Vestibular Rehabilitation and Severe Traumatic Brain Injury

NCT ID: NCT04415580

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-06-21

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.

Conditions

Severe Traumatic Brain Injury; Gait Disorders, Neurologic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vestibular Rehabilitation Group

Group Type: EXPERIMENTAL

Vestibular Rehabilitation (VR)

Intervention Type: OTHER

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).

Conventional rehabilitation Group

Group Type: ACTIVE_COMPARATOR

Conventional Neurorehabilitation

Intervention Type: OTHER

muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training

Interventions

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).

Intervention Type: OTHER

Conventional Neurorehabilitation

muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Marco Tramontano

head of rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marco Tramontano

Roma, Rm, Italy

Santa Lucia Foundation I.R.C.C.S.

Roma, Rm, Italy

Countries

Italy

Other Identifiers

FSLCE/PROG.700

Identifier Type: -

Identifier Source: org_study_id