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Under way, not recruiting

Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes

NCT04559724 · IRCCS San Raffaele Roma · Updated 19 Oct 2026

What is being tested
Indego Therapy
For
Stroke; Brain Injuries, Traumatic; Brain Tumor Benign
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 30 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 1 Sept 2020, ends Dec 2026. Registered 23 Sept 2020.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT04559724

Sites

  • IRCCS San Raffaele PisanaRoma, Roma, Italy