Vestibular Rehabilitation and Severe Traumatic Brain Injury
- Conditions
- Severe Traumatic Brain InjuryGait Disorders, Neurologic
- Interventions
- Other: Vestibular Rehabilitation (VR)Other: Conventional Neurorehabilitation
- Registration Number
- NCT04415580
- Lead Sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vestibular Rehabilitation Group Vestibular Rehabilitation (VR) - Conventional rehabilitation Group Conventional Neurorehabilitation -
- Primary Outcome Measures
Name Time Method Dynamic Gait Index Scoring Form (DGI) Baseline to 8 weeks after the end training Change of Dynamic Gait Index Scoring Form (DGI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DGI values ranging from 0 to 24, where 0 means the worse outcome and 24 the best one.
- Secondary Outcome Measures
Name Time Method Activities-specific Balance Confidence scale (ABC) Baseline to 8 weeks after the end training Change of Activities-specific Balance Confidence scale (ABC) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. ABC values ranging from 0% to 100%, where 0% means the worse outcome and 100% the best one.
Community Balance & Mobility Scale (CB&M) Baseline to 8 weeks after the end training Change of Community Balance and Mobility Scale (CB\&M) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. CB\&M values ranging from 0 to 96, where 0 means the worse outcome and 96 the best one.
Community Integration Questionnaire (CIQ) Baseline to 8 weeks after the end training Change of Community Integration Questionnaire (CIQ) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. CIQ values ranging from 0 to 29, where 0means the worse outcome and 29 the best one.
Berg Balance Scale (BBS) Baseline to 8 weeks after the end training Change of Berg Balance Scale (BBS) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. BBS values ranging from 0 to 56, where 0 means the worse outcome and 56 the best one
Dizziness Handicap Inventory (DHI) Baseline to 8 weeks after the end training Dizziness Handicap Inventory (DHI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DHI values ranging from 0 to 100, where 100 means the worse outcome and 0 the best one.
Instrumental Assessment Baseline to 8 weeks after the end training Postural and gait functional assessment performed using inertial motion capture systems (Opal, APDM Inc., Portland, Oregon, USA, portable devices controlling 6 inertial/magnetic measurement units providing 3D orientation and kinematic). The assessments were performed at the baseline, 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training
Trial Locations
- Locations (2)
Marco Tramontano
🇮🇹Roma, Rm, Italy
Santa Lucia Foundation I.R.C.C.S.
🇮🇹Roma, Rm, Italy