Gait Training Through a Novel Over-ground Wearable Robotic System in People with Pyramidal Hemisy… (NCT04559724) | Clinical Trial Compass
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Gait Training Through a Novel Over-ground Wearable Robotic System in People with Pyramidal Hemisyndromes
Italy30 participantsStarted 2020-09-01
Plain-language summary
Over-ground exoskeletons for gait rehabilitation are studied enough in people suffering spinal cord injury, and its clinical use is escalating in the industrialized countries. Nevertheless, studies on gait rehabilitation through exoskeletons in subjects with Pyramidal Hemisyndrome (PH) are recognized by GRADE as Low Quality of evidence.
This interventional longitudinal pilot study is aimed to investigate the feasibility, clinical effects, and compliance (from the experienced therapists (Indego Specialists)' point of view) of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH in the clinical practice.
Two substudies will be conducted with the following aims: to explore changes in the gait pattern and muscle activity following Indego-assisted gait rehabilitation through the kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs; to identify prognostic factors for walking recovery, investigating also the effect of the treatment on functional connectivity through the electroencephalographic (EEG) analysis.
In order to satisfy the study aims, 30 subjects with PH and walking impairment will be recruited and assessed both clinically and instrumentally (in case of substudies) at the beginning (T0) and the end (T1) of the treatment period.
Who can participate
Age range
18 Years – 80 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:
* Single or multiple unilateral Cerebral Stroke
* Mild / moderate Traumatic Brain Injury
* Brain Tumor Benign
* Possibility to keep the upright position for at least 1 minute with good cardiovascular compensation and:
* With double support and supervision;
* With double support without supervision;
* With single support and supervision;
* With single support without supervision;
* With assistance not exceeding 50%;
* With supervision only.
Exclusion Criteria:
* Severe cognitive impairment or behavioral dysfunction such as not to understand or participate in the whole execution
* Refusal or impossibility to provide informed consent
* Impossibility to wear the robot:
* for serious functional limitations in the coxo-femoral joints and knees;
* marked hyper tone with sudden spasms in flexion;
* Modified Ashworth Scale \> 3;
* weight over 113 Kg;
* height less than 155 cm or higher than 195 cm;
* hip width greater than 46 cm.
* Sever cardio-respiratory co-morbidities.
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
Changes in 6 Minute Walk Test (6MWT)
Timeframe: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).