Robot-Assisted Training Versus Standard Training in Ischemic Stroke
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 subacu
| Condition(s) | Stroke, Ischemic Stroke |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 cli |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Odense University Hospital |
| Locations | Copenhagen, Denmark; Odense, Denmark |
| Start date | 2024-05-01 |
| NCT ID | NCT06273475 |
| Official listing | https://clinicaltrials.gov/study/NCT06273475 |