Effectiveness of Telerehabilitation Exercise for Bening Paroxysmal Positional Vertigo

July 11, 2022 updated by: Ayça Araci, Alanya Alaaddin Keykubat University

Are Telerehabilitation Exercise Practices Effective In Patients Diagnosed With Beign Paroxysmal Positional Vertigo?

In addition to the channelize reposition maneuvers (KRM) that will be applied by the physician in patients diagnosed with Benign paroxysmal positional Vertigo (BPPV), the aim of the study is to investigate the effect of vestibular rehabilitation exercises that will be October based on telerehabilitation by the physiotherapist.

Study Overview

Status

Status

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

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

Benign paroxysmal positional vertigo (BPPV), the most common form of recurrent vertigo the common cause. Short-term, occurring with specific head movements, it is described as episodic, transient vertigo attacks.Calcium in the movement of the head autocoids formed from carbonate crystals emerge from the places and one or more crystals enter the semicircular channel, which affects the endolymphatic flow of the Vertigo leads to the formation. BPPV is also characterized by positional nystagmus along side positional vertigo. BPPV often causes a person to restrict person's life and weeks or it recovers spontaneously within months. Autolytic debrides in the cupula aimed at separating the cupula or removing the clutches from the canal vestibular exercises or maneuvers significantly accelerate healing. In the treatment of BPPV, vestibular rehabilitation applications are used primarily.As a vestibular rehabilitation, the canalith reposition maneuver, developed by Epley and effective, is often preferred. Telerehabilitation, rehabilitation by the use of electronic communication systems describes the provision of services to patients remotely. Transport to health services to provide an effective rehabilitation service to patients when limited it takes advantage of telerehabilitation. Some studies show that telerehabilitation can reduce health care costs, improve physical and mental function and quality of life, and be presented in a way that satisfies patients.The Covid-19 epidemic outbreak has affected health care. To protect healthcare workers and patients from the risk of infection, to ensure widespread use of telecommunications technology instead of face-to-face clinical visits, rules, regulations.With these arrangements, telerehabilitation became of great importance for physiotherapists.High levels of evidence on image-based telerehabilitation technologies suggest that they can be used for remote diagnosis and patient follow-up and are the most effective method for physiotherapists. Pain of exercise through telerehabilitation compared to other interventions, it has at least similar effects on physical function and quality of life references. As a method of vestibular rehabilitation, mostly when examined in the literature it has been observed that manoeuvring has been applied and these practices have been compared with drugs. In this study, aim is to support the literature by adding exercise practices given according to the levels of telerehabilitation-based patients along with maneuver practices.

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 (Actual)

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.
42

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 Locations

  • Turkey
    • Alanya
      • Antalya, Alanya, Turkey
        • Alanyaaku
      • Antalya, Alanya, Turkey, 07450
        • Alanya Alaaddin Keykubat University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being diagnosed with positional vertigo,
  • Be in the December 18-65 age range
  • Dix Hallpike maneuver test ( + ),
  • Who volunteers to participate in the study
  • Sufficient to use technology,
  • Can understand the instructions given in Turkish
  • Having smart phone and active internet connection

Exclusion Criteria:

  • At the end of the examination, there are signs of acute or chronic infection
  • Thought to have neurological pathology that causes dizziness
  • Head trauma, with a history of surgical operation
  • Lower extremity pain that prevents you from standing and giving a load
  • A history or symptom of diseases of the vestibular system other than BPPV
  • Lower limb surgery

  • Sudden sensorial hearing loss and the presence of chronic otitis media

    • Pregnancy

  • Presence of a serious cognitive disorder detected by a doctor at a level that will prevent testing
  • Not being at a mental level to understand and answer survey questions
  • Cervical pathologies that can lead to dizziness

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: Single

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: Telerehabilitation group (n=21)
This group was conducted with a physiotherapist for video conference-based vestibular rehabilitation exercises, was called the "telerehabilitation group (TR)". In terms of ease of Use and applicability, the WhatsApp app was preferred. Patients were individually searched for two days a week, 25-30 minutes. The exercises were performed gradually from easy to difficult, initially in a sitting position in accordance with the levels of the patients.
Other: Telerehabilitation group (n=21)
This group was conducted with a physiotherapist for video conference-based vestibular rehabilitation exercises, was called the "telerehabilitation group (TR)". In terms of ease of Use and applicability, the WhatsApp app was preferred. Patients were individually searched for two days a week, 25-30 minutes. The exercises were performed gradually from easy to difficult, initially in a sitting position in accordance with the levels of the patients.
Active Comparator: Control Group (n=21)
After the home exercise program, which should be applied twice a day for six weeks, was shown in practice, the home exercise program was given, in which the exercises were visual and written, this group was called the "control group". All participants were given a phone number to consult when there were any problems, and were phoned to decry whether they were continuing the exercises.
Other: Control Group (n=21)
After the home exercise program, which should be applied twice a day for six weeks, was shown in practice, the home exercise program was given, in which the exercises were visual and written, this group was called the "control group". All participants were given a phone number to consult when there were any problems, and were phoned to decry whether they were continuing the exercises.

