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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Switzerland
Lausanne University Hospital (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Giulia Binarelli, PhD
giulia.binarelli@chuv.ch
+41 21 314 25 42
Backup
Arseny A. Sokolov, Prof MD PhD
arseny.sokolov@chuv.ch
+41 79 556 73 55
Time Frame
Start Date: 2022-03-17
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 32
Treatments
Active_comparator: Control group (CTR)
Computerized Gaming Rehabilitation Program 1
Experimental: Intervention group (INT)
Computerized Gaming Rehabilitation Program 2
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Vaudois

This content was sourced from clinicaltrials.gov