Cervical Mobility and Vestibular Rehabilitation

Vestibular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622516
• Other study ID #: Viviane-Unopar
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: August 29, 2017
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2017
• Source: Universidade Norte do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vestibular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Viviane de Souza Pinho Costa

References & Publications (8)

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. — View 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 pa — View 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. — View 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. — View 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. — View 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. Review. — View 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 ad — View Citation

Ricci NA, Aratani MC, Caovilla HH, Cohen HS, Ganança 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. Epub 2014 Mar 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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 .	12 weeks
Secondary	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.	12 weeks
Secondary	Agility Test	Agility test to evaluate the agility and dynamic balance.	12 weeks
Secondary	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.	12 weeks
Secondary	Vestibular Disorders Activities of Daily Living Scale Questionaire (VADL)	Evaluates the impact of dizziness and body imbalance in daily activities of vestibular individuals.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks