The objective of this study is to compare the effects of modified otago exercises and Action observation therapy on balance and postural stability in sub-acute stroke
Design
Randomized Clinical Trial, Single blinded study
Settings and conduct
This study will be conducted in Society hospital Lahore
single blinded study , Participant will be blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients should be diagnosed with stroke;
both male and female.
Participant’s Age will be between 45 to 60 years
patients should be able to walk at least 10 meters.
Patients should be able to understand and follow instruction, mini mental status examination (MMSE)>24.
Exclusion criteria:
If patient has any other neurologic disease other than stroke
Any auditory or visual deficit that can affect data collection of this study
Patient having any abnormality in the vestibular System.
Patients having any other orthopedic conditions
Intervention groups
Group A: Experimental group (n=19) Group A will be treated by modified otago exercise program and Conventional physical therapy. A session of 40 minutes for 6 weeks including 3 sessions per week will be given to each patient. 10 minutes of conventional treatment will be given to every participant and then 30 minutes of modified otago exercise program.
Experimental group (n=19)
Group B will be treated by Action Observation Therapy and Conventional physical therapy 40 minutes session will be given 3 times per week for 6 weeks. Prior to Action observation therapy patient will receive session of conventional physical therapy of 10 minutes.
Main outcome variables
Balance
Postural stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240505061662N1
Registration date:2024-05-17, 1403/02/28
Registration timing:registered_while_recruiting
Last update:2024-05-17, 1403/02/28
Update count:0
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Nazima Tariq
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 340 4900463
Email address
nazimatariq96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-15, 1403/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF MODIFIED OTAGO EXERCISES VERSUS ACTION OBSERVATION THERAPY ON BALANCE AND POSTURAL STABILITY IN SUB-ACUTE STROKE
Public title
EFFECTS OF MODIFIED OTAGO EXERCISES VERSUS ACTION OBSERVATION THERAPY ON BALANCE AND POSTURAL STABILITY IN SUB-ACUTE STROKE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be diagnosed with stroke
Both male and female.
Participant’s Age will be between 45 to 60 years
Patients should be able to walk at least 10 meters
Patients should be able to understand and follow instruction, mini mental status examination (MMSE)>24
Exclusion criteria:
If patient has any other neurologic disease other than stroke
Any auditory or visual deficit that can affect data collection of this study
Patient having any abnormality in the vestibular System.
Patients having any other orthopedic conditions
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 38 patients will be recruited according to convenience sampling into two intervention groups based on inclusion and exclusion criteria. Patients will be randomized through Lottery method into Group A (n = 19) and Group B (n = 19).
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant will be blinded in this study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah international university
Street address
Gulberg Lahore
City
Lahore
Postal code
54660
Approval date
2024-05-05, 1403/02/16
Ethics committee reference number
F22C14G37036
Health conditions studied
1
Description of health condition studied
Sub-acute stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Balance
Timepoint
Outcome will be measured after 6 weeks of intervention
Method of measurement
Berg balance scale will be using for pre and post assessment of variable
2
Description
Postural stability
Timepoint
postural stability will be measured after 6 weeks of treatment
Method of measurement
The postural Assessment Scale for Stroke patients (PASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A will be treated by modified ottago exercise program and Conventional physical therapy. A session of 40 minutes for 6 weeks including 3 sessions per week will be given to each patient. 10 minutes of coneventional treatment will be given to every participant and then 30 minutes of modified otago exercise program.
Category
Rehabilitation
2
Description
Intervention group: Group B will be treated by Action Observation Therapy and Conventional physical therapy 40 minutes session will be given 3 times per week for 6 weeks. Prior to Action observation therapy patient will receive session of conventional physical therapy of 10 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Society Hospital
Full name of responsible person
Nazima Traiq
Street address
Nabipura, Lahore
City
Lahore
Postal code
05480
Email
tariqnazima@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
Dr Sana Riaz
Street address
Gulberg , Lahore
City
Lahore
Postal code
54660
Phone
+92 340 4900463
Email
Sana.rcrs@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah international university
Proportion provided by this source
100
Public or private sector
Private
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
Riphah international university
Full name of responsible person
Nazima Tariq
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
gulberg , lahore
City
lahore
Province
punjab
Postal code
54660
Phone
+92 340 4900463
Email
tariqnazima@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Nazima Tariq
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
gulberg ,lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 340 4900463
Fax
Email
nazimatariq96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Nazima Tariq
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Gulberg lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 340 4900463
Fax
Email
nazimatariq96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available