Chronic StrokeCHRONICNCT03326349
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
A study testing Guttmann, NeuroPersonalTrainer and Ictus.online in people with Chronic Stroke and Cognitive Impairment, run by Josep M. Tormos Muñoz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Stroke, Cognitive Impairment
- What is being tested?
- Guttmann, NeuroPersonalTrainer and Ictus.online
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 17 Oct 2017to 7 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Stroke, Cognitive Impairment
- Being tested
- Guttmann, NeuroPersonalTrainer, Ictus.online
- Keywords
- computerized cognitive rehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guttmann, NeuroPersonalTrainerOther
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.onlineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Guttmann, NeuroPersonalTrainer | Experimental | Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks. Receives: Other: Guttmann, NeuroPersonalTrainer |
| Ictus.online | Sham comparator | Itus.online 5 days per week over 6 weeks Receives: Other: Ictus.online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Continuous Performance Test (CPT-II)
To improve performance in sustained attention after receiving experimental intervention.
Measured: 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.
Measured: 1 day
Spanish phonemic fluency test- PMR
To improve performance in phonemic fluency after receiving experimental intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Rating Scale for Attentional Behavior (RSAB)
RSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Measured: 1 week
Prospective and Retrospective Memory Questionnaire (PRMQ)
PRMQ includes 16 items designed to evaluate prospective and retrospective memory in short- and long-term
Measured: 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.
Measured: 1 week
Secondary outcomes (6)
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.
Measured: 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.
Measured: 1 day
Stroop Color and Word test (Stroop Test)
To improve performance in inhibitory control
Measured: 1 day
Trail Making Test A (TMT-A)
To improve performance in visual attention
Measured: 1 day
Trail Making Test B (TMT-B)
To improve performance in task-switching
Measured: 1 day
Wisconsin Card Sorting Test (WCST)
To improve performance in cognitive flexibility
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start17 Oct 2017
- Primary completion4 Feb 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josep M. Tormos Muñoz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep M. Tormos Muñoz, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326349
- Sponsor's protocol ID
- 2016251
- Acronym
- CHRONIC
- Status last verified
- May 2019
- First submitted
- 26 Oct 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35349186Gil-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.
PubMed 29566766
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
- ClinicalTrials.gov ID
- NCT03326349
- Acronym / sponsor ID
- CHRONIC / 2016251
- Conditions
- Chronic Stroke, Cognitive Impairment
- Keywords
- computerized cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Josep M. Tormos MuñozUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guttmann, NeuroPersonalTrainer | Experimental | Other: Guttmann, NeuroPersonalTrainerGuttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks. |
| Ictus.online | Sham comparator | Other: Ictus.onlineItus.online 5 days per week over 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guttmann, NeuroPersonalTrainerGuttmann 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. | Other | Guttmann, NeuroPersonalTrainer |
| Ictus.onlineAn 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. | Other | Ictus.online |
Primary outcome
Conners Continuous Performance Test (CPT-II)
Time frame: 1 day
To improve performance in sustained attention after receiving experimental intervention.
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 1 day
To improve performance in short-term, long-term and recognition. This test has puntuation range from 0 to 75.
Spanish phonemic fluency test- PMR
Time frame: 1 day
To improve performance in phonemic fluency after receiving experimental intervention.
Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
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)
Time frame: 1 day
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)
Time frame: 1 day
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)
Time frame: 1 week
RSAB comprises 14 items aimed to identify attentional difficulties on daily routines
Prospective and Retrospective Memory Questionnaire (PRMQ)
Time frame: 1 week
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)
Time frame: 1 week
BRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities.
6 secondary outcomes
Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: 1 day
Stroop Color and Word test (Stroop Test)
Time frame: 1 day
Trail Making Test A (TMT-A)
Time frame: 1 day
Trail Making Test B (TMT-B)
Time frame: 1 day
Wisconsin Card Sorting Test (WCST)
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 35349186Gibson 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.
- Derived from this study: PubMed 29566766Gil-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guttmann, NeuroPersonalTrainer and Ictus.online in people with Chronic Stroke and Cognitive Impairment, run by Josep M. Tormos Muñoz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners Continuous Performance Test (CPT-II) (time frame: 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.