- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05166473
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
42
Phase
- 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
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Alanya
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Antalya, Alanya, Turkey
- Alanyaaku
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Antalya, Alanya, Turkey, 07450
- Alanya Alaaddin Keykubat University
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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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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"
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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"
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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).
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"baseline" and "immediately after the intervention"
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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.
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"baseline" and "immediately after the intervention"
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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.
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"baseline" and "immediately after the intervention"
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Chang in Visual Analog Scale
Time Frame: "baseline" and "immediately after the intervention"
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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.
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"baseline" and "immediately after the intervention"
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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.
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"baseline" and "immediately after the intervention"
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 10, 2021
Primary Completion (Actual)
November 30, 2021
Study Completion (Actual)
January 30, 2022
Study Registration Dates
First Submitted
September 7, 2021
First Submitted That Met QC Criteria
December 21, 2021
First Posted (Actual)
December 22, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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