High-tech therapy, an innovative field of neurorehabilitation, has expanded rapidly in recent years. Advances in technology have enabled the use of devices that can assist with movement development from simple movements to more complex tasks.
This research investigates the effectiveness of rehabilitation programmes that complement robot-assisted therapy to help people relearn to walk in post-stroke rehabilitation. This would be measured in two variations, with the patient (in addition to a complex rehabilitation programme of conventional physiotherapy, occupational therapy, hydrotherapy, etc.) receiving either treadmill or no treadmill treatment. In both cases, the therapies will be carried out with advanced technology-based equipment (both treatments are part of the daily routine of the Institute's treatments, and the equipment will be used according to the instructions in the user manual), the C-Mill interactive robot-assisted device will be used for treadmill therapy, and the Andago robot-assisted device for non- treadmill therapy. There is no sharp distinction between the two systems. The inclusion and exclusion criteria are set so patients' conditions meet the indications for both devices, and patients eligible for treatment with one device are included in the other.
In our study, 80 patients will be selected.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hemiparetic patient who has had a stroke;
* ischaemic or haemorrhagic stroke confirmed by CT or MRI;
* female or male between 40 and 75 years of age;
* subgroup 1: less than 3 months since stroke,
* subgroup 2: more than 3 months but less than 1 year since stroke;
* physical fitness adequate for the exertion of the treatment;
* right or left lower limb involvement;
* score 3 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate on a level surface without manual contact of another person but requires standby guarding of one person either for safety or verbal cueing;
* or score 4 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate independently on a level surface but requires supervision to negotiate (e.g. stairs, inclines, non-flat surfaces);
* be able to participate in therapy and cooperate based on cognitive function;
* signed informed consent.
Exclusion Criteria:
* More than 1 year has passed since the stroke;
* scores less than or equal to 3 on the Functional Ambulation Categories (FAC) scale;
* patients who were unable to walk independently before the stroke;
* patients treated with botulinum toxin in the lower limb in the last 3 months;
* use of other lower limb advanced technology treatments during the study;
* a person with limited capacity;
* not physically able to bear weight;
* severe aphasia (impairment of understanding or expression that severely impedes co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Balancing skills
Timeframe: Through study completion, an average of 2 years.
2
Balancing skills
Timeframe: Through study completion, an average of 2 years.
3
Balancing skills
Timeframe: Through study completion, an average of 2 years.
4
Balancing skills
Timeframe: Through study completion, an average of 2 years.
5
Balancing skills
Timeframe: Through study completion, an average of 2 years.
6
Balancing skills
Timeframe: Through study completion, an average of 2 years.
7
Balancing skills
Timeframe: Through study completion, an average of 2 years.
8
Trial details
NCT IDNCT06497309
SponsorNational Institute for Medical Rehabilitation, Hungary