NCT04415580

Vestibular Rehabilitation and Severe Traumatic Brain Injury

Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: I.R.C.C.S. Fondazione Santa Lucia · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Traumatic Brain Injury
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
OTHER	Vestibular Rehabilitation (VR)	VR consisted of two types of exercises, i.e., those for gaze stability and those for postural stability * Gaze stability exercises The patients will perform the exercises while holding their gaze on a firm target (VORx1) during active horizontal and vertical head movements (one minute for each axis). * Postural stability exercises March in Place Each patient will ask to get on a foam cushion of 10 cm in height and then will blindfold. Treadmill Training As preparation for training, all subjects underwent a 1-minute walk on treadmill with open eyes using preferred walking speed. Immediately after preparation, patients will blindfold and will ask to walk on treadmill without support of hands for 4 minutes. 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).
OTHER	Conventional Neurorehabilitation	muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-02-26
• Completion: 2021-06-21
• First posted: 2020-06-04
• Last updated: 2021-06-22

Locations

2 sites across 1 country: Italy