New Rehabilitation Protocol for Patients With PPPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorI.R.C.C.S. Fondazione Santa Lucia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted
Disqualifiers
Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
Interactive Visuo-Vestibular training
Other interventionDynamic 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
Other interventionDynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Interactive Visuo-Vestibular trainingExperimental treatment 1 intervention
Group B: Vestibular rehabilitation trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
I.R.C.C.S. Fondazione Santa Lucia
Lead sponsor
Iole Indovina
Collaborator
Source ClinicalTrials.gov
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