Cognitive Impairment Clinical Trial
— CHRONICOfficial title:
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
NCT number | NCT03326349 |
Other study ID # | 2016251 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 17, 2017 |
Est. completion date | May 7, 2019 |
Verified date | May 2019 |
Source | Institut Guttmann |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Institut Guttmann | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Josep M. Tormos Muñoz |
Spain,
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 |
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