Severe Traumatic Brain InjuryNCT04415580
Vestibular Rehabilitation and Severe Traumatic Brain Injury
A study testing Vestibular Rehabilitation (VR) and Conventional Neurorehabilitation in people with Severe Traumatic Brain Injury and Gait Disorders, Neurologic, run by I.R.C.C.S. Fondazione Santa Lucia at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Severe Traumatic Brain Injury, Gait Disorders, Neurologic
- What is being tested?
- Vestibular Rehabilitation (VR) and Conventional Neurorehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2020to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Marco Tramontano
Roma, Rm, 00179
Santa Lucia Foundation I.R.C.C.S.
Roma, Rm, 00179
About this study
Official title: Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: a Randomized Controlled Trial
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.
- Being tested
- Vestibular Rehabilitation (VR), Conventional Neurorehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Conventional NeurorehabilitationOther
muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation Group | Experimental | Not described Receives: Other: Vestibular Rehabilitation (VR) |
| Conventional rehabilitation Group | Active comparator | Not described Receives: Other: Conventional Neurorehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks after the end training
Secondary outcomes (6)
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
Measured: Baseline to 8 weeks after the end 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline to 8 weeks after the end training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020
- Primary completion26 Feb 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415580
- Sponsor's protocol ID
- FSLCE/PROG.700
- Status last verified
- Jun 2021
- First submitted
- 31 May 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04415580
- Acronym / sponsor ID
- FSLCE/PROG.700
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Group | Experimental | Other: Vestibular Rehabilitation (VR) |
| Conventional rehabilitation Group | Active comparator | Other: Conventional Neurorehabilitation |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Vestibular Rehabilitation Group |
| Conventional Neurorehabilitationmuscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training | Other | Conventional rehabilitation Group |
Primary outcome
Dynamic Gait Index Scoring Form (DGI)
Time frame: Baseline to 8 weeks after the end training
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.
6 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline to 8 weeks after the end training
Community Balance & Mobility Scale (CB&M)
Time frame: Baseline to 8 weeks after the end training
Activities-specific Balance Confidence scale (ABC)
Time frame: Baseline to 8 weeks after the end training
Community Integration Questionnaire (CIQ)
Time frame: Baseline to 8 weeks after the end training
Dizziness Handicap Inventory (DHI)
Time frame: Baseline to 8 weeks after the end training
Instrumental Assessment
Time frame: Baseline to 8 weeks after the end training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation (VR) and Conventional Neurorehabilitation in people with Severe Traumatic Brain Injury and Gait Disorders, Neurologic, run by I.R.C.C.S. Fondazione Santa Lucia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index Scoring Form (DGI) (time frame: Baseline to 8 weeks after the end training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.