To examine the effect of sitting balance exercises on dependency level among patients with stroke
Design
A nonprobability (purposive) sampling method consist of 60 patients acute stroke was included in this study, the participants will be assigned randomly into two groups: experimental group and control group (conventional care).
Settings and conduct
was conducted at the medical words of Imam Al-Hussein Medical City in Holy Kerbala, Iraq.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
-Had a stroke in the previous 2 months (ischemic or hemorrhagic, all brain regions)
-We’re not able to stand independently for more than 1 minute
Exclusion Criteria:
-Tetraplegia or hemiplegia
-Had vestibular deficits or vertigo
Intervention groups
The level of dependency was measured using a Modified Barthel index before application of the interventional protocol. Then a sitting balance exercises was performed 15-30 minutes through two sessions per day for 14th days
Main outcome variables
Minimize dependency level after stroke
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058671N1
Registration date:2023-07-08, 1402/04/17
Registration timing:retrospective
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Suror Khalil
Name of organization / entity
College of Nursing/ University of Kerbala
Country
Iraq
Phone
+964 773 569 2723
Email address
seror.kh@s.uokerbala.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-01, 1401/11/12
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Early Balance Exercise on Dependency Level among Patients with Stroke
Public title
Early Balance Exercise on Dependency Level among Patients with Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Had a stroke in the previous 2 months (ischemic or hemorrhagic, all brain regions) and were attending inpatient rehabilitation
Could sit independently for at least 1 minute without support
We’re not able to stand independently for more than 1 minute
Exclusion criteria:
Cognitive deficits
Tetraplegia or hemiplegia
Had vestibular deficits or vertigo
Age
From 19 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Ethics committee in college of nursing at university of kerbala
Street address
Baghdad street
City
AL-Musayib district
Postal code
56001
Approval date
2023-11-06, 1402/08/15
Ethics committee reference number
1506.68
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified
Primary outcomes
1
Description
Primary outcome variable is the level of dependency among stroke patients that can be minimized by applying sitting balance exercises
Timepoint
before intervention and two weeks after intervention
Method of measurement
Modified Barthel Index Scale will be used to assess level of dependency
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Interventional groups consist of 30 patients with acute stroke , after assessing the level of dependency using a Modified Barthel index.Then a sitting balance exercises was performed 15-30 minutes through two sessions per day for 14th days, the sitting balance exercises was consisted of five exercises: shift weight side to side, reaching, seated leg lift, single-leg knee extensions, and reach with clasped hands. The levels of dependency were measured immediately after the completion of the intervention; all participants continued to receive their conventional stroke care.
Category
Treatment - Other
2
Description
Control group: consist of 30 patients with acute stroke , after assessing the level of dependency using a Modified Barthel index. Then participants were received conventional stroke care for14th days period. The levels of dependency were measured immediately after the completion of 14th days period.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Al- Hussein Medical City
Full name of responsible person
Karbala Health Directorate
Street address
Baghdad street
City
AL-Musayib district
Postal code
56001
Phone
+964 773 569 2723
Email
seror.kh@s.uokerbala.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Karbala
Full name of responsible person
Suror Khalil Ibrahim
Street address
Baghdad street
City
AL-Musayib district
Postal code
56001
Phone
+964 773 569 2723
Email
seror.kh@s.uokerbala.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Karbala and the author of trails is the funding source
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
University of Karbala
Full name of responsible person
Suror Khalil Ibrahim
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adult Nursing Department
Street address
Baghdad street
City
AL-Musayib district
Province
Babylon
Postal code
56001
Phone
+964 773 569 2723
Email
seror.kh@s.uokerbala.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Karbala
Full name of responsible person
Suror Khalil Ibrahim
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adult Nursing Department
Street address
Baghdad street
City
AL-Musayib district
Province
Babylon
Postal code
56001
Phone
+964 773 569 2723
Email
seror.kh@s.uokerbala.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Karbala
Full name of responsible person
Suror Khalil Ibrahim
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Adult Nursing Department
Street address
Baghdad street
City
AL-Musayib district
Province
Babylon
Postal code
56001
Phone
+964 773 569 2723
Email
seror.kh@s.uokerbala.edu.iq
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be the results of the Modified Barthel index that measure patients' dependency level in both the control and intervention groups.
When the data will become available and for how long
God Willing, once the article is published, the data will be available after 6 months of publication. If the article will be published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals.
To whom data/document is available
With academic nurses and any researcher who is interested in the data.
Under which criteria data/document could be used
The data could be used after getting permission via email. Also, users need to acknowledge the owner.
From where data/document is obtainable
Users can ask for the data and permission via email.
Suror Khalil Ibrahim is the corresponding author. She will
contact whoever he requests the information from. His
email is seror.kh@s.uokerbala.edu.iq
Suror Khalil Ibrahim study at the University of Kerbala/College of Nursing.
The address is AL-Musayib district, Babylon, Iraq.
What processes are involved for a request to access data/document
Suror Khalil Ibrahim is the corresponding author. She will
contact whoever he requests the information from. His email is seror.kh@s.uokerbala.edu.iq