Computerized cognitive rehabilitation for stroke patients with executive deficits
Combined Cognitive and Physical Training for the Neurorehabilitation of Executive Deficits After Stroke: an Exploratory Randomized Controlled Trial
This study tests whether a six-week program of computer exercises that mix brain and physical training can help stroke patients improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT05169632 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two sets of computerized exercises that combine cognitive and physical training to improve executive function in stroke patients. Participants will undergo initial cognitive and physical assessments, followed by a six-week training program consisting of three sessions per week. After the training, their cognitive and physical abilities will be re-evaluated, and a follow-up assessment will occur six months later to determine the long-term effects of the training. The study aims to provide insights into the potential benefits of gamified rehabilitation for cognitive deficits post-stroke.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke at least eight weeks prior and exhibit cognitive deficits related to executive function.
Not a fit: Patients with major neurocognitive disorders or significant physical impairments that prevent participation in the training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance cognitive recovery and improve the quality of life for stroke patients suffering from executive dysfunction.
How similar studies have performed: While the specific combination of cognitive and physical training in this format is novel, similar approaches in cognitive rehabilitation have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Ischemic or haemorrhagic cerebral stroke ≥ 8 weeks before study inclusion * Cognitive complaint and/or clinical impression of dysexecutive syndrome * Z-Score \< -1.0 in at least two of the following domains * Cognitive flexibility (Trail-Making Test B/A) * Cognitive interference (Stroop color word interference task) * Divided attention (TAP divided attention) * Working memory (TAP working memory, Forward Digit Span, Backward Digit Span) * Design fluency (Five-points test) Exclusion Criteria: * Major neurocognitive disorder according to the DSM-5 * Proximal extremity paresis grade \< M4 on the Medical Research Council (MRC) Scale for Muscle Strength in at least one of four extremities * Insufficient visual acuity, visual field or hemispatial attention to engage in the training * Inability to discriminate colour: \< 12 points on the Ishihara test * Changes over the last 4 weeks in antidepressive, anxiolytic or in acetylcholinesterase inhibitor drugs * Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report) * Clinically unstable cardio-vascular disease * Falls in the past 12 weeks as evaluated in the enrolment interview \[Hopkins Falls Grading Scale (Grade \>1)\] * High risk of falling according to a score of over 15 seconds on the Four Square Step Test (FSST) * Insufficient knowledge or capacity of French to follow instructions * Incapacity or unwillingness to provide informed consent
Where this trial is running
Lausanne, Canton of Vaud
- Lausanne University Hospital (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Arseny A. Sokolov, Prof MD PhD — Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
- Study coordinator: Giulia Binarelli, PhD
- Email: giulia.binarelli@chuv.ch
- Phone: +41 21 314 25 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.