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

NCT ID: NCT06019104

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vestibular Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Task-oriented training Balance Gait Vertigo Dizziness Quality of life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Task-oriented training

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gazi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasemin Apaydın

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arzu Güçlü-Gündüz, Prof

Role: STUDY_DIRECTOR

Professor Doctor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Soke F, Guclu-Gunduz A, Kocer B, Fidan I, Keskinoglu P. Task-oriented circuit training combined with aerobic training improves motor performance and balance in people with Parkinson's Disease. Acta Neurol Belg. 2021 Apr;121(2):535-543. doi: 10.1007/s13760-019-01247-8. Epub 2019 Nov 18.

Reference Type BACKGROUND
PMID: 31741209 (View on PubMed)

Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial. NeuroRehabilitation. 2020;46(3):343-353. doi: 10.3233/NRE-203029.

Reference Type BACKGROUND
PMID: 32310197 (View on PubMed)

Tramonti C, Di Martino S, Chisari C. An intensive task-oriented circuit training positively impacts gait biomechanics in MS patients. NeuroRehabilitation. 2020;46(3):321-331. doi: 10.3233/NRE-192997.

Reference Type BACKGROUND
PMID: 32250333 (View on PubMed)

Kim B, Park Y, Seo Y, Park S, Cho H, Moon H, Lee H, Kim M, Yu J. Effects of individualized versus group task-oriented circuit training on balance ability and gait endurance in chronic stroke inpatients. J Phys Ther Sci. 2016 Jun;28(6):1872-5. doi: 10.1589/jpts.28.1872. Epub 2016 Jun 28.

Reference Type BACKGROUND
PMID: 27390437 (View on PubMed)

Arnold SA, Stewart AM, Moor HM, Karl RC, Reneker JC. The Effectiveness of Vestibular Rehabilitation Interventions in Treating Unilateral Peripheral Vestibular Disorders: A Systematic Review. Physiother Res Int. 2017 Jul;22(3). doi: 10.1002/pri.1635. Epub 2015 Jun 25.

Reference Type BACKGROUND
PMID: 26111348 (View on PubMed)

Hillier S, McDonnell M. Is vestibular rehabilitation effective in improving dizziness and function after unilateral peripheral vestibular hypofunction? An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Aug;52(4):541-56. Epub 2016 Jul 12.

Reference Type BACKGROUND
PMID: 27406654 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25901600-604.01.01-12

Identifier Type: -

Identifier Source: org_study_id