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

NCT06019104 | Completed

• 1 other identifier: 25901600-604.01.01-12
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vestibular Disorders

Keywords

Task-oriented training; Balance; Gait; Vertigo; Dizziness; Quality of life

Outcome Measures

Primary Outcomes (3)

• Posturography

  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)

  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)

  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 Outcomes (2)

• The severity and frequency of vertigo and dizziness (Visual analog scale (VAS))

  4 weeks

• Disability level and quality of life

  4 weeks

Study Arms (2)

Task-oriented training group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Task-oriented training 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.

Task-oriented training group

Control group 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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 31741209 BACKGROUND

• 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.

  PMID: 32310197 BACKGROUND

• 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.

  PMID: 32250333 BACKGROUND

• 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.

  PMID: 27390437 BACKGROUND

• 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.

  PMID: 26111348 BACKGROUND

• 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.

  PMID: 27406654 BACKGROUND

MeSH Terms

Conditions

Vertigo; Dizziness

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Arzu Güçlü-Gündüz, Prof

  Professor Doctor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: August 31, 2023
• Study Start: June 1, 2020
• Primary Completion: November 17, 2021
• Study Completion: December 1, 2021
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)