Comprehensive Evaluation in Patients With Meniere's Disease
NCT05844657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34
Last updated 2023-10-13
Summary
The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.
Conditions
- Meniere Disease
- Psychosocial Problem
- Physical Disability
- Quality of Life
Interventions
- OTHER
-
Case report form
Sociodemographic information (age, gender, height, body mass index, marital status, occupation, education level, contact information), frequency of smoking and alcohol use, frequency of caffeine consumption, frequency of salt consumption, dominant side, background, family history, medical and audiological information were recorded.
- OTHER
-
Tinnitus disability scale
Tinnitus disability scale was used to evaluate the tinnitus severity of Meniere's patients. It consists of 25 items in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Tinnitus level or severity is determined by calculating the total score of the answers given.
- OTHER
-
A feeling of fullness and/or pressure in the ear
The feeling of fullness or pressure in the ear was evaluated verbally by receiving yes/no responses from the participants.
- OTHER
-
Dizziness intensity and frequency
In order to determine the frequency and severity of dizziness, the participants were asked to mark the appropriate score between 1-10 points.
- OTHER
-
Dizziness disability inventory
The dizziness disability inventory was used to determine the disability level of the individuals participating in our study. It consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'.
- OTHER
-
Vertigo symptom scale-short form
The short form of the vertigo symptom scale was used to determine the frequency and duration of vertigo in the individuals participating in our study. The vertigo symptom scale consisting of 8 questions consists of vertigo (VSS-V), and the vertigo symptom scale consisting of 7 questions consists of two subsections consisting of a total of 15 questions: anxiety (VSS-A). Each item; Never (0), Very rarely (1 point), Often (2 points), Often - every week (3 points), Very often - On average, at least twice a week (4 points). The total score ranges from 0 to 60.
- OTHER
-
Hearing Impairment Scale
The Adult Hearing Impairment Scale was used to determine the effect of the current hearing impairment levels of the individuals participating in our study on their daily living activities. The scale consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Participants mark the most appropriate expression for them.
- OTHER
-
Cervical Range of Motion (CROM 3) device
"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception and range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
- OTHER
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Temporomandibular joint range of motion assessment
In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.
- OTHER
-
Posture evaluation with New York posture analysis
The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.
- OTHER
-
Evaluation of the anterior tilt angle of the head
Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.
- OTHER
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Evaluation of postural balance with the Freemed pressure platform
Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.
- OTHER
-
Static balance assessment with tandem stance test
In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.
- OTHER
-
Dynamic balance assessment with tandem gait test
In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.
- OTHER
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Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment
Headache, temporomandibular pain and craniocervical pain were asked to mark the person from the photographs taken from the front, back and side in the form of a human figure. Pain severity was evaluated with the numerical rating scale (NRS).
- OTHER
-
Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.
- OTHER
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International physical activity questionnaire-measurement of physical activity level with short
The short form of the international physical activity questionnaire was used to determine the physical activity level of the individuals participating in our study. The short form of the international physical activity questionnaire evaluates the last week and consists of a total of 4 sections and 7 questions. Duration of physical activity that requires intense physical effort, such as heavy lifting, soccer, or fast cycling; times of doing moderate physical activities that cause breathing slightly more often than usual; The total duration of walks at work, home, for sports, exercise and hobby, and the total sitting time spent in a day at work, at home or while resting are calculated.
- OTHER
-
Evaluation of sleep quality with the Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PUKI) was used to evaluate the sleep quality and disturbance of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant responds to each item according to the frequency between 0-3 points. The total score (0-21 points) from these components indicates whether the sleep quality is good or not.
- OTHER
-
Evaluation of fatigue with the fatigue severity scale
The Fatigue severity scale was used to evaluate the fatigue status of the individuals participating in our study. The scale uses a scoring system ranging from 1-7, which starts as I do not agree (1 point) and increases gradually towards I agree (7 point). It consists of 9 items in total and people mark the option that suits them.
- OTHER
-
Evaluation of anxiety-depression status with hospital anxiety and depression scale
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the anxiety and depression status of the individuals participating in our study. For each item, the participant answers with a four-point (0-3 points) response option. Therefore, the possible score probabilities in line with the answers given are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, while the cut-off point for the depression subscale is 7 points.
- OTHER
-
Evaluation of quality of life with short form-12 (SF-12)
The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.
- OTHER
-
the International Fall Efficiency Scale
The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 (no worries) to 64 (extremely worried).
- OTHER
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assessment of muscle performance
In our study, the strength of cervical flexors, anterior and oblique trunk flexors, cervical extensor muscles, back extensor muscles, trapezius muscle, and rhomboid major-minor muscles were evaluated. In addition, the endurance of the deep cervical flexor muscles, cervical flexors and cervical extensor muscles were also evaluated.
Sponsors & Collaborators
-
Hacettepe University
lead OTHER
Principal Investigators
-
Nezire Kose · Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-15
- Primary Completion
- 2023-09-04
- Completion
- 2023-10-04
Countries
- Turkey (Türkiye)
Study Locations
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