CHRONIC: Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

Sponsor
Josep M. Tormos Muñoz (Other)
Overall Status
Completed
CT.gov ID
NCT03326349
Collaborator
(none)
41
1
2
18.6
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Guttmann, NeuroPersonalTrainer
  • Other: Ictus.online
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Actual Study Start Date :
Oct 17, 2017
Actual Primary Completion Date :
Feb 4, 2019
Actual Study Completion Date :
May 7, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Conners Continuous Performance Test (CPT-II) [1 day]

    To improve performance in sustained attention after receiving experimental intervention.

  2. Rey Auditory Verbal Learning Test (RAVLT) [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 [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) [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) [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) [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) [1 week]

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

  8. Prospective and Retrospective Memory Questionnaire (PRMQ) [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) [1 week]

    BRIEF-A includes 75 items designed to assess executive function behaviors on day-to-day activities.

Secondary Outcome Measures

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

    To improve performance in inhibitory control

  4. Trail Making Test A (TMT-A) [1 day]

    To improve performance in visual attention

  5. Trail Making Test B (TMT-B) [1 day]

    To improve performance in task-switching

  6. Wisconsin Card Sorting Test (WCST) [1day]

    To improve performance in cognitive flexibility

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Guttmann Barcelona Spain 08916

Sponsors and Collaborators

  • Josep M. Tormos Muñoz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Josep M. Tormos Muñoz, Research Director, Institut Guttmann
ClinicalTrials.gov Identifier:
NCT03326349
Other Study ID Numbers:
  • 2016251
First Posted:
Oct 31, 2017
Last Update Posted:
May 21, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Josep M. Tormos Muñoz, Research Director, Institut Guttmann
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2019