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Cervical Mobility and Vestibular Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02622516
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Viviane de Souza Pinho Costa, Universidade Norte do Paraná

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 .

Condition or disease Intervention/treatment Phase
Vestibular Diseases Other: Intervention Group (IG) Other: Control Group (CG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Additional Protocol Exercises for Cervical Mobility and Proprioception in Vestibular Rehabilitation: a Randomized Controlled Trial
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention Group (IG)
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 .
Other: Intervention Group (IG)

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 Name: Multisensory Exercises Protocol of Vestibular Rehabilitation

Experimental: Control Group (CG)
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.
Other: Control Group (CG)

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 Name: Conventional Protocol of Cawthorne & Cooksey Exercises




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622516


Sponsors and Collaborators
Viviane de Souza Pinho Costa
Investigators
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Study Director: Viviane SP Costa Universidade Norte do Paraná

Publications of Results:

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Responsible Party: Viviane de Souza Pinho Costa, Viviane, Universidade Norte do Paraná
ClinicalTrials.gov Identifier: NCT02622516    
Other Study ID Numbers: Viviane-Unopar
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Viviane de Souza Pinho Costa, Universidade Norte do Paraná:
Rehabilitation
Physical Therapy Specialty
Postural Balance
Vertigo
Dizziness
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases