares.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Booali Sina hospital
Full name of responsible person
Lale Alipoor
Street address
Booali sina Hospital; Pasdaran Blvd; Sari
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3334 3011
Email
v.shafipour@mazuma.ac.ir

2

Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Vida Shafipour
Street address
Emam Ali hospital; Dr Javadian Blvd; Noor Ave;
City
Amol
Province
Mazandaran
Postal code
46158-86332
Phone
+98 11 4426 4661
Email
lale.alipoor@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vida Shafipour
Street address
Mazandaran University of Medical Science; Valiasr Ave; Emam Sqe; Sari
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4000
Email
vidashafipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Vida Shafipour
Position
Phd.Educational Nursing-faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 151 9667
Fax
Email
v.shafipour@mazuma.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vida SHafipour
Position
Phd.Educational Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
v.shafipour@mazuma.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vida Shafipour
Position
Phd.Educational Nursing-faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 151 9667
Fax
Email
v.shafipour@mazuma.ac.ir
Web page address

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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