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
Change in Tandem test
Time Frame: "baseline" and "immediately after the intervention"
The patient positioned the heel of one foot so that it came to the tip of the finger of the other foot. He tried to maintain his position for 30 seconds with his hands outstretched and eyes open and closed in parallel. Duration recorded in sec.
"baseline" and "immediately after the intervention"
Change in Semitandem test
Time Frame: "baseline,preintervention " and "immediately after the intervention"
The patient positioned his feet so that one foot was slightly in front of and adjacent to the other. He tried to maintain his position for 30 seconds with his hands outstretched and eyes open and closed in parallel. The length of time it could stop was recorded in second.
"baseline,preintervention " and "immediately after the intervention"
Change in Dizziness disability inventory (BEE) score:
Time Frame: "baseline" and "immediately after the intervention"
It provides the determination of the factors that cause dizziness and balance disorder of patients experiencing dizziness and their physical, functional and sensory status in diseases of the vestibular system.The inventory consists of 25 questions. It contains 7 questions that study physical effects, 9 questions that study functional effect, and 9 questions that include emotional factors. The answers to the questions are given yes (4 points) , sometimes (2 points), no (0 points). The maximum score of the factors studying physical effects is 28, the maximum score of the factors studying sensory and functional effects is 36 points. A high score indicates that a person has high symptoms of dizziness, and dizziness is considered to cause restriction in their daily life activities.
"baseline" and "immediately after the intervention"
Change in Vertigo symptom scale
Time Frame: "baseline" and "immediately after the intervention"
Vertigo symptom scale is a scale designed to determine somatic anxiety and autonomic complaint in patients with dizziness complaints.It contains 8 articles related to vertigo (0-32 points), 7 articles containing autonomic complaints (0-28 points).
"baseline" and "immediately after the intervention"
Change in Beck anxiety scale
Time Frame: "baseline" and "immediately after the intervention"
The Beck Anxiety Scale was used to determine patients ' anxiety levels and frequency of symptoms.0 points: none, 1 point: light , 2 points: medium , 3 points: seriously determined. (8-15 points ) mild anxiety symptoms are defined as moderate (16-25 points), moderate (26-63 points), severe anxiety level.
"baseline" and "immediately after the intervention"
Change in Vertigo Dizziness Imbalance Questionnaire
Time Frame: "baseline" and "immediately after the intervention"
It is used to measure the frequency of vertigo and dizziness complaints in patients and to determine how much their quality of life is affected.It consists of 14 questions for symptoms and 22 questions for measuring the quality of life. In the survey, which contains a total of 36 questions, the questions are scored as 0: all the time, 1: most of the time, 2: often, 3: sometimes, 4: very infrequently and 5: never. The total score on the symptom scale is 70, and the quality of life is 100. The high score obtained indicates that the person has few symptoms and has a high quality of life.
"baseline" and "immediately after the intervention"
Chang in Visual Analog Scale
Time Frame: "baseline" and "immediately after the intervention"
The Visual Analog scale (VAS) has been used to determine the severity of dizziness. The patient is asked to score between 0 and 10.0: I don't have dizziness, 1-4: Mild severity, 4-8: Moderate severity, 10: I have unbearable dizziness.
"baseline" and "immediately after the intervention"
Change in Romberg test
Time Frame: "baseline" and "immediately after the intervention"
When the patients stand in a correct posture, postural control is provided by visual, somatosensory, vestibular system stimuli. In the Romberg test, the patient stood with the feet united. He joined his hands diagonally in front of the trunk. He tried to maintain his position for 30 seconds with his eyes closed. If there is a disorder of the vestibular system, the patient has a tendency to fall towards the side where the lesion is located.
"baseline" and "immediately after the intervention"

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.
Alanya Alaaddin Keykubat 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.
May 10, 2021

Primary Completion (Actual)

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.
November 30, 2021

Study Completion (Actual)

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.
January 30, 2022

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).
September 7, 2021

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.
December 21, 2021

First Posted (Actual)

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.
December 22, 2021

Study Record Updates

Last Update Posted (Actual)

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.
July 12, 2022

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.
July 11, 2022

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.
July 1, 2022

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.
  • 10354421-2021/07-09

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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