StrokeNCT05139537
Association of Vestibular and Postural Impairments With Functional Status in Stroke
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
: Stroke is leading cause of long-term disability in individuals. The location and extent of brain injury determines the severity of neurological deficits. The incidence of stroke dramatically increases in old age. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Stroke
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2021to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Age 35-70
- Male and female equal ratio
- Mine-mental state examination (MMSE) more than 25
- Confirmed ischemic stroke referred by neurologist using computerized tomography(CT)
- Patient after 6 months of 1st ischemic stroke
- Hypertensive patient
Who cannot join
- Unstable cardiovascular status
- Musculoskeletal conditions that influence posture e.g implants , orthodesis , fixation
- Unable to follow verbal commands
- Unable to keep any(sitting and standing) positions for 30 seconds.
- Diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Pakistan(Punjab_, 54000
About this study
: Stroke is leading cause of long-term disability in individuals. The location and extent of brain injury determines the severity of neurological deficits. The incidence of stroke dramatically increases in old age. Patients with stroke always come across with problems associated with balance, vertigo, dizziness and posture resulting in compromised activities of daily life. This study is aimed to collect data regarding the functional status of patients due to vestibular and postural impairments with stroke. The study will be descriptive comparative cross-sectional. It will be conducted at Idress Hospital Sialkot. This study will be completed within the time duration of six months. Convenient sampling techniques will be used to collect the data. Both genders with equal ratio will be included in this study after fulfillments of inclusion and exclusion criteria. Visual vertigo analogue scale, Dix-Hallpike Maneuver, DHI (Dizziness Handicap Inventory), Posture assessment scale for stroke (PASS) score, Time up and go test will be used as data collection tools. All data will be collected after informed consent from patient. All data will be collected under complete supervision of physiotherapist. All the data will be demonstrated as mean and percentage. The analysis of data will be done by using SPSS.26(Statistical Package For social science) and Excel. Statistical significance will be set as P = 0.05. Frequency tables, pie charts, bar charts will be used to show summary of group measurements measured over time. Our analysis will provide the association of vestibular and postural impairments with functional status in both males and females after stroke
Read the detailed description
Stroke (cerebrovascular accident CVA) is a medical condition associated with neurological deficits caused by interruption of blood flow to brain. Main types of strokes are ischemic (due to blood loss) and hemorrhagic (due to bleeding). Sign and symptoms of stroke may include inability to move or feel, problem understanding and speaking, dizziness, unable to walk and dependency in daily life. All these factors effect the functionality of the patient. If symptoms last less than one or two hours then it is transient ischemic stroke (TIA), also known as mini stroke. Modifiable risk factors associated with stroke are high blood pressure, smoking, diabetes, metabolic diseases and obesity. Male gender , ethnicity, family history , genetic predisposition and old age all are non-modifiable risk factors.
Vestibular dysfunction is define as the disturbance in body's balance system. It may be due to peripheral or central disorders. The peripheral cause for vestibular dysfunction is peripheral neuritis. The most common cause of the central vestibular dysfunction is an ischemic stroke of posterior fossa which contains brain stem and cerebellum. Vestibular dysfunction often present as dizziness. patients with vestibular dysfunction are at high risk of fall due to vertigo and gait imbalances, postural instability, increased sway and irregulated gate Risk factors associated with vestibular dysfunctions include female gender, age more than 40 years, depression and poor educational status.
The balance impairments in post stroke state is complex. It includes weight bearing asymmetry, muscles weakness, increased visual dependency and disturbed perceptions. All these factors effect the independent functionality of the patient. Postural instability increases after stroke which result in restriction in independence of daily activities.
There is relation between dizziness and stoke. Patients with dizziness or vertigo are at higher risk of stroke than general population. Dizziness is common in patients who experience stroke for the first time. Dizziness is a cognitive manifestation of disturbed balance system of body. Dizziness is a risk factor for fall and it has negative influence on quality of life.
