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Clinical Trials/NCT02622516
NCT02622516CompletedNot Applicable

Effectiveness of Additional Protocol Exercises for Cervical Mobility and Proprioception in Vestibular Rehabilitation: a Randomized Controlled Trial

Viviane de Souza Pinho Costa0 sites28 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Primary Endpoint
Balance Measure from force platform (COP Measure)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 72 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention Group (IG)

Active Comparator

Participants in the intervention group subjects (IG) will receive physiotherapy treatment in vestibular rehabilitation based on multisensory exercises consisting of the group of therapeutic proposals that stimulation of the vestibular, proprioceptive and visual associated with manual therapy treatment proposed by the techniques cervical global pompage and classic massage therapy on neck and shoulder girdle .

Intervention: Intervention Group (IG) (Other)

Control Group (CG)

Experimental

Participants in the control group subjects (CG) will receive physiotherapy treatment in vestibular rehabilitation based on Cawthorne and Cooksey Exercises, consisting of eye movements in different directions, slowly and quickly; head movements in different planes, with open and closed eyes, slow and fast; and body exercises such as lifting and sit, walk open and closed eyes, up and down ramps and stairs, as well as some activities and ball games.

Intervention: Control Group (CG) (Other)

Outcomes

Primary Outcomes

Balance Measure from force platform (COP Measure)

Time Frame: 12 weeks

To assess postural control by means of a force platform named BIOMEC400 (EMG System Brazil, SP Ltda), and the data sampled at 100 Hz variables will be used: pressure downtown area (A-COP in cm2), average velocity of COP (VEL in cm/sec), amplitude (AMP cm) and average frequency of COP (FM in Hz) in both movement directions: anterior-posterior (A/P ) and medial-lateral (M/L).

Secondary Outcomes

  • Agility Test(12 weeks)
  • Fleximeter(12 weeks)
  • Timed Up and Go test (TUG)(12 weeks)
  • Vestibular Disorders Activities of Daily Living Scale Questionaire (VADL)(12 weeks)
  • Visual Analog Scale (VAS) of Dizziness(12 weeks)
  • Functional Reach test (FRT)(12 weeks)
  • Dizziness Handicap Inventory (DHI)(12 weeks)

Investigators

Sponsor
Viviane de Souza Pinho Costa
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Viviane de Souza Pinho Costa

Viviane

Universidade Norte do Paraná

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