Effects of Visual Scanning Exercises on Balance, Gait and Activities of Daily Livings in Patients with Post Stroke Eye Movement Disorders; A Randomized Controlled Trial
To compare the effects of visual scanning exercises on balance, gait and activities of daily livings in patients with post stroke eye movement disorders.
Out patient department of Physical Therapy Department, University of Lahore Teaching Hospital, Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients who suffered with eye-movement disorder either an ischemic or hemorrhagic stroke
• Clinically diagnosed by a neurologist
• Information on the type of stroke will be obtained from the patients’ medical records
• Both male and female patients between the age group of 19–60 years
• Minimum score of 7 on Mini-Mental State Examination
• Patients in the sub-acute stage after the stroke and able to follow instructions and have the capacity to
provide informed consent
Exclusion Criteria:
• Repeated stroke
• Severe dementia, identified by applying the MMSE
• History of an organic disorder or major psychiatric impairment
• Disability or other comorbid disease such as cancer or amputation that will limit or prevent
assessment of the patients
• Participation in other interventional or pharmacological studies which can affect the results of this
study
• Patients with vestibular problems who have positive dix-hallpike test
• Patients with facial palsy
• Patients with ophthalmological problems before stroke onset
• Patients suffering from balance problems as a result of muscular problem
Intervention groups
The patients will be randomly divided into experimental and control group. 32 patients in each group. Experimental group will receive visual scanning exercises along with task-specific approach while control group will receive task-specific approach alone.
Main outcome variables
1. Berg Balance Scale
2. The Dynamic Gait Index
3. Barthel index scale
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20190717044237N1
Registration date:2019-11-10, 1398/08/19
Registration timing:prospective
Last update:2019-11-10, 1398/08/19
Update count:1
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Sana Batool
Name of organization / entity
University of Lahore, Main campus
Country
Pakistan
Phone
+92 42 99200600
Email address
sana.batool1@uipt.uol.edu.pk
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-01-10, 2018/10/20
Expected recruitment end date
2641-06-10, 2020/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Visual Scanning Exercises on Balance, Gait and Activities of Daily Livings in Patients with Post Stroke Eye Movement Disorders; A Randomized Controlled Trial
Public title
Effects of Visual Scanning Exercises on Balance, Gait and Activities of Daily Livings in Patients with Post Stroke Eye Movement Disorders; A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who suffered with eye-movement disorder either an ischemic or hemorrhagic stroke
Clinically diagnosed by a neurologist
Information on the type of stroke will be obtained from the patients’ medical records
Both male and female patients between the age group of 19–60 years
Minimum score of 7 on Mini-Mental State Examination (MMSE)
Patients in the sub-acute stage after the stroke and able to follow instructions and have the capacity to provide informed consent
Exclusion criteria:
Repeated stroke
Severe dementia, identified by applying the MMSE
History of an organic disorder or major psychiatric impairment
Disability or other comorbid disease such as cancer or amputation that will limit or prevent assessment of the patients
Participation in other interventional or pharmacological studies which can affect the results of this study
Patients with vestibular problems who have positive dix-hallpike test
Patients with facial palsy • Patients with ophthalmological problems before stroke onset
Patients suffering from balance problems as a result of muscular problem
Age
From 19 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
A double-blind, randomized controlled design will be used. Assessors and patients will be blinded in the present study. They will not know about the group allocation and treatment allocation given to patients. All patients will be allocated randomly into experimental and control groups by using computer-generated random number table. All random numbers will be kept in a sealed envelope. All envelops will be kept by a third person who will not be involved in this study. For each patient a sealed envelope will be opened and mentioned group will be allocated.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and outcome assessors will be blinded in this study. Patients will not know about the treatment and group allocation and it will be achieved by random numbers. Random numbers will be kept in a sealed envelope. For each patient a sealed envelope will be opened and mentioned group will be allocated. Outcome assessors will just assess the outcomes of treatment at baseline and after four weeks in outcome measure questionnaires. They will not know that they are recording the outcome of which group so in this way they can not be biased.
Placebo
Not used
Assignment
Other
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Postal code
54000
Approval date
2639-12-11, 2018/09/20
Ethics committee reference number
IRB-UOL-FAHS/373-III/2018
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
164
ICD-10 code description
I64 Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Berg balance scale
Timepoint
Before intervention and at 4 weeks of intervention
Method of measurement
Scoring
Secondary outcomes
1
Description
Dynamic gait index scale to assess the gait impairments and risk of fall
Timepoint
Before and after 4 weeks of intervention
Method of measurement
A four -point ordinal scale ranging from 0-3 will be used
2
Description
Barthel index scale to measure the activities of daily living functions
Timepoint
Before and after 4 weeks of intervention
Method of measurement
A three -point ordinal scale ranging from 0-2 will be used
Intervention groups
1
Description
Intervention group: Intervention group will receive visual scanning exercises along with task-specific approach
Category
Treatment - Other
2
Description
Control group: Control group will receive task-specific approach which is used as routine physiotherapy. Task specific activities will be given in following steps. Step 1: In step 1 the physiotherapist will identify the missing components of movement by asking the patient to perform task. Step II: In step II the physiotherapist advice the patient to practice those missing components which were identified in step I. Step III: In step III the physiotherapist will advise the patient to practice the task as a whole. Step IV: In step IV the task is practiced in different environments i.e engage patients in practicing the functional tasks according to the level of balance and gait functions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
OPD of Physical Therapy Department, University of Lahore Teaching Hospital (ULTH), Lahore
Full name of responsible person
Dr. Sana Batool
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 99200600
Email
sana.fizza@gmail.com
Web page address
https://www.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore, main campus
Full name of responsible person
Dr. Sana Batool, PT
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 99200600
Email
sana.batool1@uipt.edu.pk
Web page address
https://www.uol.edu.pk
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore, main campus
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
University of Lahore
Full name of responsible person
Dr. Sana Batool, PT
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Neurological Physical therapy
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Province
Pakistan
Postal code
54000
Phone
+92 42 99200600
Email
sana.batool1@uipt.edu.pk
Web page address
https://www.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Sana Batool, PT
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Neurological Physical therapy
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 99200600
Email
sana.batool1@uipt.edu.pk
Web page address
https://www.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore, main campus
Full name of responsible person
Dr. Sana Batool, PT
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Neurological Physical therapy
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 99200600
Email
sana.batool1@uipt.edu.pk
Web page address
https://www.uol.edu.pk
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 collected deidentified IPD
When the data will become available and for how long
Data will be available to other people after the completion of study and remained available till 6 months
To whom data/document is available
Data will be available to people working in academic institutions
Under which criteria data/document could be used
Data can be accessed by communicating with principle investigator "Sana Batool" through institutional email address: sana.batool1@uipt.uol.edu.pk
From where data/document is obtainable
Data/document is available from principle investigator "Sana Batool" through institutional email address: sana.batool1@uipt.uol.edu.pk
What processes are involved for a request to access data/document
Data/document can be accessed through communicating with principle investigator "Sana Batool" on institutional email address: sana.batool1@uipt.uol.edu.pk