NCT04559724Active, not recruiting
Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes
Longitudinal Pilot Study on the Feasibility of Integrating Gait Training Through a Novel Over-ground Wearable Robotic System to Traditional Rehabilitation in People With Pyramidal Hemisyndromes.
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 7 Sept 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- IRCCS San Raffaele Roma
- Diseases
- Stroke
- NCT number
- NCT04559724
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Sept 2020 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cognitive impairment or behavioral dysfunction such as not to understand or participate in the whole execution
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Pisana Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.