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Robot-Assisted Training Versus Standard Training in Ischemic Stroke

RecruitingNAAges 18 Years - anyAllOdense University Hospital
NCT06273475 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion: 1. Ischemic and haemorrhagic stroke 2. Chronic state (6-24 months post-stroke). 3. Subacute rehabilitation terminated (subacute phase defined as until 6 months post-stroke). 4. Moderately-severely impaired: 1. Modified Rankin Scale Score 3-5. 2. Scandinavian Stroke Scale Leg Motor Function Score 0-4 and/or SSS gait function 0-9. 5. Approved by referring doctor Exclusion: 1. Prior SAH 2. Infarct located in the cerebellum or brain stem 3. Severe fatigue making study completion improbable. 4. Cognitive deficits impeding study participation. 5. Inability to walk independently pre-stroke. 6. Recurrence of cardiovascular/cerebrovascular accidents. 7. Pre-existing neurological diseases or ongoing cancer treatment. 8. Refusing group allocation. 9. Concurrent participation in another clinical trial potentially interacting with the present trial.
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What it tests

  • Robot-assisted Training
  • Standard Training
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Where

2 sites
Rigshospitalet and Herlev Gentofte Hospital
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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