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Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

Primary Purpose

Stroke, Cognitive Training

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Tablet-based CT
Paper-and-pencil CT group
Sponsored by
Universidade da Madeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stroke diagnosis; Maximum age: 75 years old; Education: at least three years of formal education; Relatively preserved language abilities (expressive and receptive language); Residing in the community; Availability to go to the hospital 2x/week; Preserved visual and auditory acuity; Physically able to operate the tablet and perform the paper-and-pencil training; Motivation to participate. Exclusion Criteria: Diagnosis of concomitant neurological and/or psychiatric disorders; Hemianopsia; Unilateral neglect; Aphasia syndromes.

Sites / Locations

  • ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 FunchalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group 1. Tablet-based CT (NeuroAIreh@b)

Experimental group 2. Paper-and-pencil CT (Task Generator).

passive control group (Waiting-list).

Arm Description

Participants in the NeuroAIreh@b group will perform tablet-based CT tasks personalized to their underlying deficits and performance in each iteration. Biweekly 30-minute sessions until reaching 12 sessions.

Participants in the paper and pencil group will perform CT tasks personalized to their cognitive deficits (according to the MoCA) and generated automatically through the Task Generator website (https://neurorehablab.arditi.pt/TaskGenerator/). Biweekly 30-minute sessions until reaching 12 sessions.

Participants in this group will not be enrolled in any intervention during the course of the study. At the end of the study, participants can integrate a CT intervention of their choice (e.g., CT through the NeuroAIreh@b platform or the TG).

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment (MoCA)
change from baseline to post-intervention, and baseline to follow-up, in the MoCA; Min score=0; Max score=30; Higher are indicative of a better performance;
Symbol Search and Digit Symbol (WAIS-III)
change from baseline to post-intervention, and baseline to follow-up, in both the Symbol Search and the Digit Symbol (WAIS-III); Min score=0; Max score=Dependent on participants' performance during the 120 seconds tasks. Higher scores in both subtests are indicative of a better performance.
Toulouse-Piéron Cancellation Test (TP)
change from baseline to post-intervention, and baseline to follow-up, in the TP; Min and Max scores=dependent on participants' performance during 10 minutes. A higher work efficiency index is indicative of a better performance, while a higher dispersion index is indicative of a worse performance.
Rey-Complex Figure Test (ROCFT)
Change from baseline to post-intervention, and baseline to follow-up, in the ROCFT; Min score=0; Max score=36. Higher scores on both the copy trial and 3-minutes immediate recall trial are indicative of a better performance.
Auditory Verbal Learning Test (AVLT)
Change from baseline to post-intervention, and baseline to follow-up, in the AVLT; Min score=0; Max score=varies across trials (5 immediate recall trials: 75 points; 1 delayed recall trial: 15 points; 1 delayed recognition task: 30 points). Higher scores are indicative of a better performance.
Verbal Fluency Tests
Change from baseline to post-intervention, and baseline to follow-up, in the verbal fluency tests; Min score=0; Max score=dependent on participants' performance during the 1-minute task. Higher scores on the verbal fluency tests are indicative of a better performance.

Secondary Outcome Measures

Subjective Memory Complaints Questionnaire (SMCQ)
Change from baseline to post-intervention, and baseline to follow-up, in the SMCQ; Min score=0; Max score=21; Higher scores are indicative of worse self-perceived memory decline.
Hospital Anxiety and Depression Scale (HADS)
Change from baseline to post-intervention, and baseline to follow-up, in the HADS; Min score=0; Max score=42; Higher scores are indicative of worse self-perceived emotional stability.
Quality of Life after Brain Injury (QOLIBRI)
Change from baseline to post-intervention, and baseline to follow-up, in the QOLIBRI; Min score=0; Max score=100; Higher scores are indicative of greater self-perceived quality of life.
Adults and Older Adults Functional Assessment Inventory (IAFAI)
Change from baseline to post-intervention, and baseline to follow-up, in the IAFAI; Min=0; Max=100; Higher scores are indicative of a worse self-reported functional disability.
Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q)
Change from baseline to post-intervention, and baseline to follow-up, in the MOT-Q; Min=-62; Max=62; Higher scores indicate higher motivation for rehabilitation.

Full Information

First Posted
June 5, 2023
Last Updated
June 23, 2023
Sponsor
Universidade da Madeira
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1. Study Identification

