NCT05139537

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 8, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

vestibular impairments, functional status.

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

    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

    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

    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

    Baseline (single reading)

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Pakistan(Punjab_, 54000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tehreem Mukhtar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 1, 2021

Study Start

January 15, 2021

Primary Completion

July 20, 2021

Study Completion

August 30, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations