- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402360
Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandro Iannaccone
- Phone Number: 0039 0226435734
- Email: iannaccone.sandro@hsr.it
Study Locations
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-
MI
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Milan, MI, Italy, 20132
- Ircss Ospedale San Raffaele
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Contact:
- Sandro Iannaccone
- Phone Number: 0039 0226435734
- Email: iannaccone.sandro@hsr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality rehabilitation group
The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.
|
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 |
Active Comparator: Control group
The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Action Research Arm Test (ARAT)
Time Frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
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)
|
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)
|
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)
|
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)
|
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)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Resting state functional MRI (fMRI)
Time Frame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR-ABI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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