Effects of Task-oriented Training in Patients With Peripheral Vestibular Hypofunction

August 24, 2023 updated by: Yasemin Apaydın, Gazi University

Investigation of the Effects of Task-Oriented Training on Balance and Gait in Patients With Peripheral Vestibular Hypofunction

The peripheral vestibular disorder is a heterogeneous disorder that occurs due to unilateral or bilateral involvement of the peripheral vestibular organs in the inner ear, characterized by dizziness, balance disorder, visual blurring with head movements, postural instability, and gait disturbance. In the treatment of vestibular disorders, medical and surgical approaches, as well as vestibular rehabilitation are included. Vestibular rehabilitation should aim at repetitive stimulation of the vestibular sensory organs and improving peripheral sensory inputs by providing strong synaptic plasticity between the hair cells in these organs and the damaged parts of the vestibular system. According to this information, task-oriented training based on the practice of the task in the real environment with plenty of repetition seems to be a suitable method for the requirements of the treatment of vestibular disorders. This study was planned to examine the effects of task-oriented training on balance and gait in patients with peripheral vestibular disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with peripheral vestibular disorders refrain from moving because of the increase in dizziness and fear of falling. These patients prefer to stay still and limit themselves even in simple daily life activities such as vacuuming, cleaning the table, and walking. From this point of view, it is thought that using the tasks in daily life or the activities that form the basis of these tasks in treatment as in task-oriented training will reduce the activity limitations caused by vestibular disorders.

In the recovery of the vestibular system, it is important to practice the functions that increase the symptoms with many repetitions. For example, symptoms that occur without head movement in the acute period after vestibular injury resolve rapidly, and disappear to a large extent as vestibular compensation develops. However, as the disease becomes chronic, losses occur in afferent inputs from the vestibular system and cause a negative effect on dynamic reflex functions. Therefore, vestibular rehabilitation should be aimed to stimulate the vestibular sensory organs repeatedly and to improve peripheral sensory inputs by providing strong synaptic plasticity between the hair cells in these organs and the damaged parts of the vestibular system. According to this information, task-oriented training based on the practice of the task in the real environment with plenty of repetition seems to be a suitable method for the requirements of the treatment of vestibular disorders.

In addition, there is evidence that task-oriented training improves balance, mobility, and gait reduces the risk of falls, and improves the quality of life in neurological diseases such as Stroke, Multiple Sclerosis, and Parkinson's disease. This information supports the investigators' idea that task-oriented training may also be beneficial in improving balance and walking performance, which are the main symptoms of peripheral vestibular disorder.

On the other hand, when the investigators examine the literature, there is no study examining the effects of task-oriented education in patients with peripheral vestibular disorders.

The primary aim of this study is to examine the effects of task-oriented training on vertigo, dizziness, balance, gait and falls in patients with peripheral vestibular disorders. The secondary aim of the investigators' study is to examine the effects of task-oriented training on disability level and quality of life in patients with peripheral vestibular disorders.

Study Type

Interventional

Enrollment (Actual)

28

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

  • Turkey
      • Ankara, Turkey, 06490
        • Gazi University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Receiving a diagnosis of peripheral vestibular disorder by a specialist physician
  • Being between the ages of 18-65
  • Not having an inability to prevent the exercise
  • Not having an Orthopedic, Neurological, Rheumatological, etc., which may cause balance disorder.

Exclusion Criteria:

  • Having cognitive dysfunction that may affect the research results.
  • Having a history of cerebrovascular accident, fainting, or epilepsy
  • Being included in the vestibular rehabilitation program in the last 1 month
  • Being in the acute phase of vestibular disease
  • Having benign paroxysmal positional vertigo
  • Using vestibular suppressant and centrally acting drugs in the last 3 months

