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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04632719
Other study ID # MentalPlus®
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2020
Est. completion date December 29, 2023

Study information

Verified date March 2024
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.


Description:

Subjects who contracted COVID-19 and present remission of symptoms will be studied, with different age groups, illiterate or literate, of both genders and with different socio-demographic characteristics. The volunteers will be submitted to the application of MentalPlus® to assess cognitive functions and SF-8® to assess Quality of Life.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 29, 2023
Est. primary completion date December 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 88 Years
Eligibility Inclusion Criteria: - Patients affected by COVID-19 with or without comorbidity for cardiovascular diseases, diabetes mellitus, hypertension, cancer, asthma between the ages of 8 and 88 years of both sexes and illiterate or literate. Exclusion Criteria: - Disability for the instrument's use: limitation for the mobility of the upper limbs, presence of significant mental retardation that compromises the understanding of the instructions for the use of MentalPlus®, significant lowering of visual acuity.

Study Design


Intervention

Device:
The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.

Locations

Country Name City State
Brazil Livia Stocco Sanches Valentin Sao Paulo
Brazil Livia Stocco Sanches Valentin São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (40)

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27. Valentin LSS, Valentin TSS, Carmona MJC, Garcia RC, Correa RD, Gondim GB, et al. Mental Plus. INPI - Instituto Nacional da Propriedade Intelectual. 2014.

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Pereira VFA, Valentin LSS. The MentalPlus(R) Digital Game Might Be an Accessible Open Source Tool to Evaluate Cognitive Dysfunction in Heart Failure with Preserved Ejection Fraction in Hypertensive Patients: A Pilot Exploratory Study. Int J Hypertens. 2018 Aug 6;2018:6028534. doi: 10.1155/2018/6028534. eCollection 2018. — View Citation

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* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of cognitive functions after COVID-19 The evaluation of cognitive functions by the digital game MentalPlus® (a scale of assessment and cognitive rehabilitation) will take place as follows: Scores range from 0 [Not improved] to 10 [fully improved] at cognitive functions memory, attention and executive after training with Scale. This game is already validated and standardized for the global population. The test takes 25 minutes to play, is playful and self-explanatory. It has twelve themes with cognitive functions: short and long-term memory; selective, alternate and concentrated attention, inhibitory control of executive function and visual perception. MentalPlus® is completely randomized in its phases and themes. Therefore, the game can be used for cognitive assessment with a single theme (25 minutes of execution) or rehabilitation on 10 more themes and a final theme for reassessment of cognitive functions. 1 year
Secondary Rehabilitation of cognitive functions after COVID-19 Rehabilitation of cognitive functions: executive, attention, memory, visual perception, language, after the remission of the symptoms of COVID-19. MentalPlus® will be used in order to rehabilitate the cognitive functions of patients who have dysfunctions after COVID-19. The patient will play on alternate days (every other day) a theme of the game and will be rehabilitated through its 10 themes. At the end of these 10 themes, the patient will be reassessed by the last theme of the game, comprising a total of 12 themes. Each theme lasts for 25 minutes each. 1 year
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