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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vestibular Rehabilitation Group | Experimental |
| |
| Conventional rehabilitation Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular Rehabilitation (VR) | Other | VR consisted of two types of exercises, i.e., those for gaze stability and those for postural stability
When patients made the mistake of changing direction, the physiotherapist help them to keep the right position using verbal cues (e.g., you are turning left or right). |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Gait Index Scoring Form (DGI) | 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. | Baseline to 8 weeks after the end training |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale (BBS) | 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 | Baseline to 8 weeks after the end training |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marco Tramontano | Roma | Rm | 00179 | Italy | ||
| Santa Lucia Foundation I.R.C.C.S. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Conventional Neurorehabilitation | Other | muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training |
|
| Community Balance & Mobility Scale (CB&M) |
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. |
| Baseline to 8 weeks after the end training |
| Activities-specific Balance Confidence scale (ABC) | 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. | Baseline to 8 weeks after the end training |
| Community Integration Questionnaire (CIQ) | 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. | Baseline to 8 weeks after the end training |
| Dizziness Handicap Inventory (DHI) | 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. | Baseline to 8 weeks after the end training |
| Instrumental Assessment | 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 | Baseline to 8 weeks after the end training |
| Roma |
| Rm |
| 00179 |
| Italy |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |