The effect of training skills for using the mobility assistive devices on self-esteem and self-efficacy of hospitalized patients with stroke
Design
The study is a randomized single blind controlled trial
Settings and conduct
This study will be done at neurology ward of Kashani hospital in Shahre-kord on post stroke patients. Participants will be allocated into intervention and control groups using "random allocation" software. Intervention group will receive educations on how to use mobility assistive devices. Control group will receive only routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of stroke by a neurologist,
Passed 48 hours from the onset of stroke. (the acute stage be passed),
Having muscle force of 3.5 or 4.5,
Patient's age should be less than 70 years old,
willingness to participate in this study.
Intervention groups
Patients participating in this study will be divided into intervention and control groups. Intervention group will receive educations about how to use mobility assistive devices (walker and walking stick). control group will receive only routine care.
Main outcome variables
Self-efficacy, self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180419039362N1
Registration date:2018-06-28, 1397/04/07
Registration timing:registered_while_recruiting
Last update:2018-06-28, 1397/04/07
Update count:0
Registration date
2018-06-28, 1397/04/07
Registrant information
Name
Bakhtiar Peikfalak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5982
Email address
ba.peikfalak@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educating skills on using mobility assistive devices on self-esteem and self-efficacy of patients with stroke
Public title
The effect of training on self-efficacy and self-esteem in stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of stroke by a neurologist
Passed 48 hours from the onset of stroke (acute stage be passed)
Having muscle force of 3.5 or 4.5
Patient's age should be less than 70 years old
willingness to participate in this study
Exclusion criteria:
Having verbal and visual cognitive impairment, previous dementia, global aphasia or any visual impairment
Having any underlying disease that can cause motor dysfunction
History of previous stroke
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by simple sampling method and then will be randomly assigned into control or intervention group based on numbers generated by "Random allocation" software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer will not play any role in implementing interventions and will be unaware of what group is intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar blind alley, Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IRUSWRREC.1396.327
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy score in Sherer's questionnaire
Timepoint
before and two weeks after interventions
Method of measurement
Sherer's self efficacy questionnaire
2
Description
self-esteem score in Rosenberg questionnaire
Timepoint
before and two weeks after interventions
Method of measurement
Rosenberg's self steem questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group complete self-efficacy and self-esteem questionnaires before discharge from the hospital and in addition to receiving routine therapies, they also receive training on using assistive device. They complete the questionnaires after two weeks.
Category
Rehabilitation
2
Description
Control group: This group complete self-efficacy and self-esteem questionnaires before discharge from the hospital and they receive just the usual treatment within two weeks. After that, they complete the questionnaires again.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated by Shahrekord University of Medical Sciences
Full name of responsible person
Bakhtiar Peikfalak
Street address
Ayatollah Kashani Hospital, Shreati Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658699
Phone
+98 38 3333 5982
Email
B.peikfalak@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sayyed Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Ba.peikfalak@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for Research, Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Bakhtiar Peikfalak
Position
Headnurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 11,20/1 Alley, Shariati Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658699
Phone
+98 38 3333 5982
Email
Ba.peikfalak@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Bakhtiar Peikfalak
Position
Headnurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 11,20/1 Alley, Shariati Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658699
Phone
+98 38 3333 5982
Email
Ba.peikfalak@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Bakhtiar Peikfalak
Position
Headnurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 11,20/1 Alley, Shariati Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814658699
Phone
+98 38 3333 5982
Email
Ba.peikfalak@uswr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shareable after making them unidentifiable
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Employed researchers in universities and scientific centers, students
Under which criteria data/document could be used
If a researcher wants to know about methodology of this study.
From where data/document is obtainable
To the e-mail address of the researcher
ba.peikfalak@uswr.ac.ir
What processes are involved for a request to access data/document
Applicant will send his/her email and phone number and about 2 weeks after Validation, data will send to him/her.