Benign Paroxysmal VertigoNCT05166473
Effectiveness of Telerehabilitation Exercise for Bening Paroxysmal Positional Vertigo
A study testing Telerehabilitation group (n=21) in people with Benign Paroxysmal Vertigo, run by Alanya Alaaddin Keykubat University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign Paroxysmal Vertigo
- What is being tested?
- Telerehabilitation group (n=21)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 May 2021to 30 Jan 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Alanya Alaaddin Keykubat Üniversity
Antalya, Alanya, 07450
Alanyaaku
Antalya, Alanya
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Paroxysmal Vertigo
- Being tested
- Telerehabilitation group (n=21), Control Group (n=21)
- Keywords
- Bening paroxysmal vertigo, telerehabilitation, physiotherapy, halpike maneuver, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation group (n=21)Other
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.
Control Group (n=21)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group (n=21) | Experimental | 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. Receives: Other: Telerehabilitation group (n=21) |
| Control Group (n=21) | Active comparator | 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. Receives: Other: Control Group (n=21) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "baseline" and "immediately after the intervention"
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.
Measured: "baseline,preintervention " and "immediately after the intervention"
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.
Measured: "baseline" and "immediately after the intervention"
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).
Measured: "baseline" and "immediately after the intervention"
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.
Measured: "baseline" and "immediately after the intervention"
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.
Measured: "baseline" and "immediately after the intervention"
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.
Measured: "baseline" and "immediately after the intervention"
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.
Measured: "baseline" and "immediately after the intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start10 May 2021
- Primary completion30 Nov 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal VertigoStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166473
- Sponsor's protocol ID
- 10354421-2021/07-09
- Status last verified
- Jul 2022
- First submitted
- 7 Sep 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Telerehabilitation Exercise Practices Effective In Patients Diagnosed With Beign Paroxysmal Positional Vertigo?
- ClinicalTrials.gov ID
- NCT05166473
- Acronym / sponsor ID
- 10354421-2021/07-09
- Conditions
- Benign Paroxysmal Vertigo
- Keywords
- Bening paroxysmal vertigo, telerehabilitation, physiotherapy, halpike maneuver, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 22 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group (n=21) | Experimental | 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. |
| Control Group (n=21) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| 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) |
Primary outcome
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.
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.
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.
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).
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.
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.
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.
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.
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 12 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation group (n=21) in people with Benign Paroxysmal Vertigo, run by Alanya Alaaddin Keykubat University at 2 sites in Turkey (Türkiye).
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 7 inclusion and 11 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Change in Tandem test (time frame: "baseline" and "immediately after the intervention"). The study lists 8 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 12 Jul 2022.