The goal of this interventional study is to assess differences in the metabolic consumption, the cardiorespiratory effort, the cardiac autonomic adaptation, and fatigability during ADL, such as standing from a chair and walking while wearing an electrically powered exoskeleton in different modes of supports in subjects with neurological diseases with moderate to severe walking impairments.
Who can participate
Age range
18 Years – 90 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:
* Able to perform 4 minutes of back-and-forth locomotion with assistance or resting periods;
* Height between 160 and 195 cm;
* Weight not exceeding 100 kg;
* Diagnosis of Multiple Sclerosis with moderate to severe disability (5,5 \< EDSS \< 8,0);
* Diagnosis of stroke or traumatic brain damage (1 ≤ FAC ≤ 3);
* Diagnosis of spinal cord injury with neurological level of injury\<T2 (3 ≤ WISCI II ≤ 16) with a Asia Impairment Score B, C or D.
* Able to perform 4 minutes of back-and-forth locomotion with assistance or resting periods;
* Able to use walker;
Exclusion Criteria:
* Impairments in the upper limbs that do not allow the user to hold the crutches/walker.
* Skin injuries in the areas where the exoskeleton is in contact with the user.
* Fractures not solved or bone pathologies in lower limbs in which the use of the exoskeleton could be risky (advanced osteoporosis).
* Psychiatric or cognitive problems that can interfere with the correct use of the device.
* Important muscle/joint retractions in lower limbs (Modified Ashworth Scale \> 3).
* Any medical conditions that could interfere with the autonomic cardiovascular control (e.g severe diabetes).
* Use of beta blocker drugs.
* Presence of severe cardiovascular diseases.
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
Walking meters change during 4 minute walking test
Timeframe: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)