Clinical trial NCT03326349: Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Official title: Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Cognitive Impairment
Keywords: computerized cognitive rehabilitation
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Conners Continuous Performance Test (CPT-II)
timeFrame: 1 day
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 1 day
measure: Spanish phonemic fluency test- PMR
timeFrame: 1 day
measure: Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Rating Scale for Attentional Behavior (RSAB)
timeFrame: 1 week
measure: Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: 1 week
measure: Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
timeFrame: 1 week
Secondary outcomes:
measure: Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: 1 day
measure: Stroop Color and Word test (Stroop Test)
timeFrame: 1 day
measure: Trail Making Test A (TMT-A)
timeFrame: 1 day
measure: Trail Making Test B (TMT-B)
timeFrame: 1 day
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 1day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Guttmann
Study officials:
References:
citation: Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
citation: Gil-Pages M, Solana J, Sanchez-Carrion R, Tormos JM, Ensenat-Cantallops A, Garcia-Molina A. A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial. Trials. 2018 Mar 22;19(1):191. doi: 10.1186/s13063-018-2577-8.