Balance is defined as the ability to maintain the center of gravity within base of support with minimal postural sway. Balance is classified as static and dynamic balance. Static balance is associated with sitting and standing, while dynamic balance is associated with walking and running. Insufficient balance in stroke survivors due to sensory and motor deficits results in decrease activities of daily life and functional status.
Patients suffering from posterior inferior cerebral artery PICA stroke, present with vertigo, dizziness, vomiting, headache, gait changes, impairments in postural control and horizontal nystagmus ipsilateral to the lesion. These symptoms are result of a compromised vestibular afferent sensory input which impairs the motor output for the management/maintenance of balance.
The aim of this study is to find the association between vestibular and postural impairment on functional status of patients .Our study will also provide the difference of result between male and females whether they are equally effected or not.
- Conditions
- Stroke
- Keywords
- vestibular impairments, functional status.
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Vertigo Analogue Scale
This scale indicates the amount of dzziness patient experince by covering distance of 10cm in different environments scoring 0-10.(43) The VVAS shows high validity and responsiveness to any change detected clinically. The VVAS can also be used to verify the progression of the client's symptoms.
Measured: Baseline (single reading)
Dix Hallpike Maneuver
When performing the Dix-Hallpike test, patients are lowered quickly to a supine position (lying horizontally with the face and torso facing up) with the neck extended 30 degrees below horizontal by the clinician performing the maneuver
Measured: Baseline (single reading)
Diszziness Handicap Inventory
The DHI is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap.
Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0
Measured: Baseline (single reading)
.Posture assessment scale for stroke (PASS) score:
it consist of 12 items which are assessed on 4 levels (0-3 points) on rating scale. It assesses the eligibility to maintain or change lying, sitting and standing posture.(46) This scale is easy to use and has good interrater and intra-rater reliability as well as internal consistency
Measured: Baseline (single reading)
Time up and go test
- 10 seconds = normal ≤20 second = good mobility can go out alone, mobile without gait aid
- 30 seconds = problems, cannot go outside alone, requires gait aid A score of ≥ 14 seconds has been shown to indicate high risk of falls
Measured: Baseline (single reading)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Jan 2021
- Primary completion20 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139537
- Sponsor's protocol ID
- RiphahIU Maryam Bashir
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Vestibular and Postural Impairments With Functional Status in Stroke
- ClinicalTrials.gov ID
- NCT05139537
- Acronym / sponsor ID
- RiphahIU Maryam Bashir
- Conditions
- Stroke
- Keywords
- vestibular impairments, functional status.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: Stroke is leading cause of long-term disability in individuals. The location and extent of brain injury determines the severity of neurological deficits. The incidence of stroke dramatically increases in old age. Patients with stroke always come across with problems associated with balance, vertigo, dizziness and posture resulting in compromised activities of daily life. This study is aimed to collect data regarding the functional status of patients due to vestibular and postural impairments with stroke. The study will be descriptive comparative cross-sectional. It will be conducted at Idress Hospital Sialkot. This study will be completed within the time duration of six months. Convenient sampling techniques will be used to collect the data. Both genders with equal ratio will be included in this study after fulfillments of inclusion and exclusion criteria. Visual vertigo analogue scale, Dix-Hallpike Maneuver, DHI (Dizziness Handicap Inventory), Posture assessment scale for stroke (PASS) score, Time up and go test will be used as data collection tools. All data will be collected after informed consent from patient. All data will be collected under complete supervision of physiotherapist. All the data will be demonstrated as mean and percentage. The analysis of data will be done by using SPSS.26(Statistical Package For social science) and Excel. Statistical significance will be set as P = 0.05. Frequency tables, pie charts, bar charts will be used to show summary of group measurements measured over time. Our analysis will provide the association of vestibular and postural impairments with functional status in both males and females after stroke
Detailed description
Stroke (cerebrovascular accident CVA) is a medical condition associated with neurological deficits caused by interruption of blood flow to brain. Main types of strokes are ischemic (due to blood loss) and hemorrhagic (due to bleeding). Sign and symptoms of stroke may include inability to move or feel, problem understanding and speaking, dizziness, unable to walk and dependency in daily life. All these factors effect the functionality of the patient. If symptoms last less than one or two hours then it is transient ischemic stroke (TIA), also known as mini stroke. Modifiable risk factors associated with stroke are high blood pressure, smoking, diabetes, metabolic diseases and obesity. Male gender , ethnicity, family history , genetic predisposition and old age all are non-modifiable risk factors.
