New Rehabilitation Protocol for Patients With PPPD

NCT05831618 | Not Yet Recruiting

• 1 other identifier: FSL/CE/2024_021
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rehabilitation; Balance; Vestibular Disorder; Dizziness

Outcome Measures

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.

  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

  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

  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

  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

  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)

Study Arms (2)

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.

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.

Other: Vestibular rehabilitation training

Interventions

Interactive Visuo-Vestibular training 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.

Interactive Visuo-Vestibular training

Vestibular rehabilitation training OTHER

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

Vestibular rehabilitation training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted

You may not qualify if:

• Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• Iole Indovina: collaborator

MeSH Terms

Conditions

Vestibular Diseases; Dizziness

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Services

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 26, 2023
• Study Start: July 30, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share