search
Back to results

Effectiveness of Telerehabilitation Exercise for Bening Paroxysmal Positional Vertigo

Primary Purpose

Benign Paroxysmal Vertigo

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation group (n=21)
Control Group (n=21)
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Vertigo focused on measuring Bening paroxysmal vertigo, telerehabilitation, physiotherapy, halpike maneuver, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alanya Alaaddin Keykubat Üniversity
  • Alanyaaku

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation group (n=21)

Control Group (n=21)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Tandem test
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.
Change in Semitandem test
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.
Change in Dizziness disability inventory (BEE) score:
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.
Change in Vertigo symptom scale
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).
Change in Beck anxiety scale
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.
Change in Vertigo Dizziness Imbalance Questionnaire
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.
Chang in Visual Analog Scale
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.
Change in Romberg test
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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
July 11, 2022
Sponsor
Alanya Alaaddin Keykubat University
search

1. Study Identification

Unique Protocol Identification Number
NCT05166473
Brief Title
Effectiveness of Telerehabilitation Exercise for Bening Paroxysmal Positional Vertigo
Official Title
Are Telerehabilitation Exercise Practices Effective In Patients Diagnosed With Beign Paroxysmal Positional Vertigo?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alanya Alaaddin Keykubat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Vertigo
Keywords
Bening paroxysmal vertigo, telerehabilitation, physiotherapy, halpike maneuver, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Participant
Masking Description
it was calculated that 80% power could be achieved in the 95% confidence December when at least 42 people (at least 21 people for each group) were taken into the study. In all tests, the statistical significance level was taken as p<0.05.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group (n=21)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (n=21)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation group (n=21)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group (n=21)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Tandem test
Description
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.
Time Frame
"baseline" and "immediately after the intervention"
Title
Change in Semitandem test
Description
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.
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
Change in Dizziness disability inventory (BEE) score:
Description
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.
Time Frame
"baseline" and "immediately after the intervention"
Title
Change in Vertigo symptom scale
Description
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).
Time Frame
"baseline" and "immediately after the intervention"
Title
Change in Beck anxiety scale
Description
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.
Time Frame
"baseline" and "immediately after the intervention"
Title
Change in Vertigo Dizziness Imbalance Questionnaire
Description
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.
Time Frame
"baseline" and "immediately after the intervention"
Title
Chang in Visual Analog Scale
Description
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.
Time Frame
"baseline" and "immediately after the intervention"
Title
Change in Romberg test
Description
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.
Time Frame
"baseline" and "immediately after the intervention"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alanya Alaaddin Keykubat Üniversity
City
Antalya
State/Province
Alanya
ZIP/Postal Code
07450
Country
Turkey
Facility Name
Alanyaaku
City
Antalya
State/Province
Alanya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Telerehabilitation Exercise for Bening Paroxysmal Positional Vertigo

We'll reach out to this number within 24 hrs