Acquired Brain InjuryNCT03402360
Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
A study testing Virtual Reality rehabilitation group in people with Acquired Brain Injury, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Virtual Reality rehabilitation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2019to 30 Apr 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acquired Brain Injury within 1 month before the recruitment;
- Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);
- Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.
Who cannot join
- Denial of informed consent;
- Visual deficits that interfere with the virtual reality rehabilitation;
- Score under 18 at the Mini Mental State Examination;
- Severe orthopedic deficit;
- Patients with pace maker;
- Patients with contraindication to undergo magnetic resonance;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCSS Ospedale San Raffaele
Milan, MI, 20132
Sandro Iannaccone, 0226435734 ext. 0039, iannaccone.sandro@hsr.it
About this study
Official title: Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.
- Conditions
- Acquired Brain Injury
- Being tested
- Virtual Reality rehabilitation group, Control group rehabilitation
- Keywords
- Virtual Reality, Rehabilitation, Acquired Brain Injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality rehabilitation groupOther
Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks).
1 hour: conventional physiotherapy
1 hour: virtual reality upper extremity motor rehabilitation
1 hour: virtual reality neurocognitive training
Control group rehabilitationOther
Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks).
1 hour: conventional physiotherapy
1 hour: upper extremity motor rehabilitation
1 hour: neurocognitive training
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality rehabilitation group | Experimental | The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training. Receives: Other: Virtual Reality rehabilitation group |
| Control group | Active comparator | The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off. Receives: Other: Control group rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Upper Extremity (FMUE)
Items are scored on a 3-point ordinal scale
0 = cannot perform; 1 = performs partially; 2 = performs fully.
Maximum Score = 66 points
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary outcomes (6)
Change in Action Research Arm Test (ARAT)
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Functional Independence Measures (FIM)
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Mini Mental State Examination (MMSE)
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Montreal Cognitive Assessment (MoCA)
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Beck Depression Inventory (BDI)
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in 36-Item Short Form Survey (SF-36)
Measured: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Nov 2019 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Iannaccone, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402360
- Sponsor's protocol ID
- VR-ABI
- Status last verified
- Jun 2019
- First submitted
- 9 Jan 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03402360
- Acronym / sponsor ID
- VR-ABI
- Conditions
- Acquired Brain Injury
- Keywords
- Virtual Reality, Rehabilitation, Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 18 Jan 2018 (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.
The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality rehabilitation group | Experimental | Other: Virtual Reality rehabilitation groupThe Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training. |
| Control group | Active comparator | Other: Control group rehabilitationThe Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acquired Brain Injury within 1 month before the recruitment;
- Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);
- Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.
Key exclusion criteria (7 listed)
- Denial of informed consent;
- Visual deficits that interfere with the virtual reality rehabilitation;
- Score under 18 at the Mini Mental State Examination;
- Severe orthopedic deficit;
- Patients with pace maker;
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 |
|---|---|---|
| Virtual Reality rehabilitation groupThree hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: virtual reality upper extremity motor rehabilitation 1 hour: virtual reality neurocognitive training | Other | Virtual Reality rehabilitation group |
| Control group rehabilitationThree hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: upper extremity motor rehabilitation 1 hour: neurocognitive training | Other | Control group |
Primary outcome
Change in Fugl-Meyer Upper Extremity (FMUE)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Items are scored on a 3-point ordinal scale 0 = cannot perform; 1 = performs partially; 2 = performs fully. Maximum Score = 66 points
6 secondary outcomes
Change in Action Research Arm Test (ARAT)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Functional Independence Measures (FIM)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Mini Mental State Examination (MMSE)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Montreal Cognitive Assessment (MoCA)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in Beck Depression Inventory (BDI)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Change in 36-Item Short Form Survey (SF-36)
Time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality rehabilitation group in people with Acquired Brain Injury, run by IRCCS San Raffaele at 1 site 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandro Iannaccone (0226435734 ext. 0039, iannaccone.sandro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Upper Extremity (FMUE) (time frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)). 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 17 Jun 2019.