New Rehabilitation Protocol for Patients With PPPD

NCT ID: NCT05831618

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2026-12-31

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.

Conditions

Rehabilitation; Balance; Vestibular Disorder; Dizziness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interactive Visuo-Vestibular training

Interactive Visuo-Vestibular training consists of exercises that stimulate saccadic movements during motor activities on the treadmill. Furthermore, a dynamic blindfolded training will be performed with the support and supervision of the physiotherapist.

Patients will perform 5 sessions, 1 session per week.

Group Type: EXPERIMENTAL

Interactive Visuo-Vestibular training

Intervention Type: OTHER

Dynamic motor activitites aimed to enhance the visuo-vestibular interaction and the sensorial reweighting will be performed for the Interactive Visuo-Vestibular training group.

Vestibular rehabilitation training

The conventional vestibular rehabilitation training will train the vestibular reflexes.

Patients will perform 5 sessions, 1 session per week.

Group Type: ACTIVE_COMPARATOR

Vestibular rehabilitation training

Intervention Type: OTHER

Dynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group

Interventions

Interactive Visuo-Vestibular training

Dynamic motor activitites aimed to enhance the visuo-vestibular interaction and the sensorial reweighting will be performed for the Interactive Visuo-Vestibular training group.

Intervention Type: OTHER

Vestibular rehabilitation training

Dynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iole Indovina

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Marco Tramontano

Head of Rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FSL/CE/2024_021

Identifier Type: -

Identifier Source: org_study_id