Clinical trial NCT04415580: Vestibular Rehabilitation and Severe Traumatic Brain Injury
Official title: Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Traumatic Brain Injury
Gait Disorders, Neurologic
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dynamic Gait Index Scoring Form (DGI)
timeFrame: Baseline to 8 weeks after the end training
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Baseline to 8 weeks after the end training
measure: Community Balance & Mobility Scale (CB&M)
timeFrame: Baseline to 8 weeks after the end training
measure: Activities-specific Balance Confidence scale (ABC)
timeFrame: Baseline to 8 weeks after the end training
measure: Community Integration Questionnaire (CIQ)
timeFrame: Baseline to 8 weeks after the end training
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline to 8 weeks after the end training
measure: Instrumental Assessment
timeFrame: Baseline to 8 weeks after the end training
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Marco Tramontano
state: Rm
city: Roma
country: Italy
facility: Santa Lucia Foundation I.R.C.C.S.
state: Rm
Study officials:
References: