Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial

Conditions
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Acquired Brain Injury

Intervention / Treatment
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* Other: Virtual Reality rehabilitation group
* Other: Control group rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality rehabilitation group<br>The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training. | Other: Virtual Reality rehabilitation group<br>* 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<br>|
| Active Comparator: Control group<br>The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off. | Other: Control group rehabilitation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Action Research Arm Test (ARAT) |  | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 
| Change in Functional Independence Measures (FIM) |  | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 
| Change in Mini Mental State Examination (MMSE) |  | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 
| Change in Montreal Cognitive Assessment (MoCA) |  | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 
| Change in Beck Depression Inventory (BDI) |  | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 
| Change in 36-Item Short Form Survey (SF-36) |  | From Baseline (T0) to 3 weeks of rehabilitation (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Rehabilitation, Acquired Brain Injury