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Clinical Trials/NCT05831618
NCT05831618
Not yet recruiting
Not Applicable

New Rehabilitation Protocol for Patients With Persistent Postural Perceptual Dizziness

I.R.C.C.S. Fondazione Santa Lucia0 sites40 target enrollmentJuly 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Enrollment
40
Primary Endpoint
Changes of Dizziness Handicap Inventory (DHI) score
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The investigators will test a new rehabilitation protocol on patients with persistent postural perceptual dizziness (PPPD). The investigators hypothesize that patients with PPPD, in the absence of vestibular deficits, do not benefit from standard vestibular rehabilitation but instead need a rehabilitation that acts on visual and postural stability, through training of saccadic movements in dynamic contexts of cognitive-motor dual-task and rehabilitation of postural stability.

Detailed Description

Persistent postural-perceptual dizziness (PPPD) is a chronic functional vestibular disorder that manifests as a sensation of non-vertiginous dizziness and instability. The most common triggers of PPPD are peripheral vestibular conditions such as vestibular neuritis (VN) and benign paroxysmal positional vertigo (BPPV), although vestibular migraine, central vestibular disorders and non-vestibular conditions such as panic attacks, minor injuries traumatic brain injury and also orthostatic intolerance have been reported as precipitants of PPPD. PPPD persists after the triggering events have resolved. The diagnostic criteria for PPPD were established by the Barany Society. Once the negativity of the routine vestibular tests has been ascertained, the diagnosis is based on additional criteria such as the persistence of the symptom of dizziness for most of the time for at least 3 months, the worsening of the symptoms when standing, during active movement or passive, during exposure to moving visual stimulation or to visual stimuli with complex textures. Existing treatments (e.g., selective serotonin reuptake inhibitors, vestibular habituation) are only partially successful in PPPD. Methods. Experimental design. Single-blind randomized controlled trial. 40 individuals affected by PPPD will be recruited. The patients will be randomly divided into 2 groups and evaluated before the rehabilitation training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3). All patients will undergo 5 rehabilitation sessions supervised by a physiotherapist with experience in rehabilitation of balance disorders. The experimental group will carry out a interactive visuo-vestibular training (IVV) in order to facilitate postural visual stability and the control group will carry out a conventional vestibular rehabilitation training aimed at training the vestibular reflexes. The rehabilitation protocols (IVV and vestibular) will consist of 1 session of 40 minutes per week, for a total of 5 sessions. IVV training consists of exercises that stimulate saccadic movements during motor activities on the treadmill and walking on the treadmill blindfolded with the support and supervision of the physiotherapist.

Registry
clinicaltrials.gov
Start Date
July 30, 2023
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Responsible Party
Principal Investigator
Principal Investigator

Marco Tramontano

Head of Rehabilitation Services

I.R.C.C.S. Fondazione Santa Lucia

Eligibility Criteria

Inclusion Criteria

  • Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted

Exclusion Criteria

  • Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.

Outcomes

Primary Outcomes

Changes of Dizziness Handicap Inventory (DHI) score

Time Frame: pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3)

DHI.Questionnaire on the severity of dizziness (Dizziness Handicap Inventory, DHI). Scores range from 0 to 50; higher scores mean a worse outcome.

Secondary Outcomes

  • Changes of locomotion parameter linear acceleration measured through wearable inertial sensors(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
  • Changes of locomotion parameter angular velocities measured through wearable inertial sensors(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
  • Changes in postural oscillations(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))
  • Changes in visual dependence through rod and the disc test(pre-training (T0), immediately after the end of the training (T1), 4 weeks after the end of the training (T2) and 8 weeks after the end of the training (T3))

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