Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of Guttmann NeuroPersonalTrainer (GNPT), a tele-rehabilitation platform developed as a tool for the cognitive rehabilitation of chronic stroke patients. All patients will receive this treatment but in different order: half will receive GNPT and the other half will receive sham cognitive training; after a washout period of three months, crossover will occur and participants from the GNPT condition will receive sham cognitive training, while participants originally from the control intervention will receive GNPT.

Official Title
-----------------
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Conditions
-----------------
Chronic Stroke, Cognitive Impairment

Intervention / Treatment
-----------------
* Other: Guttmann, NeuroPersonalTrainer
* Other: Ictus.online


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be over 18 years old, to have been diagnosed with stroke an occurrence of the injury of 12 month period ore more (chronic stage) cognitive impairment confirmed by pre-intervention neuropsychological assessment Exclusion Criteria: diagnosis of language deficits or aphasia motor impairment concerning upper limbs that may incapacitate them for the use of the computer severe alteration of the visual field or perceptual problems health status that may require further intervention or admission to a medical center during the study; neurological or psychiatric history substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guttmann, NeuroPersonalTrainer<br>Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks. | Other: Guttmann, NeuroPersonalTrainer<br>* Guttmann NeuroPersonalTrainer (GNPT) is a telerehabilitation platform. GNPT consists of a set of computerized cognitive exercises covering different cognitive functions and subfunctions. Every task has been specifically based on cognitive paradigms to address specific cognitive subfunction. The rehabilitation process starts by assigning a patient to a therapist responsible for the treatment. The therapist has then to perform the initial neuropsychological assessment, consisting of a set of validated tests used to attention, memory and executive functions prior to the treatment. The results of these tests will be stored in GNPT system. Then, the cognitive profile is calculated using these results, and taking into account the patient's age and study level. Using this profile, the program assigns a set of computerized tasks to a certain day, configuring the input parameters of each task in order to personalize treatments.<br>|
| Sham Comparator: Ictus.online<br>Itus.online 5 days per week over 6 weeks | Other: Ictus.online<br>* An online domain which provides a daily session of one hour of duration. Each session consists of four ten-minute videos. After each video, the participant must complete a three-question quiz about the contents of the video (for example, What animal appears in in the video?). The difficulty level is minimal, and does not vary depending on the execution of the participant.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conners Continuous Performance Test (CPT-II) | To improve performance in sustained attention after receiving experimental intervention. | 1 day | 
| Rey Auditory Verbal Learning Test (RAVLT) | To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75. | 1 day | 
| Spanish phonemic fluency test- PMR | To improve performance in phonemic fluency after receiving experimental intervention. | 1 day | 
| Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) | To improve performance in span of immediate verbal recall after receiving experimental intervention. This subtest has a puntuation range from 2 to 9, where higher values are considered to be a better outcome. | 1 day | 
| Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) | To improve performance in working memory after receiving experimental intervention. This subtest has a puntuation range from 2 to 8, where higher values are considered to be a better outcome. | 1 day | 
| Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) | To improve performance in working memory after receiving experimental intervention. This subtest has a puntation range from 1 to 21, where higher values are considered to be a better outcome. | 1 day | 
| Rating Scale for Attentional Behavior (RSAB) | RSAB comprises 14 items aimed to identify attentional difficulties on daily routines | 1 week | 
| Prospective and Retrospective Memory Questionnaire (PRMQ) | PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term | 1 week | 
| Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) | BRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) | To improve performance in speed of processing. This subtest has a puntuation range from 1 to 133, where higher values are considered to be a better outcome. | 1 day | 
| Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) | To improve performance in visuoconstruction and planning. This subtest has a puntuation range from 1 to 68, where higher values are considered to be a better outcome. | 1 day | 
| Stroop Color and Word test (Stroop Test) | To improve performance in inhibitory control | 1 day | 
| Trail Making Test A (TMT-A) | To improve performance in visual attention | 1 day | 
| Trail Making Test B (TMT-B) | To improve performance in task-switching | 1 day | 
| Wisconsin Card Sorting Test (WCST) | To improve performance in cognitive flexibility | 1day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
computerized cognitive rehabilitation