ongitudinal observational study of sensorimotor hand impairments after stroke using robot-assisted assessments
- Conditions
- I64Stroke, not specified as haemorrhage or infarction
- Registration Number
- DRKS00022952
- Lead Sponsor
- Kliniken Schmieder Allensbach
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
1. Diagnosis of stroke (ischemic or hemorrhagic)
2. Subacute stroke at study inclusion (< 3 months since stroke at first measurement)
3. Sufficient cognitive function to understand task instructions (as assessed by the recruiting physiotherapist)
4. No pain when inserting the index finger in the robotic device
5. Minimum passive range of motion of the index finger (30 degrees)
6. No strong spasticity (Modified Ashworth Scale <= 3)
7. At least 40% of recruited subjects (20/50) should have some proprioceptive deficits according to the clinical scale (kinaesthetic Up-Down test from NSA < 3)
8. At most 40% of recruited subjects (20/50) should stay in the clinic < 5 weeks (inclusion and discharge measurement only)
For TMS only:
1. Heart pacemaker
2. Metallic implants in the brain
3. Pregnancy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Robotic metrics. <br>What and how: e.g. index finger velocity, position, force - metrics extracted from the robotic device ETH MIKE (as described here: https://ieeexplore.ieee.org/document/8779507) <br>When: at every measurement point (every 2 weeks while patients are undergoing usual rehabilitation)
- Secondary Outcome Measures
Name Time Method Clinical outcomes: Box & Block test, Nottingham Sensory Assessment, Montreal Cognitive Assessment, Fugl-Meyer Assessment, Barthel Index, Neglect Assessment (Bell Test); Neurophysiology: MEP and SSEP amplitude & latency; Neuroimaging: lesion location<br>These are only collected at inclusion and after 4 weeks of rehabilitation.