Comparing robot-assisted training to standard training for stroke recovery
The Effect of Robot-Assisted Versus Standard Training on Motor Function Following Subacute Rehabilitation After Ischemic Stroke - a Randomised Controlled Trial Nested in a Prospective Cohort.
This study is testing if robot-assisted training can help people with moderate to severe stroke recover better than regular training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT06273475 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of robot-assisted training compared to standard training in improving motor function, physical function, fatigue, and quality of life in individuals with moderate to severe impairments following ischemic stroke. Participants will be recruited from multiple hospitals and will undergo training designed to alleviate the burden of body weight during rehabilitation. The study focuses on chronic stroke patients who have completed subacute rehabilitation and assesses various functional outcomes to determine the superiority of the robot-assisted approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 or older who are 6 to 24 months post-ischemic stroke and have moderate to severe impairments.
Not a fit: Patients with severe cognitive deficits, prior significant neurological conditions, or those unable to walk independently prior to their stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation outcomes and quality of life for stroke survivors.
How similar studies have performed: Previous studies have shown promising results for robot-assisted rehabilitation in stroke recovery, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen and 1 other locations
- Rigshospitalet and Herlev Gentofte Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Jon Skovgaard Jensen, Ph.d.-student — Department of Clinical Research, University of Southern Denmark
- Study coordinator: Jon Skovgaard Jensen, Ph.d.-student
- Email: jskovgaard@health.sdu.dk
- Phone: +4530127595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.