NCT04559724

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: IRCCS San Raffaele Roma · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this interventional longitudinal pilot study is to investigate the feasibility of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH associated with the traditional rehabilitation. Secondary objectives of the study are: * To explore the clinical effects of the treatment; * To evaluate the feasibility of implementing this system in clinical practice from experienced therapists (Indego Specialists)' point of view. Two Sub-Studies (SS) will be conducted with the following aims: 1. Kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs in order to evaluate changes in the gait pattern and muscle activity following gait rehabilitation through an over-ground wearable exoskeleton system; 2. Electroencephalographic (EEG) analysis in order to: identify prognostic factors for walking recovery; investigate the effect of the treatment on functional connectivity. 30 subjects with PH and walking impairment who meet the research project inclusion and exclusion criteria will be recruited for this study. Patients will be evaluated at T0 and at T1. Demographic (gender, date of birth, height, weight, education, dominant side, work activity, presence of the social network, presence of architectural barriers at home) and clinical data (comorbidity, drug therapy, blood pressure, the cardiac frequency at rest, date of last acute event, number of previous neurological events, location of acute events) of all participants will be recorded at T0. In the case of Sub-Studies, 10 patients (able to walk fo 4 meters without aids but with supervision) for SS1 and 5 patients for SS2 following the first-ever monofocal cerebrovascular acute event will be recruited. These subjects will be assessed both clinically and instrumentally (SS1: through the gait analysis and sEMG; SS2: through the EEG) at T0 and T1.

Conditions

• Stroke
• Brain Injuries, Traumatic
• Brain Tumor Benign

Interventions

Type	Name	Description
DEVICE	Indego Therapy	Indego Therapy consists of 15 + 2 sessions of Indego - Therapy, each lasting 30 minutes for a maximum of 6 weeks. All the device parameters such as step height (knee and hip), step length, step cycle speed, single and bilateral assistance are customizable. The use of aids during Idego-Therapy is allowed if needed. The Indego specialist should initially be positioned behind the patient, checking the exoskeleton and patient's gait pattern. The supervision of an assistant placed on the patient's healthy side is recommended in the first sessions in order to ensure greater safety to the patient. Constant supervision should be provided by Indego specialist during the whole treatment.

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-05-21
• Completion: 2025-12-30
• First posted: 2020-09-23
• Last updated: 2024-10-04

Locations

1 site across 1 country: Italy