Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Cognitive Impairment Clinical Trial

— CHRONIC  

Official title:

Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326349
• Other study ID #: 2016251
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: May 7, 2019

Study information

• Verified date: May 2019
• Source: Institut Guttmann
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 7, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stroke
• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

Other:
• Guttmann, 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.
• Ictus.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.

Locations

Country	Name	City	State
Spain	Institut Guttmann	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Josep M. Tormos Muñoz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Continuous Performance Test (CPT-II)	To improve performance in sustained attention after receiving experimental intervention.	1 day
Primary	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
Primary	Spanish phonemic fluency test- PMR	To improve performance in phonemic fluency after receiving experimental intervention.	1 day
Primary	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
Primary	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
Primary	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
Primary	Rating Scale for Attentional Behavior (RSAB)	RSAB comprises 14 items aimed to identify attentional difficulties on daily routines	1 week
Primary	Prospective and Retrospective Memory Questionnaire (PRMQ)	PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term	1 week
Primary	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	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
Secondary	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
Secondary	Stroop Color and Word test (Stroop Test)	To improve performance in inhibitory control	1 day
Secondary	Trail Making Test A (TMT-A)	To improve performance in visual attention	1 day
Secondary	Trail Making Test B (TMT-B)	To improve performance in task-switching	1 day
Secondary	Wisconsin Card Sorting Test (WCST)	To improve performance in cognitive flexibility	1day