Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke (CHRONIC)
Primary Purpose
Chronic Stroke, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Guttmann, NeuroPersonalTrainer
Ictus.online
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke focused on measuring computerized cognitive rehabilitation
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.
Sites / Locations
- Institut Guttmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Guttmann, NeuroPersonalTrainer
Ictus.online
Arm Description
Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks.
Itus.online 5 days per week over 6 weeks
Outcomes
Primary Outcome Measures
Conners Continuous Performance Test (CPT-II)
To improve performance in sustained attention after receiving experimental intervention.
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.
Spanish phonemic fluency test- PMR
To improve performance in phonemic fluency after receiving experimental intervention.
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.
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.
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.
Rating Scale for Attentional Behavior (RSAB)
RSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Prospective and Retrospective Memory Questionnaire (PRMQ)
PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term
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.
Secondary Outcome Measures
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.
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.
Stroop Color and Word test (Stroop Test)
To improve performance in inhibitory control
Trail Making Test A (TMT-A)
To improve performance in visual attention
Trail Making Test B (TMT-B)
To improve performance in task-switching
Wisconsin Card Sorting Test (WCST)
To improve performance in cognitive flexibility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03326349
Brief Title
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Acronym
CHRONIC
Official Title
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josep M. Tormos Muñoz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Cognitive Impairment
Keywords
computerized cognitive rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guttmann, NeuroPersonalTrainer
Arm Type
Experimental
Arm Description
Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks.
Arm Title
Ictus.online
Arm Type
Sham Comparator
Arm Description
Itus.online 5 days per week over 6 weeks
Intervention Type
Other
Intervention Name(s)
Guttmann, NeuroPersonalTrainer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ictus.online
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conners Continuous Performance Test (CPT-II)
Description
To improve performance in sustained attention after receiving experimental intervention.
Time Frame
1 day
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.
Time Frame
1 day
Title
Spanish phonemic fluency test- PMR
Description
To improve performance in phonemic fluency after receiving experimental intervention.
Time Frame
1 day
Title
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Rating Scale for Attentional Behavior (RSAB)
Description
RSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Time Frame
1 week
Title
Prospective and Retrospective Memory Questionnaire (PRMQ)
Description
PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term
Time Frame
1 week
Title
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Description
BRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
1 day
Title
Stroop Color and Word test (Stroop Test)
Description
To improve performance in inhibitory control
Time Frame
1 day
Title
Trail Making Test A (TMT-A)
Description
To improve performance in visual attention
Time Frame
1 day
Title
Trail Making Test B (TMT-B)
Description
To improve performance in task-switching
Time Frame
1 day
Title
Wisconsin Card Sorting Test (WCST)
Description
To improve performance in cognitive flexibility
Time Frame
1day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institut Guttmann
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35349186
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.
Results Reference
derived
PubMed Identifier
29566766
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.
Results Reference
derived
Learn more about this trial
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
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