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Vestibular DisorderNCT04261283

Circuit Training on Vertigo, Oscillopsia and Dizziness in Vestibular Hypo Function Hypo- Functions

A study testing Experimental and Active Comparator in people with Vestibular Disorder, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this research, the main purpose is to determine the effects of Circuit Training consisting of Structured Vestibular rehabilitation Program under the strict supervision of Neuro-Therapist versus Medicines and General (simple) Rehabilitation (only Home-based) in community-dwelling population of people diagnosed with… Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Vestibular Disorder
What is being tested?
Experimental and Active Comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 sitePakistan
Study dates
1 Jul 2020to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients diagnosed with Vestibular Disorders/
  • patient with Dysfunctions by ENT specialist.

Who cannot join

  • Patients diagnosed with BPPV.
  • Central nervous system (CNS) involvement (significant neurological disorders)
  • Musculoskeletal (MSK) system deficits (orthopedic disorders)
  • Uncontrolled hypertension (HTN)
  • Heart diseases
  • Psychosocial abnormalities
  • Psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Lahore, Punjab Province

Other trials in Pakistan

About this study

Official title: Effects of Circuit Training on Vertigo, Oscillopsia and Dizziness in Patients With Vestibular Hypo-function

In this research, the main purpose is to determine the effects of Circuit Training consisting of Structured Vestibular rehabilitation Program under the strict supervision of Neuro-Therapist versus Medicines and General (simple) Rehabilitation (only Home-based) in community-dwelling population of people diagnosed with Vestibular disorders. A booklet consisting of general instructions, simple vestibular exercises which are to be made a part of daily routine, specific diet plan and specific precautions to be taken by patients reporting with vertigo, oscillopsia and dizziness will also be provided to all the patients. This is a community service addition, added so that everyone in the society can have easy access to the instructions, will be cost effective, and will reduce their visits to the therapist.

Read the detailed description

People diagnosed with vestibular disorders often experience dizziness , oscillopsia, trouble with vision, balance or mobility. The vestibular disorders that are called unilateral and peripheral (UPVD) are those that affect one side of the vestibular system (unilateral)and (BPVD) are those affect both sides of the vestibular system (bilateral) and only the portion of the system that is outside of the brain (peripheral-part of the inner ear). Examples of these disorders include benign paroxysmal positional vertigo (BPPV), vestibular neuritis, labyrinthitis, one-sided Ménière's disease or vestibular problems following surgical procedures such as labyrinthectomy or removal of an acoustic neuroma. Vestibular rehabilitation for these disorders is becoming increasingly used and involves various movement-based regimes.

Dizziness, oscillopsia and disequilibrium are common complaints reported by adults during visits to their doctor. Dizziness, oscillopsia, vertigo and disequilibrium are not a disease-they are symptoms that can result from a vestibular disorder or from difficulties unrelated to the inner ear, such as cardiovascular, neurological, metabolic, vision, or psychological disorders. However, as many as 45% of people with dizziness symptoms have problems in the vestibular system (balance organs of the inner ear.

Vestibular rehabilitation therapy (VRT) is an exercise-based program for reducing the symptoms of vertigo, dizziness, oscillopsia and disequilibrium with vestibular pathology (disease or disorder). A common neuro-otological approach for managing such symptoms is to prescribe medication that suppresses vestibular function. However, in the long term, such suppressants can interfere with a person's ability to make necessary adaptations. In addition, many of these medications cause drowsiness that may limit a person's ability to be active.

Vestibular habituation exercises have been recommended for these non-Ménière's patients. Although the exercises are popular, there are only a few studies in patients with chronic unilateral vestibular dysfunction. Those studies were performed with limited cases or with a wide variety of diagnoses. Herdman et al.,in their review, stressed that studies were retrospective, nonrandomized, consisting of groups that were not comparable, uncontrolled studies and, although they offer interesting descriptions of the patient population, do not provide the evidence necessary to justify the use of these exercises for treatment.

the previous study conducted a research in 2009 to find the Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction, a randomized controlled study. Their objective was to evaluate the short-term effects of vestibular rehabilitation on a symptom, disability, balance, and postural stability in patients with chronic unilateral vestibular dysfunction. Significant improvements were seen in symptom, disability, balance, and postural stability in chronic unilateral vestibular dysfunction after an exercise program.

in 2013 study was conducted on finding out the effects of Vestibular rehabilitation with virtual reality in Meniere disease. Their aim was to verify the effect of a virtual reality-based balance rehabilitation program for patients with Meniere disease. They concluded that Virtual reality-based balance rehabilitation effectively improved dizziness, quality of life, and limit of stability of patients with Meniere's disease.

in 2006 a study was conducted to Compare between Oculomotor Rehabilitation and Vestibular Electrical Stimulation in Unilateral Peripheral Vestibular Deficit. The aim of their study was to evaluate the effects of oculomotor rehabilitation (group 2) on static balance and a dizziness handicap and to compare those with the effects to vestibular electrical stimulation (group 1). Analysis of the equilibrium system subcomponents did not show any variation. Oculomotor exercises, employed in most rehabilitative protocols and including head movements to improve vestibular adaptation, have proved to reduce the perceived overall impairment and postural sway in patients with recent unilateral vestibular disorders, even though the disorders are not associated with head movements. Comparison of our two study groups did not show any significant difference, revealing that both forms of therapy are effective.

in 2013, a study evaluated the feasibility of integrating vestibular rehabilitation and cognitive behaviour therapy (VR-CBT) for people with persistent dizziness in primary care. This was a prospective single-group pre- and post-test study. Participants reported that the VR-CBT was relevant and led to an improvement in function.Dizziness Handicap Inventory (DHI) scores improved beyond a minimal important change in two out of five participants, and preferred gait velocity increased beyond a minimal important change in two out of three participants. The current tests and VR-CBT treatment protocols were feasible. Some changes are suggested to optimize the protocols, before conducting a randomized controlled trial.

