Clinical trial NCT02622516: Cervical Mobility and Vestibular Rehabilitation
Official title: Effectiveness of Additional Protocol Exercises for Cervical Mobility and Proprioception in Vestibular Rehabilitation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Keywords: Rehabilitation
Physical Therapy Specialty
Postural Balance
Vertigo
Dizziness
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vertigo, dizziness and imbalance are the main symptoms of vestibular dysfunction. They can lead to physical consequences, such as the reduction of postural control and falls, psychological and / or psychiatric consequences such as anxiety and depression, panic and cognitive changes, especially in the elderly. It is known that individuals affected by these disorders may improve with the completion of vestibular rehabilitation protocol.Treatment protocols can introduce variability of exercises to control the signs and symptoms related to vestibular diseases, in order to customize the treatment to affected individuals .

Detailed description: The objective of this study will be to compare the effectiveness of a multisensory exercises protocol of vestibular rehabilitation versus conventional protocol of Cawthorne \& Cooksey exercises for the treatment of patients with vestibular disorders. Methods: There will be a Clinical Trial Random, blind, Hidden Allocation. The sample will consist of 54 subjects submitted to two different protocols of vestibular rehabilitation exercises (Intervention Group (IG) and Control Group (CG)), to be held with individual treatment once a week, totaling 12 attendences. All will be assessed before and after treatment and the main variables analyzed are general characteristics of the clinical signs and symptoms caused by vestibular diseases, perception of quality of life and functional capacity paras activities of daily life, body flexibility, range of motion in the region cervical, parameters of static and dynamic postural balance and the perception of the results promoted by the treatment of vestibular rehabilitation and will compare the results of the groups. Expected results: It is expected, clinically, that subjects who receive treatment through multisensory exercises Protocol for VR present reduction of clinical signs and symptoms of dizziness, complaints of pains and cervical joint limitations, parameters of improvement related to postural balance, aspects of functional capacity and quality of life.

Eligibility criteria: Inclusion Criteria:

* People from the age of majority (18 years) to 69 years, considered by the population division in youth, adults and older people to 69 years according to the World Health Organization (WHO) , of both genders, with commitment by diagnosed peripheral vestibular disorders clinically by a doctor, including the peripheral vestibular type Benign Paroxysmal Positional Vertigo (BPPV), with vestibular symptoms, with higher scores than or equal to a spot on the Visual Analogue Scale (VAS) Dizziness or higher rank than or equal to 16 points in the questionnaire dizziness Handicap Inventory (DHI).

Exclusion Criteria:

* Elderly aged 70 or more, which have visual impairment and/or total hearing, orthopedic disorders that limit the realization of the proposed activities, nervous system injuries that cause damage engines and/or additional sensitive and diagnostics of Ménière's disease.

Primary outcomes:
measure: Balance Measure from force platform (COP Measure)
timeFrame: 12 weeks
Secondary outcomes:
measure: Timed Up and Go test (TUG)
timeFrame: 12 weeks
measure: Functional Reach test (FRT)
timeFrame: 12 weeks
measure: Agility Test
timeFrame: 12 weeks
measure: Dizziness Handicap Inventory (DHI)
timeFrame: 12 weeks
measure: Vestibular Disorders Activities of Daily Living Scale Questionaire (VADL)
timeFrame: 12 weeks
measure: Visual Analog Scale (VAS) of Dizziness
timeFrame: 12 weeks
measure: Fleximeter
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Norte do Paraná
name: Viviane SP Costa
role: STUDY_DIRECTOR
References:
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citation: Albera R, Ciuffolotti R, Di Cicco M, De Benedittis G, Grazioli I, Melzi G, Mira E, Pallestrini E, Passali D, Serra A, Vicini C. Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo. Acta Otolaryngol. 2003 Jun;123(5):588-93. doi: 10.1080/00016480310001475.
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citation: Han BI, Song HS, Kim JS. Vestibular rehabilitation therapy: review of indications, mechanisms, and key exercises. J Clin Neurol. 2011 Dec;7(4):184-96. doi: 10.3988/jcn.2011.7.4.184. Epub 2011 Dec 29.
citation: Meldrum D, Herdman S, Moloney R, Murray D, Duffy D, Malone K, French H, Hone S, Conroy R, McConn-Walsh R. Effectiveness of conventional versus virtual reality based vestibular rehabilitation in the treatment of dizziness, gait and balance impairment in adults with unilateral peripheral vestibular loss: a randomised controlled trial. BMC Ear Nose Throat Disord. 2012 Mar 26;12:3. doi: 10.1186/1472-6815-12-3.
citation: da Silva RA, Bilodeau M, Parreira RB, Teixeira DC, Amorim CF. Age-related differences in time-limit performance and force platform-based balance measures during one-leg stance. J Electromyogr Kinesiol. 2013 Jun;23(3):634-9. doi: 10.1016/j.jelekin.2013.01.008. Epub 2013 Feb 10.
citation: Horak FB. Postural compensation for vestibular loss and implications for rehabilitation. Restor Neurol Neurosci. 2010;28(1):57-68. doi: 10.3233/RNN-2010-0515.