Smart Autonomous Neuro-Rehabilitation System

Study Overview
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Brief Summary
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Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements.

Conditions
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Cognition Disorders, Cognitive Deficits

Intervention / Treatment
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* Behavioral: Cognitive rehabilitation training with RGS in the clinic
* Behavioral: Passive/conventional cognitive training at home.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score on Mini-Mental State Examination between 18 - 24 Score on Montreal Cognitive Assessment less than 26 More than 2 points in upper limb motor scale MRC Sufficient cognitive ability to understand and follow the experimental instructions Exclusion Criteria: Score on Mini-Mental State Examination below 18 or above 24 Score on Montreal Cognitive Assessment of 26 or above Below 2 point in upper limb motor scale MRC Hemianopia Cognitive capacity that prohibits the execution of the experiment Severe impairment like spasticity, aphasia or apraxia, major pain or other neuromuscular impairments or dependent on use of orthopedic devices that would interfere with the correct execution of understanding of the experiment History of serious mental-health problems in acute or subacute phase Patients that do not give their consent to participate in the study

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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: Cognitive rehabilitation group<br>Cognitive rehabilitation training with RGS in the clinic. | Behavioral: Cognitive rehabilitation training with RGS in the clinic<br>* Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).<br>|
| Active Comparator: Passive control group<br>Passive/conventional cognitive training at home. | Behavioral: Passive/conventional cognitive training at home.<br>* Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up | Measurement of attention | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Corsi block tapping test from baseline to end of treatment and to follow-up | Measurement of attention | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up | Measurement of attention | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up | Measurement of episodic memory | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up | Measurement of working memory | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up | Measurement of working memory | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up | Measurement of executive functioning | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up | Measurement of set-shifting | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up | Measurement of processing speed | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Star Cancellation test from baseline to end of treatment and to follow-up | Measurement of spatial neglect | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up | Measurement of global cognitive ability | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up | Measurement of global health status | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Barthel Index from baseline to end of treatment and to follow-up | Measurement of independent functioning and mobility in activities of daily living | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 
| Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up | Measurement of motor recovery after stroke | Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive rehabilitation, memory, attention, spatial neglect, executive dysfunctioning