Protocol summary
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Study aim
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To compare the effects of visual scanning exercises on balance, gait and activities of daily livings in patients with post stroke eye movement disorders.
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Design
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Double blinded Randomized controlled clinical trial
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Settings and conduct
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Out patient department of Physical Therapy Department, University of Lahore Teaching Hospital, Lahore
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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1. Berg Balance Scale
2. The Dynamic Gait Index
3. Barthel index scale
General information
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Reason for update
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I want to mention actual recruitment start and end date of my data collection. Also I want to mention trial completion date.
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20190717044237N1
Registration date:
2019-11-10, 1398/08/19
Registration timing:
registered_while_recruiting
Last update:
2022-05-14, 1401/02/24
Update count:
1
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Registration date
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2019-11-10, 1398/08/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-20, 1397/07/28
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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2019-05-01, 1398/02/11
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Actual recruitment end date
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2020-10-01, 1399/07/10
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Trial completion date
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2020-11-01, 1399/08/11
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 19 years old to 60 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
64
Actual sample size reached:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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No
Ethics committees
1
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Ethics committee
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Approval date
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2018-09-20, 1397/06/29
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Ethics committee reference number
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IRB-UOL-FAHS/373-V/2018
Health conditions studied
1
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Description of health condition studied
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Stroke
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ICD-10 code
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164
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ICD-10 code description
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I64 Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
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Description
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Berg balance scale
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Timepoint
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Before intervention and at 4 weeks of intervention
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Method of measurement
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Scoring
Secondary outcomes
1
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Description
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Dynamic gait index scale to assess the gait impairments and risk of fall
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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A four -point ordinal scale ranging from 0-3 will be used
2
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Description
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Barthel index scale to measure the activities of daily living functions
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Timepoint
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Before and after 4 weeks of intervention
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Method of measurement
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A three -point ordinal scale ranging from 0-2 will be used
Intervention groups
1
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Description
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Intervention group: Intervention group will receive visual scanning exercises along with task-specific approach
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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N/A
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Grant code / Reference number
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N/A
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of Lahore, main campus
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected deidentified IPD
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When the data will become available and for how long
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Data will be available to other people after the completion of study and remained available till 6 months
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To whom data/document is available
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Data will be available to people working in academic institutions
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Under which criteria data/document could be used
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Data can be accessed by communicating with principle investigator "Sana Batool" through institutional email address: sana.batool1@uipt.uol.edu.pk
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From where data/document is obtainable
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Data/document is available from principle investigator "Sana Batool" through institutional email address: sana.batool1@uipt.uol.edu.pk
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What processes are involved for a request to access data/document
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Data/document can be accessed through communicating with principle investigator "Sana Batool" on institutional email address: sana.batool1@uipt.uol.edu.pk
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Comments
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N/A