Stroke Clinical Trial
— SACSOOfficial title:
Simultaneous Recording of Cognitive and Motor Functions After Stroke : Dissociation of Motor and Cognitive Deficits
| NCT number | NCT05454748 |
| Other study ID # | D19-P043 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 3, 2022 |
| Est. completion date | June 20, 2023 |
| Verified date | June 2022 |
| Source | Centre Hospitalier St Anne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects. Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | June 20, 2023 |
| Est. primary completion date | June 20, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - > 18 years old - First symptomatic stroke more than 3 months ago - Box and blocks test score < 52 - Mini Mental State Examination Test > 25 Exclusion Criteria: - Psychiatric disease - Risk of Pregnancy - History of previous stroke - Disability that may interfere with the performance of tasks |
| Country | Name | City | State |
|---|---|---|---|
| France | GHU Sainte Anne | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier St Anne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Saccade inhibition rate | Cross sectional comparison of % of saccades performed towards visual distractors | Baseline measurement (one occasion) |
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