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Completed

NCT Number: NCT02622516

Cervical Mobility and Vestibular Rehabilitation

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 .

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Key information

Conditions

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

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group (IG)

Other

Therapeutic approaches to this proposal are intended to promote muscle relaxation to increase range of motion and analgesia of neck and shoulder girdle region, as well as the fascial release these regions with the intervention of cervical global pompage, exercises for body mobility for upper limb and trunk in the positions supine, lateral and dorsal, sitting and standing and gradually followed by proprioceptive exercises to the lower limbs and trunk in sitting and standing positions with aid devices such as foams, pool baguettes, balance boards, Swiss balls, steps, trampolines and BOSU ( BOSU® Home Balance Trainer ).

The exercises will be held in individual treatments lasting sixty minutes with a frequency of once a week for all group members.

Other names: Multisensory Exercises Protocol of Vestibular Rehabilitation

Control group (CG)

Other

The exercises consist of eye movements in different directions, slow and fast; 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.

The exercises will be held in individual treatments lasting sixty minutes with a frequency of once a week for all group members.

Other names: Conventional Protocol of Cawthorne & Cooksey Exercises

Primary outcomes

  1. 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

  1. Timed Up and Go test (TUG)

    Time frame: 12 weeks

    Which evaluates the risk of falls. Starting from the sitting position, analyzes the transfer from sitting to standing, stability and progress of the ongoing changes without using compensatory strategies .

  2. Functional Reach test (FRT)

    Time frame: 12 weeks

    Measure the mobility test with emphasis on the assessment of the balance. It is performed by asking the individual to stand up, next to a wall with shoulder flexion 90° and upper limbs in extension. Then he asks the individual to conduct an anterior flexion of the trunk, without the heels lose contact with the ground. Performance is measured by the distance traveled by the body's displacement (in centimeters), with the mean of three test attempts.

  3. Agility Test

    Time frame: 12 weeks

    Agility test to evaluate the agility and dynamic balance.

  4. Dizziness Handicap Inventory (DHI)

    Time frame: 12 weeks

    This questionnaire was developed and validated in order to evaluate the self- perception of the tax effects of dizziness on quality of life.

  5. Vestibular Disorders Activities of Daily Living Scale Questionaire (VADL)

    Time frame: 12 weeks

    Evaluates the impact of dizziness and body imbalance in daily activities of vestibular individuals.

  6. Visual Analog Scale (VAS) of Dizziness

    Time frame: 12 weeks

    Which indicates the intensity of vertigo symptoms, and varies on a numerical scale from zero to ten, where zero indicates the absence of dizziness and ten, the worst intensity of dizziness.

  7. Fleximeter

    Time frame: 12 weeks

    Fleximeter to assess the range of motion of the cervical spine, consisting in a gravity - dependent inclinometer, whose range is a degree, attached to a velcro tape to be secured in head circumference participant.

Sponsors and collaborators

Lead sponsor

Viviane de Souza Pinho Costa

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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