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Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03326349
Acronym
CHRONIC
Enrollment
41
Registered
2017-10-31
Start date
2017-10-17
Completion date
2019-05-07
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke, Cognitive Impairment

Keywords

computerized cognitive rehabilitation

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.

Interventions

OTHERGuttmann, NeuroPersonalTrainer

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.

OTHERIctus.online

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.

Sponsors

Josep M. Tormos Muñoz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)1 weekBRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities.
Spanish phonemic fluency test- PMR1 dayTo improve performance in phonemic fluency after receiving experimental intervention.
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo 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.
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo 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)1 dayTo 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.
Rating Scale for Attentional Behavior (RSAB)1 weekRSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Prospective and Retrospective Memory Questionnaire (PRMQ)1 weekPRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term
Conners Continuous Performance Test (CPT-II)1 dayTo improve performance in sustained attention after receiving experimental intervention.
Rey Auditory Verbal Learning Test (RAVLT)1 dayTo improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.

Secondary

MeasureTime frameDescription
Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo 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.
Stroop Color and Word test (Stroop Test)1 dayTo improve performance in inhibitory control
Trail Making Test A (TMT-A)1 dayTo improve performance in visual attention
Trail Making Test B (TMT-B)1 dayTo improve performance in task-switching
Wisconsin Card Sorting Test (WCST)1dayTo improve performance in cognitive flexibility
Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)1 dayTo 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026