I69.4
Conditions
Interventions
Group 1: The study is conducted as a randomized cross-over trial with post-stroke patients 3-6mth after stroke, ensuring that all participants complete both a phase of increased physical activity and
Sponsors
Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: Minor ischemic stroke within the past 80–190 days NIHSS < 6 at the time of examination mRS < 3 (mild to moderate impairment)
Exclusion criteria
Exclusion criteria: history of neurological disorders memory problems psychotropic medication signs of dementia (MoCA < 23 points) alcohol abuse, other substance dependencies inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the intervention-related difference in sequence-specific learning performance on the Serial Reaction Time Task (SRTT). Sequence-specific performance is assessed based on block reaction times in structured versus randomized sequences (structured vs. random). The primary effect is tested as a Group × Time Point (Baseline vs. 1 week) × Condition (structured vs. random) interaction at the block level. The analysis is conducted using a mixed-effects model with log-transformed reaction times and adjustment for the a priori specified covariates age, log(time since stroke), MID, BDI-II, and MoCA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reward sensitivity (MID): Intervention-related difference in reaction time modulation in the Monetary Incentive Delay Task (MID) between phases and measurement time points. The Phase × Measurement Timepoint interaction will be tested on the a priori defined contrasts (high vs. no reward; optional: medium vs. no reward) in a mixed model with the same covariates as the primary endpoint. MID as a moderator of the SRTT effect: Testing whether individual reward sensitivity (MID contrast) moderates the intervention effect on sequence-specific learning (MID-measure × phase × measurement time interaction in the SRTT model). Autonomic regulation (HRV): Intervention-induced difference in heart rate variability, tested as a phase × measurement time interaction. The MID baseline contrast, BDI-II, and SRT are also included as covariates here. Functional connectivity (fMRI/sMRI): Changes in the functional connectivity of motor and reward-associated networks across phases and measurement time points. Motivational and affective symptoms: Changes in standardized self-report measures (apathy: AES; depressive symptoms: BDI-II; SHAPS) across phases and measurement time points. | — |
Countries
Germany
Contacts
Public ContactFranziska Wagner
Klinik für Neurologie
Outcome results
None listed