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Completed

NCT Number: NCT03326349

Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

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.

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Key information

Conditions

Chronic Stroke Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Guttmann

Barcelona, 08916, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guttmann, NeuroPersonalTrainer

Other

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.online

Other

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 outcomes

  1. Conners Continuous Performance Test (CPT-II)

    Time frame: 1 day

    To improve performance in sustained attention after receiving experimental intervention.

  2. 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.

  3. Spanish phonemic fluency test- PMR

    Time frame: 1 day

    To improve performance in phonemic fluency after receiving experimental intervention.

  4. 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.

  5. 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.

  6. 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.

  7. Rating Scale for Attentional Behavior (RSAB)

    Time frame: 1 week

    RSAB comprises 14 items aimed to identify attentional difficulties on daily routines

  8. 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

  9. 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.

Secondary outcomes

  1. Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)

    Time frame: 1 day

    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.

  2. Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)

    Time frame: 1 day

    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.

  3. Stroop Color and Word test (Stroop Test)

    Time frame: 1 day

    To improve performance in inhibitory control

  4. Trail Making Test A (TMT-A)

    Time frame: 1 day

    To improve performance in visual attention

  5. Trail Making Test B (TMT-B)

    Time frame: 1 day

    To improve performance in task-switching

  6. Wisconsin Card Sorting Test (WCST)

    Time frame: 1day

    To improve performance in cognitive flexibility

Sponsors and collaborators

Lead sponsor

Josep M. Tormos Muñoz

Other

Registry information

Acronym: CHRONIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2017
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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