A stroke is a vascular condition that can suddenly cause the loss of neurological functions. The disability derived from a stroke can imply reduced communication and limited activities of daily living in the long term.
Thus, specifically walking rehabilitation is crucial in order to restore the lower limbs' function and to re-establish the social participation of patients.
Robotics has been demonstrated in being a suitable and effective tool in order to assist and treat post-stroke patients, thanks to its capability to deliver intensive and task-oriented training. Specifically, the exosuits, are a sub-group of robotics devices designed in lighter materials that assist the patients by actively moving the hip, knee or ankle.
Given this framework, the aim of this work is to conduct a pilot study on the usability and perceived effectiveness of a lower-limb exosuit, the Myosuit device, on post-stroke patients. The secondary aims of the study concern the evaluation of the functional performances of the patients both with and without the device and before and after the treatment.
Who can participate
Age range
18 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:
* Clinical stability, evaluated through the administration of the MEWS scale (Modified Early Warning Score);
* To be able to stand up from a chair without exceeding a trunk angle of 45° to the left or right during the movement;
* To be able to walk for 10 m without the support of another person but, if necessary, with conventional aids different than knee othesis (e.g. stick, crutch, ankle/foot orthesis). The aid considered should have single-support;
* Height between 150 cm and 195 cm;
* Weight between 45 kg and 110 kg;
* FAC (Functional Ambulation Calssification) ≥3;
* MAS (Modified Ashworth Scale) ≤2;
* HADS (Hospital Anxiety and Depression Scale) with normative values (\>10/21 for each scale);
* MoCA (Montreal Cognitive Assessment) (Equivalent scoring \> 1 with the Italian correction from Santangelo et al.\_ 2015);
* To be able to understand and sign the informed consent.
Exclusion Criteria:
* Presence of an active (or with effects) neurological or psychiatric pathology occurred before the vascular event;
* Severe bilateral hearing or sight loss;
* Functional Reach Test \<15.24;
* Flexion retruction of hip and knee greater than 10° and not reducible;
* Presence of genu varum or geru valgum greater than 10°;
* Pregnancy;
* Previous stroke.
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
Usability of the device
Timeframe: Evaluated at session 10 (after the treatment) at an average of 3 weeks
2
Self-efficacy
Timeframe: Evaluated at session 10 (after the treatment), at an average of 3 weeks