Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Not Applicable

Completed

• Conditions: Chronic Stroke; Cognitive Impairment

• Registration Number: NCT03326349
• Lead Sponsor: Josep M. Tormos Muñoz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-17
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Primary Completion: 2019-02-04
• Status Verified: 2019-05
• Study Completion: 2019-05-07
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Rey Auditory Verbal Learning Test (RAVLT)	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	1 day	To improve performance in phonemic fluency after receiving experimental intervention.
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	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)	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)	1 week	BRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities.
Conners Continuous Performance Test (CPT-II)	1 day	To improve performance in sustained attention after receiving experimental intervention.
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)	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)	1 week	RSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Prospective and Retrospective Memory Questionnaire (PRMQ)	1 week	PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Guttmann; 🇪🇸 Barcelona, Spain