RehabilitationNCT05831618
New Rehabilitation Protocol for Patients With PPPD
A study testing Interactive Visuo-Vestibular training and Vestibular rehabilitation training in people with Rehabilitation and Balance, run by I.R.C.C.S. Fondazione Santa Lucia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rehabilitation, Balance, Vestibular Disorder
- What is being tested?
- Interactive Visuo-Vestibular training and Vestibular rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted
Who cannot join
- Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.
About this study
Official title: New Rehabilitation Protocol for Patients With Persistent Postural Perceptual Dizziness
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.
Read the 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
- Being tested
- Interactive Visuo-Vestibular training, Vestibular rehabilitation training
- Medical subject headings
- Vestibular Diseases, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Visuo-Vestibular trainingOther
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 trainingOther
Dynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group
| Study group | Role | What they receive |
|---|---|---|
| Interactive Visuo-Vestibular training | Experimental | 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. Receives: Other: Interactive Visuo-Vestibular training |
| Vestibular rehabilitation training | Active comparator | The conventional vestibular rehabilitation training will train the vestibular reflexes.
Patients will perform 5 sessions, 1 session per week. Receives: Other: Vestibular rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start30 Jul 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- Iole Indovina
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831618
- Sponsor's protocol ID
- FSL/CE/2024_021
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Rehabilitation Protocol for Patients With Persistent Postural Perceptual Dizziness
- ClinicalTrials.gov ID
- NCT05831618
- Acronym / sponsor ID
- FSL/CE/2024_021
- Conditions
- Rehabilitation, Balance, Vestibular Disorder, Dizziness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- Iole Indovina
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Visuo-Vestibular training | Experimental | Other: Interactive Visuo-Vestibular trainingInteractive 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. |
| Vestibular rehabilitation training | Active comparator | Other: Vestibular rehabilitation trainingThe conventional vestibular rehabilitation training will train the vestibular reflexes. Patients will perform 5 sessions, 1 session per week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted
Key exclusion criteria (1 listed)
- Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Visuo-Vestibular trainingDynamic motor activitites aimed to enhance the visuo-vestibular interaction and the sensorial reweighting will be performed for the Interactive Visuo-Vestibular training group. | Other | Interactive Visuo-Vestibular training |
| Vestibular rehabilitation trainingDynamic motor activitites aimed to enhance vestibular reflexes will be performed for the vestibular rehabilitation group | Other | Vestibular rehabilitation training |
Primary outcome
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.
4 secondary outcomes
Changes of locomotion parameter linear acceleration measured through wearable inertial sensors
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
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Visuo-Vestibular training and Vestibular rehabilitation training in people with Rehabilitation and Balance, run by I.R.C.C.S. Fondazione Santa Lucia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.