Vestibular dysfunction is define as the disturbance in body's balance system. It may be due to peripheral or central disorders. The peripheral cause for vestibular dysfunction is peripheral neuritis. The most common cause of the central vestibular dysfunction is an ischemic stroke of posterior fossa which contains brain stem and cerebellum. Vestibular dysfunction often present as dizziness. patients with vestibular dysfunction are at high risk of fall due to vertigo and gait imbalances, postural instability, increased sway and irregulated gate Risk factors associated with vestibular dysfunctions include female gender, age more than 40 years, depression and poor educational status.
The balance impairments in post stroke state is complex. It includes weight bearing asymmetry, muscles weakness, increased visual dependency and disturbed perceptions. All these factors effect the independent functionality of the patient. Postural instability increases after stroke which result in restriction in independence of daily activities.
There is relation between dizziness and stoke. Patients with dizziness or vertigo are at higher risk of stroke than general population. Dizziness is common in patients who experience stroke for the first time. Dizziness is a cognitive manifestation of disturbed balance system of body. Dizziness is a risk factor for fall and it has negative influence on quality of life.
Balance is defined as the ability to maintain the center of gravity within base of support with minimal postural sway. Balance is classified as static and dynamic balance. Static balance is associated with sitting and standing, while dynamic balance is associated with walking and running. Insufficient balance in stroke survivors due to sensory and motor deficits results in decrease activities of daily life and functional status.
Patients suffering from posterior inferior cerebral artery PICA stroke, present with vertigo, dizziness, vomiting, headache, gait changes, impairments in postural control and horizontal nystagmus ipsilateral to the lesion. These symptoms are result of a compromised vestibular afferent sensory input which impairs the motor output for the management/maintenance of balance.
The aim of this study is to find the association between vestibular and postural impairment on functional status of patients .Our study will also provide the difference of result between male and females whether they are equally effected or not.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (6 listed)
- Age 35-70
- Male and female equal ratio
- Mine-mental state examination (MMSE) more than 25
- Confirmed ischemic stroke referred by neurologist using computerized tomography(CT)
- Patient after 6 months of 1st ischemic stroke
Key exclusion criteria (5 listed)
- Unstable cardiovascular status
- Musculoskeletal conditions that influence posture e.g implants , orthodesis , fixation
- Unable to follow verbal commands
- Unable to keep any(sitting and standing) positions for 30 seconds.
- Diabetic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Vertigo Analogue Scale
Time frame: Baseline (single reading)
This scale indicates the amount of dzziness patient experince by covering distance of 10cm in different environments scoring 0-10.(43) The VVAS shows high validity and responsiveness to any change detected clinically. The VVAS can also be used to verify the progression of the client's symptoms.
Dix Hallpike Maneuver
Time frame: Baseline (single reading)
When performing the Dix-Hallpike test, patients are lowered quickly to a supine position (lying horizontally with the face and torso facing up) with the neck extended 30 degrees below horizontal by the clinician performing the maneuver
Diszziness Handicap Inventory
Time frame: Baseline (single reading)
The DHI is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0
.Posture assessment scale for stroke (PASS) score:
Time frame: Baseline (single reading)
it consist of 12 items which are assessed on 4 levels (0-3 points) on rating scale. It assesses the eligibility to maintain or change lying, sitting and standing posture.(46) This scale is easy to use and has good interrater and intra-rater reliability as well as internal consistency
Time up and go test
Time frame: Baseline (single reading)
* 10 seconds = normal ≤20 second = good mobility can go out alone, mobile without gait aid * 30 seconds = problems, cannot go outside alone, requires gait aid A score of ≥ 14 seconds has been shown to indicate high risk of falls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehreem Mukhtar, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Vertigo Analogue Scale (time frame: Baseline (single reading)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.