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Cervical Mobility and Vestibular Rehabilitation

Primary Purpose

Vestibular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Group (IG)
Control Group (CG)
Sponsored by
Viviane de Souza Pinho Costa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Diseases focused on measuring Rehabilitation, Physical Therapy Specialty, Postural Balance, Vertigo, Dizziness

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Intervention Group (IG)

    Control Group (CG)

    Arm Description

    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 .

    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.

    Outcomes

    Primary Outcome Measures

    Balance Measure from force platform (COP Measure)
    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

    Timed Up and Go test (TUG)
    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 .
    Functional Reach test (FRT)
    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.
    Agility Test
    Agility test to evaluate the agility and dynamic balance.
    Dizziness Handicap Inventory (DHI)
    This questionnaire was developed and validated in order to evaluate the self- perception of the tax effects of dizziness on quality of life.
    Vestibular Disorders Activities of Daily Living Scale Questionaire (VADL)
    Evaluates the impact of dizziness and body imbalance in daily activities of vestibular individuals.
    Visual Analog Scale (VAS) of Dizziness
    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.
    Fleximeter
    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.

    Full Information

    First Posted
    December 2, 2015
    Last Updated
    August 29, 2017
    Sponsor
    Viviane de Souza Pinho Costa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02622516
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Viviane de Souza Pinho Costa

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vestibular Diseases
    Keywords
    Rehabilitation, Physical Therapy Specialty, Postural Balance, Vertigo, Dizziness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group (IG)
    Arm Type
    Active Comparator
    Arm Description
    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 .
    Arm Title
    Control Group (CG)
    Arm Type
    Experimental
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Intervention Group (IG)
    Other Intervention Name(s)
    Multisensory Exercises Protocol of Vestibular Rehabilitation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control Group (CG)
    Other Intervention Name(s)
    Conventional Protocol of Cawthorne & Cooksey Exercises
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Balance Measure from force platform (COP Measure)
    Description
    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).
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Timed Up and Go test (TUG)
    Description
    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 .
    Time Frame
    12 weeks
    Title
    Functional Reach test (FRT)
    Description
    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.
    Time Frame
    12 weeks
    Title
    Agility Test
    Description
    Agility test to evaluate the agility and dynamic balance.
    Time Frame
    12 weeks
    Title
    Dizziness Handicap Inventory (DHI)
    Description
    This questionnaire was developed and validated in order to evaluate the self- perception of the tax effects of dizziness on quality of life.
    Time Frame
    12 weeks
    Title
    Vestibular Disorders Activities of Daily Living Scale Questionaire (VADL)
    Description
    Evaluates the impact of dizziness and body imbalance in daily activities of vestibular individuals.
    Time Frame
    12 weeks
    Title
    Visual Analog Scale (VAS) of Dizziness
    Description
    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.
    Time Frame
    12 weeks
    Title
    Fleximeter
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Viviane SP Costa
    Organizational Affiliation
    Universidade Norte do Paraná
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23549053
    Citation
    Adamo DE, Pociask FD, Goldberg A. The contribution of head position, standing surface and vision to postural control in young adults. J Vestib Res. 2013;23(1):33-40. doi: 10.3233/VES-130473.
    Results Reference
    result
    PubMed Identifier
    12875580
    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.
    Results Reference
    result
    PubMed Identifier
    15697162
    Citation
    Badke MB, Miedaner JA, Shea TA, Grove CR, Pyle GM. Effects of vestibular and balance rehabilitation on sensory organization and dizziness handicap. Ann Otol Rhinol Laryngol. 2005 Jan;114(1 Pt 1):48-54. doi: 10.1177/000348940511400109.
    Results Reference
    result
    PubMed Identifier
    24676704
    Citation
    Ricci NA, Aratani MC, Caovilla HH, Cohen HS, Gananca FF. Evaluation of properties of the Vestibular Disorders Activities of Daily Living Scale (Brazilian version) in an elderly population. Braz J Phys Ther. 2014 Mar-Apr;18(2):174-82. doi: 10.1590/s1413-35552012005000144. Epub 2014 Mar 19.
    Results Reference
    result
    PubMed Identifier
    22259614
    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.
    Results Reference
    result
    PubMed Identifier
    22449224
    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.
    Results Reference
    result
    PubMed Identifier
    23403137
    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.
    Results Reference
    result
    PubMed Identifier
    20086283
    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.
    Results Reference
    result

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    Cervical Mobility and Vestibular Rehabilitation

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