Up-till now a properly structured Circuit Training consisting of Vestibular Rehabilitation exercises, in which each exercise is designed such that it specifically focus on each and every symptom separately has not developed. So, in this research a Circuit Training consisting of Vestibular exercises, each exercise included is focusing on a specific goal separately

Being tested
Experimental, Active Comparator
Keywords
Dizziness, Exercise, Vestibular, Vertigo
Medical subject headings
Vestibular Diseases, Dizziness, Motor Activity, Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalOther

    The Circuit Training will be consisting of:

    1. Habituation Exercises
    2. Exercises for the gaze stability (The two exercises are specifically for the patients who reported a high score on oscillopsia severity questionnaire
    3. Exercises to improve Saccade Latency.
    4. Adaptation Exercises
    5. Substitution Exercises
    6. Postural Control Exercises
    7. General Conditioning Activities
    8. Cawthorne-Cooksey Exercises
    9. Ocular Motor Exercises
    10. Gait Exercises
    11. Treatment to Decrease Sensitivity to Motion in the Environment
  • Active ComparatorOther

    Medicines as prescribed by the ear, nose, and throat (ENT) specialist and Home-based exercise Programme (Simple and general vestibular rehabilitation exercises) will be recommended to the patients to perform. ( Not under the supervision of neuro-therapist)

Study groups in NCT04261283
Study groupRoleWhat they receive
Circuit TrainingExperimentalSpecific exercise are designed in circuit training
Receives: Other: Experimental
Control GroupActive comparatorConventional treatment
Receives: Other: Active Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Vertigo Analogue Scale

    changes from the baseline,this scale is used to measure the intensity of symptoms, 0-10 cm line zero anchor representing no dizziness and 10 anchor representing extreme dizziness or activity avoided due to dizziness

    Measured: 4 week

  2. Vertigo Handicap Questionnaire

    changes from the baseline, this scale is used to assess the disability level in vestibular impairment. 25 Items measuring Four dimensions(restriction of Activity, social Anxieties, fear of Vertigo, severity of episodes). Item scaling is on 5 points likert scale from 0 (no handicap) to 4 (maximum handicap)

    Measured: 4 week

  3. Dizziness Handicap Inventory

    changes from the baseline, this test is used to determine the physical, functional and emotional components of Dizziness. Item Scores are summed, there is a maximum score of 100 (28 points for physical, 36 for emotional and 36 for functional and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness. Answers are graded: 0 (no), 2 (sometimes), 4 (Yes)

    Measured: 4 week

Secondary outcomes (2)
  1. Vestibular Disorders Activities of Daily Living Scale

    changes from the baseline , this is scale used to asses the level of activities

    Measured: 4 week

  2. Berg Balance Scale

    changes from the baseline, Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.

    Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261283
Sponsor's protocol ID
REC/Lhr/20/2001 Asna Waseem
Status last verified
Mar 2021
First submitted
18 Dec 2019
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Later on will be publish

Publications

  • Johansson M, Akerlund D, Larsen HC, Andersson G. Randomized controlled trial of vestibular rehabilitation combined with cognitive-behavioral therapy for dizziness in older people. Otolaryngol Head Neck Surg. 2001 Sep;125(3):151-6. doi: 10.1067/mhn.2001.118127.

    PubMed 11555746
  • Herdman SJ, Blatt PJ, Schubert MC. Vestibular rehabilitation of patients with vestibular hypofunction or with benign paroxysmal positional vertigo. Curr Opin Neurol. 2000 Feb;13(1):39-43. doi: 10.1097/00019052-200002000-00008.

    PubMed 10719648
  • Giray M, Kirazli Y, Karapolat H, Celebisoy N, Bilgen C, Kirazli T. Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. Arch Phys Med Rehabil. 2009 Aug;90(8):1325-31. doi: 10.1016/j.apmr.2009.01.032.

    PubMed 19651266
  • Kristiansen L, Magnussen LH, Juul-Kristensen B, Maeland S, Nordahl SHG, Hovland A, Sjobo T, Wilhelmsen KT. Feasibility of integrating vestibular rehabilitation and cognitive behaviour therapy for people with persistent dizziness. Pilot Feasibility Stud. 2019 May 20;5:69. doi: 10.1186/s40814-019-0452-3. eCollection 2019.

    PubMed 31139431

Questions about this trial

What is this clinical trial studying?

A study testing Experimental and Active Comparator in people with Vestibular Disorder, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Vertigo Analogue Scale (time frame: 4 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04261283, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.

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