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Vestibular Rehabilitation and Severe Traumatic Brain Injury

Primary Purpose

Severe Traumatic Brain Injury, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vestibular Rehabilitation (VR)
Conventional Neurorehabilitation
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Traumatic Brain Injury

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marco Tramontano
  • Santa Lucia Foundation I.R.C.C.S.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vestibular Rehabilitation Group

Conventional rehabilitation Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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

Full Information

First Posted
May 31, 2020
Last Updated
June 21, 2021
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT04415580
Brief Title
Vestibular Rehabilitation and Severe Traumatic Brain Injury
Official Title
Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury, Gait Disorders, Neurologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Rehabilitation Group
Arm Type
Experimental
Arm Title
Conventional rehabilitation Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Vestibular Rehabilitation (VR)
Intervention Description
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
Intervention Name(s)
Conventional Neurorehabilitation
Intervention Description
muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training
Primary Outcome Measure Information:
Title
Dynamic Gait Index Scoring Form (DGI)
Description
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.
Time Frame
Baseline to 8 weeks after the end training
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
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
Time Frame
Baseline to 8 weeks after the end training
Title
Community Balance & Mobility Scale (CB&M)
Description
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.
Time Frame
Baseline to 8 weeks after the end training
Title
Activities-specific Balance Confidence scale (ABC)
Description
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.
Time Frame
Baseline to 8 weeks after the end training
Title
Community Integration Questionnaire (CIQ)
Description
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.
Time Frame
Baseline to 8 weeks after the end training
Title
Dizziness Handicap Inventory (DHI)
Description
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.
Time Frame
Baseline to 8 weeks after the end training
Title
Instrumental Assessment
Description
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
Time Frame
Baseline to 8 weeks after the end training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Marco Tramontano
City
Roma
State/Province
Rm
ZIP/Postal Code
00179
Country
Italy
Facility Name
Santa Lucia Foundation I.R.C.C.S.
City
Roma
State/Province
Rm
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

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Vestibular Rehabilitation and Severe Traumatic Brain Injury

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