Pilot study of the robot-assisted therapy of hand proprioception after stroke
Phase 1
Recruiting
- Conditions
- I64Stroke, not specified as haemorrhage or infarction
- Registration Number
- DRKS00027932
- Lead Sponsor
- Kliniken Schmieder Allensbach
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
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)
Exclusion Criteria
None
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Robotic metrics.<br>What and how: index finger proprioception, range of motion, force, tracing smoothness - metrics extracted from the robotic device ETH MIKE (as described here: https://jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00904-5)<br>When: at inclusion and after 3 weeks of intervention (at discharge) <br>
- Secondary Outcome Measures
Name Time Method Clinical outcomes: Box & Block test, Nottingham Sensory Assessment (proprioception of index finger only), Montreal Cognitive Assessment, Neglect Assessment (Bell Test); Test of Attentional Performance (TAP). Collected at inclusion and at discharge (after 3 weeks of intervention). <br>Usability outcomes: NASA TLX, Likert scale (questionnaires). <br>Study drop-out rate, report of adverse events. <br>