Effects of Vestibular Rehabilitation on Balance and Post Stroke Fatigue :

November 4, 2024 updated by: Riphah International University

Effects of Vestibular Rehabilitation on Balance and Post Stroke Fatigue: a Randomized Control Trial

The objective of the study is to determine the effects of stroke conventional therapy compared with the effects of vestibular rehabilitation therapy on balance and post stroke fatigue. The study will be randomized control trial including 2 experimental groups with estimated 28 individual in each group

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is the sudden onset of neurological disorders caused by damage to the cerebrovascular arteries. Vascular injury to the brain can be caused by rapid changes in blood pressure and oxygen shortage, resulting in the death of brain cells. Ischemia accounts for 80% of all strokes. Every year, 15 million individuals worldwide suffer from strokes, and five million become permanently disabled. Stroke prevalence is 1.2% in the province of KPK. Over the last 30 years, the burden caused by stroke has significantly increased, and it has become one of the most common causes of mortality globally. . The central nervous system's sensory (visual, vestibular, somatosensory) and motor systems work together to maintain balance. Patients who have had a stroke are more likely to fall than healthy people due to a variety of impairments in motor and cognitive processes. Vestibular dysfunction may potentially cause falls in this patient population due to poor postural control. It has been found that post stroke patients are more prone than healthy controls to lose standing postural stability under vestibular stimulation. Fatigue is a common post stroke consequence, with a prevalence of between 16 to 74% , and it is considered one of the signs of post stroke depression. However, the fact that patients without depression often complain of fatigue needs a study of "post stroke fatigue" (PSF) as a specific syndrome. This type of fatigue is chronic which can be the only symptom in stroke patients even with adequate neurologic recovery and persists for many years .Fatigue constitutes one of the most common symptoms after a stroke and an important predictor for mortality following stroke. PSF correlates with functional limitations and participation limitations in activities of daily living (ADL), leading to a lower quality of life. Vestibular functions requiring central integration correlate more strongly with fatigue, balance, and walking capacity. Stroke patients have shown an improvement in gait performance, balance, and self-perceived health with vestibular rehabilitation. It has been demonstrated that vestibular therapy has greater benefits on gait in stroke patients. Vestibular rehabilitation therapy (VRT) promote gaze stability, improve postural stability and facilitate sensory integration for patients. VRT was found to be beneficial for improving balance in patients with peripheral vestibular impairment. Cawthorne and Cooksey Exercise Program refers to Vestibular Rehabilitation Therapy. They are exercises that gradually train the eye and body muscles to use visual and proprioceptive signals to compensate for missing or disturbed vestibular signals (which cause poor balance and coordination).Gaze stabilization exercises (GSEs), a type of vestibular therapy, including substitution and adaptation exercises that use the vestibulo-ocular reflex (VOR). Substitution exercises are designed to promote different approaches (saccadic eye movement and smooth tracking activities) to compensate for inadequate vestibular function. Adaptation exercises are long-term alterations in the neural response to head motions that aim to reduce symptoms and normalize gaze and postural stability. GSEs can improve the balance function, confidence, and cognition in older adults with mild cognitive dysfunction .VOR gain has a certain effect on the balance and posture of people following stroke. Balance is common consequence among post stroke patients and increase the risk of fall. The central nervous system's sensory (visual, vestibular, somatosensory) and motor systems work together to maintain balance and prevalence of post stroke fatigue is between 16 to 74% which is high and also the Vestibular functions having highly significant relation with fatigue, and balance and limited evidence on vestibular rehabilitation on post stroke fatigue. That's why this study aims to assess the effect of vestibular rehabilitation training on balance and post-stroke fatigue

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhuwa
      • Mānsehra, Khyber Pakhtunkhuwa, Pakistan, 2500
        • Recruiting
        • Helping Hand Institute of Rehabilitation
        • Contact:
        • Principal Investigator:
          • Zil-e- huma, MS-NMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient diagnosed with stroke.
  • Ability to stand for at least 1 minute without support.
  • Fatigue Assessment Scale (FAS) score ≥ 24.
  • Willingness to participate

Exclusion Criteria :

  • Cognitive Impairment.
  • Severe unilateral spatial neglect.
  • Severe aphasia.
  • Patients who are not willing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vestibular Rehabiliation Therapy
VRT include head and body movemnt, eye movement, balance training
Other: Vestibular Rehabiliation Therapy

Moving the eye horizontally between two stationary target while keeping the head still Moving the eye vertically between two stationary target while keeping the head still Moving the target horizontally and tracking it with the eye while keeping the head still Moving the target vertically and tracking it with the eye while keeping the head still Moving the head horizontally while a keeping a look on stationary target Moving the head vertically while a keeping a look on stationary target Moving the head and target in opposite direction horizontally while tracking the target with eyes Moving the head and target in opposite direction vertically while tracking the target with eyes.

Sit down and stand up, sit down and stand up with eye open and eye close Stand up, but turn to the right while standing Stand up, but turn to the left while standing Place an object on the floor. Take it and bring it above your head and place it on the floor again
Active Comparator: Conventional Treatment
conventional treatment include balance, walking, weight shifting and muscle strengthening training
Other: Conventional treatment
Standing balance training, weight shifting training, walking training, muscle strength training, step-up-and-down training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1. Berg Balance Scale
Time Frame: 8 weeks
changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
8 weeks
Fatigue Assessment Scale
Time Frame: 8 weeks
The FAS questionnaire was used to assess fatigue symptoms. This self-report questionnaire includes 10 items based on Likert's 5-point scale (1 = never, 5 = often). FAS scores vary from 10 to 50, with higher scores indicating increased fatigue. Fatigue in stroke patients was set at 24 based on the FAS. Total score range from 10 to 50. less than 22 indicates normal, 22 to 34 indicate mild to moderate fatigue,35 or more indicate severe fatigue.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nadia Azhar MS-NMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Zil-e-huma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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