NCT03326349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

October 26, 2017

Last Update Submit

May 17, 2019

Conditions

Chronic StrokeCognitive Impairment

Keywords

computerized cognitive rehabilitation

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (6)

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

    1 day

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

    1 day

  • Stroop Color and Word test (Stroop Test)

    1 day

  • Trail Making Test A (TMT-A)

    1 day

  • Trail Making Test B (TMT-B)

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Guttmann, NeuroPersonalTrainer

EXPERIMENTAL

Guttmann NeuroPersonalTrainer (GNPT) 5 days per week over 6 weeks.

Other: Guttmann, NeuroPersonalTrainer

Ictus.online

SHAM COMPARATOR

Itus.online 5 days per week over 6 weeks

Other: Ictus.online

Interventions

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.

Guttmann, NeuroPersonalTrainer
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.

Ictus.online

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Guttmann

Barcelona, 08916, Spain

Location

Related Publications (2)

  • 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.

    PMID: 35349186DERIVED

  • 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.

    PMID: 29566766DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

October 26, 2017

First Posted

October 31, 2017

Study Start

October 17, 2017

Primary Completion

February 4, 2019

Study Completion

May 7, 2019

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

ES(1)