Vestibular Rehabilitation and Severe Traumatic Brain Injury

I.R.C.C.S. Fondazione Santa Lucia

Status: Completed

Conditions: Gait Disorders, Neurologic; Severe Traumatic Brain Injury

Treatments: Other: Vestibular Rehabilitation (VR); Other: Conventional Neurorehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04415580

FSLCE/PROG.700

Details and patient eligibility

About

Severe brain injury (sTBI) is one of the most common causes of long-term disability and is considered the most frequent cause of mortality and serious disability in young adults in industrialized countries. It is defined as an alteration of brain function with loss of consciousness in the acute phase for at least 24 hours (Glasgow Coma Scale (GCS) <8) and it can induce a wide range of deficit, including cognitive-behavioural, motors, psychics, language, vision, coordination and balance impairments. Chronic vestibular symptoms such as dizziness and balance deficits (both static and dynamic postural instability) are present in patients with brain injury. These aspects can cause functions limitation and psychological distress, negatively impacting negatively on subjects' quality of life and social reintegration and are considered unfavourable prognostic factors of the recovery process. The literature supports the use of vestibular rehabilitation techniques in patients with mild and moderate brain injury, however, to date, no studies investigated the effect of vestibular rehabilitation in sTBI patients. The main aim of this randomized controlled trail is to verify the effect of a personalized vestibular training on balance and gait disorders in sTBI patients.

Enrollment: 30 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 15 and 65 years;
• Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
• Level of cognitive functioning (LCF) ≥7;
• Ability to understand verbal commands and the informed consent.
• Presence of static and dynamic balance impairments.
• Functional Ambulation Classification (FAC) ≥ 3

Exclusion criteria

• Glasgow coma scale (GCS) score >8
• Level of cognitive functioning (LCF) <7
• Inability to understand verbal commands
• Absence of static and dynamic balance impairments.
• Functional Ambulation Classification (FAC) < 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Vestibular Rehabilitation Group

Experimental group

Treatment:

Other: Vestibular Rehabilitation (VR)

Conventional rehabilitation Group

Active Comparator group

Treatment:

Other: Conventional Neurorehabilitation