Rehab after stroke post-stroke-patients
Conditions
Interventions
Group 1: This is a single-center, prospective, randomized, controlled intervention study being conducted at the Stroke Unit of Jena University Hospital.
After receiving informed consent, eligible pat
Sponsors
Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients aged 55 to 85 years with a first acute ischemic infarction in the middle cerebral artery territory in the early post-stroke phase. Eligible patients must be able to provide informed consent and be treated in the stroke unit or early neurorehabilitation setting. Patients should have mild to moderate motor impairment of the upper extremity, defined as arm paresis with a muscle strength grade of 4–5, an NIHSS upper-extremity motor score of no more than 2 points, a total NIHSS score = 6, and an mRS = 3. Study participation takes place between day 1 and day 10 after stroke. Patients should have comparable motor impairment and receive comparable physiotherapy and occupational therapy.
Exclusion criteria
Exclusion criteria: Patients are excluded in case of current or previous depression, current depressive symptoms with a BDI score > 10, dementia or cognitive impairment with a MoCA score = 22, aphasia or apraxia, relevant visual impairment > 3 diopters, or pronounced motion sickness. Patients unable to provide informed consent or patients under legal guardianship are not eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What / Outcome: The primary outcome is sequence-specific performance in the Serial Reaction Time Task (SRTT) at the block level. It is operationalized as the reaction time difference between structured and randomized blocks. Reaction times from correct trials will be analyzed, recorded in milliseconds and log-transformed if appropriate. Estimand / Hypothesis: The primary analysis will test whether the change in sequence-specific performance from day 1 to day 2 differs between the intervention and control groups. Formally, this corresponds to the group × day × condition interaction in the block-based model, with condition representing structured versus randomized blocks. This three-way interaction constitutes the primary endpoint test and assesses whether the development of sequence expression over time differs between groups. Time points: Day 1 and day 2, corresponding to two consecutive training days. Analysis: The analysis will be performed using a mixed-effects model at the block level, with log-transformed reaction time as the dependent variable. Fixed effects will include group, day, condition, block number, and the relevant interactions. The model will be adjusted a priori for age, motor impairment, for example S-FMA, and cognitive function, for example MoCA. A random intercept for each participant will be included. The primary test will be the significance of the group × day × condition interaction. In addition, pre-specified contrasts, for example estimated marginal means, will be used to quantify the sequence-specific benefit within each group and its change from day 1 to day 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Confirmation of the sequence-learning signature As a key secondary outcome, we will assess whether the expected sequence-learning signal can be detected in the SRTT. For this purpose, we will analyze whether structured blocks are performed faster than randomized blocks. 2. Speed–accuracy coupling In addition, the relationship between reaction time and error measures will be examined, for example using the block-wise error rate. We will assess whether the association between reaction time and errors differs between the intervention and control groups. 3. Motivation and reward-related experience Motivation and reward-related experience will be assessed using the MORE score on day 1 and day 2. The intervention and control groups will be compared with regard to overall levels and changes over time. 4. Subjective experience of the VR application In the intervention group, a VR-specific post-intervention questionnaire will additionally be administered on day 2 to assess subjective experience, acceptability, and tolerability of the VR application. This outcome will be analyzed descriptively. Time points: Baseline / day 1 and follow-up / day 2. The VR-specific post-intervention questionnaire will be administered exclusively on day 2 and only in the intervention group. | — |
Countries
Germany
Contacts
Public ContactFranziska Wagner
Universitätsklinikum Jena
Outcome results
None listed