Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke

NCT ID: NCT03326349

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2019-05-07

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.

Conditions

Chronic Stroke; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Guttmann, NeuroPersonalTrainer

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

Group Type: EXPERIMENTAL

Guttmann, NeuroPersonalTrainer

Intervention Type: 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

Itus.online 5 days per week over 6 weeks

Group Type: SHAM_COMPARATOR

Ictus.online

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Josep M. Tormos Muñoz

OTHER

Sponsor Role: lead

Responsible Party

Josep M. Tormos Muñoz

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Institut Guttmann

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35349186 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29566766 (View on PubMed)

Other Identifiers

2016251

Identifier Type: -

Identifier Source: org_study_id