Unique Protocol Identification Number
NCT05929287
Brief Title
Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke
Official Title
A Comparison Between Personalized and Adaptive Tablet-based Cognitive Training and Paper-and-pencil Cognitive Training: a Randomized Controlled Trial With Community Dwelling Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to assess the efficacy of two cognitive training programs - one tablet-based (NeuroAIreh@b) and one in paper-and-pencil format (Task Generator) - in improving cognitive and noncognitive outcomes among community-dwelling stroke survivors. This study will include a waiting-list control group to assess the impact of these interventions and provide further insights into their potential for stroke survivors.
Detailed Description
The investigators plan to conduct a multicentric clinical trial with 45 participants randomly assigned to one of three groups. The study will have three arms, with each group receiving one of the following interventions: table-based cognitive training (NeuroAIreh@b), paper-and-pencil cognitive training (Task Generator) or no intervention (waiting-list control group). The latter group will not receive intervention during the study but will be offered the opportunity to participate in one of the cognitive training programs after completing the study. Additionally, the investigators will assess participants at three different time points: before the intervention (pre-intervention), immediately after the intervention (post-intervention), and three months after the intervention (follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants won't be aware of which group they are randomized to.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1. Tablet-based CT (NeuroAIreh@b)
Arm Type
Experimental
Arm Description
Participants in the NeuroAIreh@b group will perform tablet-based CT tasks personalized to their underlying deficits and performance in each iteration. Biweekly 30-minute sessions until reaching 12 sessions.
Arm Title
Experimental group 2. Paper-and-pencil CT (Task Generator).
Arm Type
Experimental
Arm Description
Participants in the paper and pencil group will perform CT tasks personalized to their cognitive deficits (according to the MoCA) and generated automatically through the Task Generator website (https://neurorehablab.arditi.pt/TaskGenerator/). Biweekly 30-minute sessions until reaching 12 sessions.
Arm Title
passive control group (Waiting-list).
Arm Type
No Intervention
Arm Description
Participants in this group will not be enrolled in any intervention during the course of the study. At the end of the study, participants can integrate a CT intervention of their choice (e.g., CT through the NeuroAIreh@b platform or the TG).
Intervention Type
Procedure
Intervention Name(s)
Tablet-based CT
Intervention Description
This group will perform digital CT tasks.
Intervention Type
Procedure
Intervention Name(s)
Paper-and-pencil CT group
Intervention Description
This group will perform paper-and-pencil CT tasks.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
change from baseline to post-intervention, and baseline to follow-up, in the MoCA; Min score=0; Max score=30; Higher are indicative of a better performance;
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Title
Symbol Search and Digit Symbol (WAIS-III)
Description
change from baseline to post-intervention, and baseline to follow-up, in both the Symbol Search and the Digit Symbol (WAIS-III); Min score=0; Max score=Dependent on participants' performance during the 120 seconds tasks. Higher scores in both subtests are indicative of a better performance.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Title
Toulouse-Piéron Cancellation Test (TP)
Description
change from baseline to post-intervention, and baseline to follow-up, in the TP; Min and Max scores=dependent on participants' performance during 10 minutes. A higher work efficiency index is indicative of a better performance, while a higher dispersion index is indicative of a worse performance.
Time Frame
: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Title
Rey-Complex Figure Test (ROCFT)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the ROCFT; Min score=0; Max score=36. Higher scores on both the copy trial and 3-minutes immediate recall trial are indicative of a better performance.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Title
Auditory Verbal Learning Test (AVLT)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the AVLT; Min score=0; Max score=varies across trials (5 immediate recall trials: 75 points; 1 delayed recall trial: 15 points; 1 delayed recognition task: 30 points). Higher scores are indicative of a better performance.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Title
Verbal Fluency Tests
Description
Change from baseline to post-intervention, and baseline to follow-up, in the verbal fluency tests; Min score=0; Max score=dependent on participants' performance during the 1-minute task. Higher scores on the verbal fluency tests are indicative of a better performance.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Secondary Outcome Measure Information:
Title
Subjective Memory Complaints Questionnaire (SMCQ)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the SMCQ; Min score=0; Max score=21; Higher scores are indicative of worse self-perceived memory decline.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the HADS; Min score=0; Max score=42; Higher scores are indicative of worse self-perceived emotional stability.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Title
Quality of Life after Brain Injury (QOLIBRI)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the QOLIBRI; Min score=0; Max score=100; Higher scores are indicative of greater self-perceived quality of life.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Title
Adults and Older Adults Functional Assessment Inventory (IAFAI)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the IAFAI; Min=0; Max=100; Higher scores are indicative of a worse self-reported functional disability.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Title
Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q)
Description
Change from baseline to post-intervention, and baseline to follow-up, in the MOT-Q; Min=-62; Max=62; Higher scores indicate higher motivation for rehabilitation.
Time Frame
baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke diagnosis; Maximum age: 75 years old; Education: at least three years of formal education; Relatively preserved language abilities (expressive and receptive language); Residing in the community; Availability to go to the hospital 2x/week; Preserved visual and auditory acuity; Physically able to operate the tablet and perform the paper-and-pencil training; Motivation to participate. Exclusion Criteria: Diagnosis of concomitant neurological and/or psychiatric disorders; Hemianopsia; Unilateral neglect; Aphasia syndromes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joana Daniela F Câmara
Phone
965441077
Email
joana.fcamara@gmail.com
Facility Information:
Facility Name
ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal
City
Funchal
ZIP/Postal Code
9020-105
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joana Daniela F Câmara, MSc
Phone
965441077
Email
joana.fcamara@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

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