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New Rehabilitation Protocol for Patients With PPPD

Primary Purpose

Rehabilitation, Balance, Vestibular Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interactive Visuo-Vestibular training
Vestibular rehabilitation training
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Interactive Visuo-Vestibular training

    Vestibular rehabilitation training

    Arm Description

    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.

    The conventional vestibular rehabilitation training will train the vestibular reflexes. Patients will perform 5 sessions, 1 session per week.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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: 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; the Fukuda Stepping Test. 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.
    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: 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; the Fukuda Stepping Test. 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.
    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.
    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.

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    July 12, 2023
    Sponsor
    I.R.C.C.S. Fondazione Santa Lucia
    Collaborators
    Iole Indovina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05831618
    Brief Title
    New Rehabilitation Protocol for Patients With PPPD
    Official Title
    New Rehabilitation Protocol for Patients With Persistent Postural Perceptual Dizziness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    I.R.C.C.S. Fondazione Santa Lucia
    Collaborators
    Iole Indovina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rehabilitation, Balance, Vestibular Disorder, Dizziness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interactive Visuo-Vestibular training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Vestibular rehabilitation training
    Arm Type
    Active Comparator
    Arm Description
    The conventional vestibular rehabilitation training will train the vestibular reflexes. Patients will perform 5 sessions, 1 session per week.
    Intervention Type
    Other
    Intervention Name(s)
    Interactive Visuo-Vestibular training
    Intervention Description
    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
    Intervention Name(s)
    Vestibular rehabilitation training
    Intervention Description
    Dynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group
    Primary Outcome Measure Information:
    Title
    Changes of Dizziness Handicap Inventory (DHI) score
    Description
    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 Outcome Measure Information:
    Title
    Changes of locomotion parameter linear acceleration measured through wearable inertial sensors
    Description
    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: 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; the Fukuda Stepping Test. 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)
    Title
    Changes of locomotion parameter angular velocities measured through wearable inertial sensors
    Description
    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: 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; the Fukuda Stepping Test. 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)
    Title
    Changes in visual dependence through rod and the disc test
    Description
    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)
    Title
    Changes in postural oscillations
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    New Rehabilitation Protocol for Patients With PPPD

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