Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Rey Auditory Verbal Learning Test (RAVLT)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Guttmann, NeuroPersonalTrainer
Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks.
Intervention: Guttmann, NeuroPersonalTrainer (Other)
Ictus.online
Itus.online 5 days per week over 6 weeks
Intervention: Ictus.online (Other)
Outcomes
Primary Outcomes
Rey Auditory Verbal Learning Test (RAVLT)
Time Frame: 1 day
To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.
Spanish phonemic fluency test- PMR
Time Frame: 1 day
To improve performance in phonemic fluency after receiving experimental intervention.
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time Frame: 1 day
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.
Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time Frame: 1 day
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.
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time Frame: 1 week
BRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities.
Conners Continuous Performance Test (CPT-II)
Time Frame: 1 day
To improve performance in sustained attention after receiving experimental intervention.
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time Frame: 1 day
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.
Rating Scale for Attentional Behavior (RSAB)
Time Frame: 1 week
RSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Prospective and Retrospective Memory Questionnaire (PRMQ)
Time Frame: 1 week
PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term
Secondary Outcomes
- Stroop Color and Word test (Stroop Test)(1 day)
- Trail Making Test B (TMT-B)(1 day)
- Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Trail Making Test A (TMT-A)(1 day)
- Wisconsin Card Sorting Test (WCST)(1day)
Investigators
Josep M. Tormos Muñoz
Research Director
Institut Guttmann