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: Task-oriented training group
Among the patients in the task-oriented training group, 12 sessions were given routinely, 3 days a week, for 4 weeks. Task-oriented training consisted of 25 different stations in total, including 9 different gaze stabilization training, 7 balance training, and 9 gait training stations. Gaze stabilization exercises included head-fixed right-left eye movements, head-fixed up-down eye movements, eye fixed right-left head movements, eye fixed up-down head movements, head and eye opposing movements (right-left/ up-down), saccadic and pursuit eye movements (right-left/ up-down). Balance and gait training included these exercises: rolling on the mat, vertical rotation, spinning on a rotary disc, standing on balance bord, jumping, playing dart, reaching, walking forward, walking with head movements (right-left/ up-down), tandem walking, '8' shape walking, walking by picking something up from the ground, walking over an obstacle, walking on treadmill, climbing and descending stairs.
Other: Task-oriented training
Task-oriented training is defined as an approach based on movement science and motor learning, where the patient "makes functional movements specific to a certain task and receives feedback". Task-oriented training focuses on improving performance on functional tasks through targeted practice and repetition.
Active Comparator: Control group
Among the patients in the control group with peripheral vestibular disorders, 12 sessions were given routinely, 3 days a week, for 4 weeks. They were asked to perform gaze stabilization exercises for 1 min. Gaze stabilization exercises consist of head-fixed right-left eye movements, head-fixed up-down eye movements, eye fixed right-left head movements, and eye fixed up-down head movements.
Other: Control group
Gaze stabilization exercises included head-fixed right-left eye movements, head-fixed up-down eye movements, eye fixed right-left head movements, and eye fixed up-down head movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posturography
Time Frame: 4 weeks
The posturography evaluation was made using the Synapsis Posturography System® (SPS®, version 3.0). All patients performed the Sensory Organization Test (SOT), this test representing the association between static and sway-referenced support in posturography under three conditions - eyes open (eo), eyes closed (ec), mislead vision. SOT objectively analyses the three sensory systems that contribute to postural control: somatosensory, visual and vestibular, by systematically eliminating useful visual or support information, creating also sensory conflict situations. We registered the results obtained under six conditions: eyes open, eyes closed and looking sway-referenced screen on static surface and sway-referenced surface. The feet position of the patient on the platform was - 2 cm spacing apart of the heels and a 30º angle between, corresponding to the foot size. Each test was performed barefoot, in standing position, 2 trials of 20 seconds for each test.
4 weeks
G-walk® spatio-temporal gait analysis system (speed)
Time Frame: 4 weeks
The gait speed was assessed by G-walk® spatio-temporal gait analysis system. The assessment began with the participant standing still in an orthostatic standing position. The position had to be maintained for a few seconds until the end of the stabilization of the G-Walk device. The participants were instructed to walk on a 8 meter track. The boundaries of the track were marked to ensure a correct analysis. The participants walked at their natural speed along an absolutely straight path. A successful trial was characterized by the participant completing the 8-meter track and returning to the starting point. The parameter that were evaluated using the G-Walk were; speed (meter/seconds).This parameter are recorded by G-walk and transferred to the computer.
4 weeks
G-walk® spatio-temporal gait analysis system (cadence)
Time Frame: 4 weeks
The cadence was assessed by G-walk® spatio-temporal gait analysis system. The gait assessments began with the standing position. The position had to be maintained for a few seconds until the end of the stabilization of the G-Walk device. On an 8 meter track, the participants were asked to walk. For a proper examination, the track's limits were delineated. The participants followed a perfectly straight line while moving at their usual pace. The participant's completion of the 8-meter track and arrival back at the starting point defined a successful trial. Cadence was the parameter that was assessed using the G-Walk.This parameter is sent to the computer after being recorded by G-walk.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity and frequency of vertigo and dizziness (Visual analog scale (VAS))
Time Frame: 4 weeks

In order to evaluate the severity of vertigo and dizziness, the patients were shown a 12.5×17.5 cm Visual analog scale (VAS) card in which the expressions were written in 36 points. VAS was used to determine the severity of vertigo and dizziness. Patients were asked to rate 1=no vertigo/dizziness, 2-3=mild, 4-5=moderate, 6-7=severe, 8-9=very severe, and 10=extreme.

In order to evaluate the frequency of vertigo and dizziness in the last 7 days, a 13×18 cm VAS scale card in which the expressions were written in 36 points was used. Patients were asked to rate; 1= no vertigo/dizziness, 2-3= 1-5 times a week, 4-5= 1-3 times a day, 6-7= 4-10 times a day, 8-9= >10 times a day, 10= continuous vertigo.
4 weeks
Disability level and quality of life
Time Frame: 4 weeks

The Dizziness Handicap Inventory (DHI) evaluates the disability level and quality of life in patients with dizziness. The scale measures the functional, physical and emotional effects of dizziness in the last 1 month. The scale, which consists of 25 questions in total, has 3 subsections: physical (7 questions), emotional (9 questions) and functional (9 questions).

The scale, which has 3 answer options as 'yes', 'sometimes' and 'no' for each question, has a score of 4, 2 and 0 for each answer, respectively. The maximum score is 100, with 28 for the physical subsection and 36 for the emotional and functional subsections. According to this; 0-30 points are indicated as light handicap; 30-60 points are indicated as moderate disability and 60-100 points are indicated as severe disability.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Director: Arzu Güçlü-Gündüz, Prof, PROFESSOR DOCTOR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2020

Primary Completion (Actual)

November 17, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Estimated)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25901600-604.01.01-12

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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