Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients

Stroke Clinical Trial

Official title: Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

WHO: 32 participants with executive deficits related to a stroke, able to engage in moderate physical activity.

WHY: Around one third of stroke patients suffer from cognitive deficits in the long term, which have a detrimental impact on everyday personal and professional life. The purpose of this study is to evaluate two sets of computerized exercises combining cognitive and physical effort to see if they can improve executive function.

WHAT: Study participants first undergo cognitive and physical assessments. Additional questionnaires will assess mood, everyday life cognition, function and quality. This will be followed by a 6 week training period with 3 training sessions a week. The effect of the cognitive and physical training will be measured in a post-training evaluation session. Six months after completion of the training, the study will evaluate cognitive and physical abilities of participants to study long-term effects of the respective training program.

WHERE: Both the evaluation and the training sessions will be conducted on the premises of the Centre Hospitalier Universitaire Vaudoise (Pavillon 4, Avenue de Beaumont, 1005 Lausanne, Switzerland)

Clinical Trial Description

This is an exploratory Randomized Controlled Trial with the purpose of evaluating the potential of two sets of gamified cognitive and physical exercises in the neurorehabilitation of cognitive deficits following a stroke.

Upon recruitment, eligible study participants (see 'Eligibility Criteria') receive a detailed oral and written description about the scientific background, aims and methods of the study. Additional information will be provided about potential benefits and risks associated with study participation, as well as about the voluntary nature of participation throughout the study. The participant's written informed consent is required for study enrollment.

After inclusion in the study, participants are randomized into one of two different training programs with equal chance of attribution and without possibility of choosing:

• Program 1 involves brain training games with a physical exercise component.

• Program 2 involves cognitive training games with a physical exercise component.

Independently of program attribution, participants engage in a pre-training assessment, a six-week training period, a post-training assessment and a 6-month-follow-up assessment.

Before the start of the training, participants are required to perform several cognitive and physical tests and fill out a number of questionnaires on subjective cognitive function, mood and quality of life. The exercises and the questionnaires serve as a baseline evaluation of cognitive and physical function.

Following the first assessment, study participants engage in a 6-week training period. In both programs, participants engage in 3 weekly trainings of 90 minutes duration each.

After completion of the training period, study participants engage in a post-training assessment to evaluate the effect of training on cognitive and physical performance. This session incorporates the same tasks and questionnaires as in the pre-training visit. The aim of the post-training assessment is to demonstrate immediate training effect of the two programs.

A final follow-up visit is scheduled 6 months after the completion of the last training session. The cognitive and physical testing together with the questionnaires will be repeated to examine the long-term effects of the training programs. ;

Related Conditions & MeSH terms

• Executive Dysfunction
• Stroke

• NCT number: NCT05169632
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Aurélie Manuel Stocker, PhD
• Phone: +41 21 314 25 42
• Email: aurelie.manuel-stocker@chuv.ch
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Completion date: January 31, 2025