Clinical trial NCT06019104: Effects of Task-oriented Training in Patients With Peripheral Vestibular Hypofunction
Official title: Investigation of the Effects of Task-Oriented Training on Balance and Gait in Patients With Peripheral Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vestibular Disorders
Keywords: Task-oriented training
Balance
Gait
Vertigo
Dizziness
Quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Posturography
timeFrame: 4 weeks
measure: G-walk® spatio-temporal gait analysis system (speed)
timeFrame: 4 weeks
measure: G-walk® spatio-temporal gait analysis system (cadence)
timeFrame: 4 weeks
Secondary outcomes:
measure: The severity and frequency of vertigo and dizziness (Visual analog scale (VAS))
timeFrame: 4 weeks
measure: Disability level and quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Professor Doctor
name: Arzu Güçlü-Gündüz, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.