Actively Recruiting
Robot-Assisted Training Versus Standard Training in Ischemic Stroke
Led by Odense University Hospital · Updated on 2025-11-20
40
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
U
University of Southern Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation. The main hypothesis of the study is: Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training.
CONDITIONS
Official Title
Robot-Assisted Training Versus Standard Training in Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ischemic or hemorrhagic stroke
- Between 6 and 24 months post-stroke (chronic phase)
- Completed subacute rehabilitation phase (up to 6 months post-stroke)
- Moderate to severe impairment with Modified Rankin Scale score 3-5
- Scandinavian Stroke Scale leg motor function score 0-4 and/or gait function score 0-9
- Approved by referring doctor
You will not qualify if you...
- Prior subarachnoid hemorrhage (SAH)
- Stroke infarct located in the cerebellum or brain stem
- Severe fatigue making study completion unlikely
- Cognitive deficits that prevent participation
- Inability to walk independently before stroke
- Recurrence of cardiovascular or cerebrovascular events
- Pre-existing neurological diseases or ongoing cancer treatment
- Refusal of group allocation
- Participation in another clinical trial that could interfere with this study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rigshospitalet and Herlev Gentofte Hospital
Copenhagen, Denmark
Not Yet Recruiting
2
Odense University Hospital
Odense, Denmark
Actively Recruiting
Research Team
J
Jon Skovgaard Jensen, Ph.d.-student
CONTACT
A
Anders Holsgaard-Larsen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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