Vestibular Rehabilitation and Severe Traumatic Brain Injury

NCT04415580 | Completed

• 1 other identifier: FSLCE/PROG.700
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Berg Balance Scale (BBS)

  Baseline to 8 weeks after the end training

• Community Balance & Mobility Scale (CB&M)

  Baseline to 8 weeks after the end training

• Activities-specific Balance Confidence scale (ABC)

  Baseline to 8 weeks after the end training

• Community Integration Questionnaire (CIQ)

  Baseline to 8 weeks after the end training

• Dizziness Handicap Inventory (DHI)

  Baseline to 8 weeks after the end training

Study Arms (2)

Vestibular Rehabilitation Group

EXPERIMENTAL

Other: Vestibular Rehabilitation (VR)

Conventional rehabilitation Group

ACTIVE COMPARATOR

Other: Conventional Neurorehabilitation

Interventions

Vestibular Rehabilitation (VR) 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).

Vestibular Rehabilitation Group

Conventional Neurorehabilitation OTHER

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

Conventional rehabilitation Group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (2)

Marco Tramontano

Roma, Rm, 00179, Italy

Location

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

Roma, Rm, 00179, Italy

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of rehabilitation Services

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: February 26, 2021
• Study Completion: June 21, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

IT (2)