Trial · NCT05021939
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gait Speed- Without Head Turns | 8 week | The gait speed will be measured using a 10-meter walking test (10MWT). A conventional 10-meter walk course with acceleration and deceleration zones at each end was used to test self-selected walking speed. Individuals in the 10 MWT walk (at a preferred pace) for 10 meters without assistance, with the intermediate 6 meters being timed to allow for acceleration and deceleration. The timing is started when the patient first crosses the 2-meter mark and the timing is stoped when the patient completely passes the 8-meter mark, which allows for 2 meters of acceleration at the start and 2 meters of deceleration at the end of the course. This test will be applied without head turning. A total of 3 trial will be made and the average is recorded in meters per second (m/s). |
| Primary | Gait Speed- With Horizontal Head Turns | 8 week | The gait speed with horizontal head turns will be measured using a 10-meter walking test (10MWT). A conventional 10-meter walk course with acceleration and deceleration zones at each end was used to test self-selected walking speed. Individuals in the 10 MWT walk (at a preferred pace) for 10 meters without assistance, with the intermediate 6 meters being timed to allow for acceleration and deceleration. The timing is started when the patient first crosses the 2-meter mark and the timing is stoped when the patient completely passes the 8-meter mark, which allows for 2 meters of acceleration at the start and 2 meters of deceleration at the end of the course. The participant will be requested to walk in a pre-measured 10 meter area while performing head turns at approximately 30 degrees towards right and left. A total of 3 trial will be made and the average is recorded in meters per second (m/s). |
| Primary | Gait Speed- With Vertical Head Turns | 8 week | The gait speed with vertical head turns will be measured using a 10-meter walking test (10MWT). A conventional 10-meter walk course with acceleration and deceleration zones at each end was used to test self-selected walking speed. Individuals in the 10 MWT walk (at a preferred pace) for 10 meters without assistance, with the intermediate 6 meters being timed to allow for acceleration and deceleration. The timing is started when the patient first crosses the 2-meter mark and the timing is stoped when the patient completely passes the 8-meter mark, which allows for 2 meters of acceleration at the start and 2 meters of deceleration at the end of the course. The participant will be requested to walk in a pre-measured 10 meter area while performing head turns at approximately 45 degrees towards up and down. A total of 3 trial will be made and the average is recorded in meters per second (m/s). |
| Secondary | Dix Hallpike (Posterior Semicircular Canal Test) | 8 weeks | The roll test can determine whether the posterior semicircular canal is involved. The patient begins in long-sitting position. Frenzel glasses will be used to visualize the nistagmus during the procedure. The patient will be instructed to rotate his/her head 45 degrees toward the direction of the involed side. With the assistance of the clinician the patient will be quickly bring to lying position with their neck is extended about 45 degrees. Frenzel glasses will be used to visualize the nistagmus for aproximately 60 seconds during the procedure. |
| Secondary | Roll Test (Lateral Semicircular Canal Test) | 8 weeks | The roll test can determine whether the lateral semicircular canal is involved. The roll test requires the person to be in a supine position with their head in 30 degrees of neck flexion. Then the clinician will quickly rotate the head 90 degrees to the left side, and checks for vertigo and nystagmus. Frenzel glasses will be used to visualize the nistagmus for aproximately 60 seconds during the procedure. |
| Secondary | Choice Stepping Reaction Time Test | 8 week | A custom-made Choice Stepping Reaction Time step pad (CSRT-MAT) and a computer unit will be used to evaluate the processing speed. The system is consisted of a CSRT-MAT having pressure-sensitive panels and a display monitor connected to a computer unit. The computer unit recorded the timing of foot lifting and landing. The step direction is indicated by one arrow changing its color. The CSRT device included 2 tests: Stepping Reaction Time (SRT) and Stroop Test (ST). The SRT test will be used in this study. In the SRT test, the participants will be asked to step as quickly as possible onto the corresponding arrow on the CSRT-MAT and then return to the center. The reaction time (RT) measured from stimulus occurrence to movement initiation (lift off), movement time (MT) measured from movement initiation to step finalization (step down) and total response time (RsT) measured as the sum of RT and MT will be recorded. |
| Secondary | Fullerton Advanced Balance Scale | 8 week | The Fullerton Advanced Balance (FAB) scale will be used to evaluate the balance performance of the participants. This performance-based scale consists of 10 test items assessing functional balance (static and dynamic) status. The individual test items are feet together, eyes closed (1), reach forward to retrieve an object (2), turn in a full circle (3), step up and over a bench (4), tandem walk (5), stand on one leg (6), stand on foam, eyes closed (7), two-footed jump (8), walk with head turns (9) and reactive postural control (10). Each test item is scored using a 0-4 scale. The highest score is 40 points, and the lowest is zero. Higher scores indicate better balance abilities. |
| Secondary | Nintendo Wii Balance Board- Weight distribution | 8 weeks | The Nintendo Wii Balance board uses Bluetooth technology and has four pressure sensors that monitor the user's weight and center of balance (the point where an imaginary line drawn vertically through the center of pressure intersects the surface of the Balance Board). This device consists of 4 sensors and a force platform on which these components are placed. Weight distribution will be measured with eyes open and eyes closed on the platform. The right- left and anterior - posterior distribution of weight will be recorded as a percentage. |
| Secondary | Dynamic Gait Index | 8 week | The Dynamic Gait Index (DGI) will be used to assess postural control when walking. The scale assess person's ability to perform various gait tasks such as walking at various speeds, walking with horizontal and vertical head motions, turning while walking, walking over obstacles, turning around obstacles, and stair climbing. The scale consists of eight items, each of which is rated on a scale of 0 to 3. (0 means severe impairment, 3 means normal ability). The optimal DGI score is 24, and subjects with scores of 19 or lower are more likely to fall. |
| Secondary | Dizziness Handicap Inventory | 8 week | The DHI is a 25-item self assessment scale designed to evaluate the self-perceived handicap caused by dizziness. Answers are graded 4 for the response yes, 2 for sometimes, and 0 for no. The scale identifies 3 types of difficulty associated with dizziness: functional difficulties (9 items, representing 36 points in total), emotional difficulties (9 items, 36 points), and physical difficulties (7 items, 28 points). Thus, the scores on the DHI range from 0 (no handicap) to 100 (significant perceived handicap).The total score can be classified as mild (0-30), moderate (\>30-60), and severe (\>60-100) handicap. |
| Secondary | Vestibular Disorders Activities of Daily Living Scale | 8 week | This scale evaluates the effect of vertigo and balance disorders on independence in routine activities of daily living. Functional (12 questions), ambulation (9 questions), instrumental (7 questions) measures the level of independence in a total of 28 daily living activities. Functional: Includes items on personal care and close relationships, ambulation: items on walking and wandering and instrumental: household chores and hobby activities. In the rating system, it increases from 1 to 10, from being 'independent' to being 'totally dependent'. If the person does not usually do that skill or does not want to respond, he or she marks the "I don't do the activity" section.The sum of the scores of each subsection gives the total score. Functional skills (12-120 points), ambulation skills (9-90 points), instrumental skills (7-70 points) are scored between 28-280 points in total. A low total score indicates the independence of the individual in activities of daily living. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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