An interventional study of Interactive Visuo-Vestibular training and Vestibular rehabilitation training in Rehabilitation, Balance and Vestibular Disorder, sponsored by I.R.C.C.S. Fondazione Santa Lucia. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by I.R.C.C.S. Fondazione Santa Lucia · Not applicable, Interventional, and Treatment
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.
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.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's planned enrollment of 40 is below the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →I.R.C.C.S. Fondazione Santa Lucia is the lead sponsor of 56 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Interactive Visuo-Vestibular training
The conventional vestibular rehabilitation training will train the vestibular reflexes. Patients will perform 5 sessions, 1 session per week.
Other: Vestibular rehabilitation 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.
Dynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group
Changes of Dizziness Handicap Inventory (DHI) score
DHI.Questionnaire on the severity of dizziness (Dizziness Handicap Inventory, DHI). Scores range from 0 to 50; higher scores mean a worse outcome.
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)
Changes of locomotion parameter linear acceleration measured through wearable inertial sensors
Five wireless wearable inertial sensors will be used. Each inertial sensor measures linear accelerations (m/s\^2) along its three axes. (L4-L5) of the wrists and shins. During 4 specific tasks, the accelerations of the body segments of interest will be measured. The motor tasks will be the following: 1. the 10 Meter Walk Test, a test commonly used to measure walking speed in which the patient is asked to walk 3 times at preferred speed along a 10-metre path; 2. the Fukuda Stepping Test. 3. the walk following a path in the shape of an 8, drawn on the floor and with a diameter of each circle of 1.66 m.
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)
Changes of locomotion parameter angular velocities measured through wearable inertial sensors
Five wireless wearable inertial sensors will be used. A triaxial gyroscope will measure angular velocities (rad/s) around three axes. (L4-L5) of the wrists and shins. During 4 specific tasks, angular velocities of the body segments of interest will be measured. The motor tasks will be the following: 1. the 10 Meter Walk Test, a test commonly used to measure walking speed in which the patient is asked to walk 3 times at preferred speed along a 10-metre path; 2. the Fukuda Stepping Test. 3. the walk following a path in the shape of an 8, drawn on the floor and with a diameter of each circle of 1.66 m.
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)
Changes in visual dependence through rod and the disc test
Rod and Disk test. In a darkened room (to eliminate external visual cues), participants will be presented with a visual stimulus on a computer monitor consisting of a bar in the center of a disk and a background of rotating disks. Participants will have to align the bar to the Earth vertical, using the arrows on the computer keyboard. Angular realignment errors with respect to the Earth vertical will be measured.
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)
Changes in postural oscillations
Measurement of postural oscillations. Through the "Sway" application (https://www.swaymedical.com/), installed on a mobile phone held on the chest with the patient's arms folded, we will measure the personal accelerations related to the maintenance and loss of balance during standard tasks of the mCTSIB (modified clinical test of sensory interaction on balance) and mBESS (modified balance error scoring system) protocols which alternate feet aligned, leg raised, eyes closed or open, stable or foam support.
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Dec 2025, 29 months later.
Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 29 months is above that.
Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
I.R.C.C.S. Fondazione Santa Lucia