Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke (CHRONIC)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Chronic Stroke
• Intervention / Treatment: Other: Guttmann, NeuroPersonalTrainer; Other: Ictus.online

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08916
    • Institut Guttmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guttmann, NeuroPersonalTrainer; Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks.	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.
Sham Comparator: Ictus.online; Itus.online 5 days per week over 6 weeks	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conners Continuous Performance Test (CPT-II)	To improve performance in sustained attention after receiving experimental intervention.	1 day
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
Spanish phonemic fluency test- PMR	To improve performance in phonemic fluency after receiving experimental intervention.	1 day
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
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
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
Rating Scale for Attentional Behavior (RSAB)	RSAB comprises 14 items aimed to identify attentional difficulties on daily routines	1 week
Prospective and Retrospective Memory Questionnaire (PRMQ)	PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term	1 week
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Stroop Color and Word test (Stroop Test)	To improve performance in inhibitory control	1 day
Trail Making Test A (TMT-A)	To improve performance in visual attention	1 day
Trail Making Test B (TMT-B)	To improve performance in task-switching	1 day
Wisconsin Card Sorting Test (WCST)	To improve performance in cognitive flexibility	1day

Collaborators and Investigators

• Sponsor: Josep M. Tormos Muñoz

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: computerized cognitive rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016251

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No