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Clinical Trials/NCT05871385
NCT05871385
Completed
Not Applicable

rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT

Beni-Suef University2 sites in 1 country56 target enrollmentApril 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Vestibular Disorders
Sponsor
Beni-Suef University
Enrollment
56
Locations
2
Primary Endpoint
Postural stability
Status
Completed
Last Updated
last year

Overview

Brief Summary

Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular rehabilitation program on balance and postural stability in patients with vestibular dizziness

Detailed Description

The subjects of both genders with age 40 to 65 will be allocated randomly into two equal groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.

Registry
clinicaltrials.gov
Start Date
April 23, 2023
End Date
December 27, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Samir Abdelkhalik Youssef

lecturer at faculty of physical therapy

Beni-Suef University

Eligibility Criteria

Inclusion Criteria

  • Diagnosis with peripheral vestibular disorders from audiologist or neurologist.
  • The patient's age will be ranged from forty five to seventy years old.
  • Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
  • Symptoms of vertigo and nystagmus lasting from seconds to one minute.
  • Vertigo that arises from changes in head position related to gravity.
  • Patients who experienced symptoms for more than three months (chronic patients)
  • Patients were selected to be ambulant.
  • Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.
  • All patients were medically stable, controlled with medical drugs for at least three months and failed to medical treatment with no other physical, mental or cognitive disorders.

Exclusion Criteria

  • Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
  • Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
  • Previous surgery of the ear.
  • Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
  • Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension \>190/110...).
  • Pacemaker or other implanted electrically sensitive device.
  • Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
  • Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression....).
  • Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
  • Alcohol abuse.

Outcomes

Primary Outcomes

Postural stability

Time Frame: change from baseline to 8 weeks after intervention

Computerized dynamic Posturography- Scores ranging zero min score and 100 max score

Visual Vertigo Analogue Scale

Time Frame: change from baseline to 8 weeks after intervention

Indicate the amount of dizziness you experience in different situations

Secondary Outcomes

  • Berg balance scale(change from baseline to 8 weeks after intervention)

Study Sites (2)

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