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Clinical Trial Summary

Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted practice has shown positive outcomes. However, literature lacks of clinical studies on exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™, EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk, involving them directly in steps trigger through body weight balance. The main aim of this study is to assess the clinical and neuromuscular effects of exoskeleton-based gait rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar characteristics who will conduct a traditional over-ground gait training.

In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12 one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the training period. The primary outcome is the distance performed during the 6mwt. A follow up study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.

Clinical Trial Description

*Procedures During Screening Process:

This multicentric study will involve recruitment of individuals who have experienced a middle to severe stroke as well as patients with similar neurological weakness from the inpatient setting, outpatient clinics, as well as day rehabilitation sites through all the health institutes participating to this study project. Members of the research teams will perform the initial screening of potential subjects. These clinicians will determine study eligibility based on the inclusion and exclusion criteria provided by Ekso Bionics in accordance with the medical recommendations of Prof. Marco Franceschini.

Potential subjects will be asked questions regarding their medical history and current level of function. If the subject meets the criteria, researchers will then provide the subject with a consent form. The researchers will discuss the objectives, the study protocol, and the risks and benefits to each subject. The subjects will be given time to review the form and ask any questions about it.

Once each subject has provided informed consent, he or she will undergo a screening process to assess the joint range of motion, and any spasticity present (via Modified Ashworth Scale). These measures will be used to determine subject qualification based on inclusion and exclusion criteria. Vital signs (including heart rate, blood pressure and oxygen saturation) will be assessed at baseline, after each session, and during sessions as needed based on subject's signs and symptoms. Oxygen saturation and heart rate will be monitored using a pulse oximeter. Blood pressure will be assessed with a manual blood pressure cuff and stethoscope.

Participants will be screened at the first therapy session (T1) and at the last one (T2). Follow-up assessments will also take place at 1 month (T3) and 3 months (T4) after the end of treatment.

*Procedures During Treatment: The enrolled stroke patients will be randomly assigned to the Experimental Group (EG) or to the Control Group (CG). All patients will conduct gait therapy for at least 12 (subacute patients) or 18 (chronic patients) one-hour-sessions (about 3 times/ week).

Experimental Group (EG): Exoskeleton-Assisted Over ground Gait Training Sessions will begin with donning the Ekso device to ensure a proper fit. A physical therapist will check the subject for proper alignment of joints with the device and check for areas of increased pressure between the device and body. If necessary, additional padding will be added to ensure safety and comfort or the device configuration will be modified. During the initial sessions, skin checks will be occur more frequently at the end of each session to customize well the padding. Moreover, the identification of the best exoskeleton settings for each patient will be conducted for planning a customized and tailored robotic treatment.

During the treatment, the subject will be trained in interfacing with the exoskeleton Ekso with optimal postural alignment, and weight shifting strategies. No strength is required from the patient; only proper balance and weight shifts are required to achieve walking since steps are triggered by the user's lateral weight shift. Enrolled patients will undergo 60 minute long sessions of gait training using the powered wearable exoskeleton. Patients will conduct robotic training in conjunction with conventional physiotherapy training.

Control Group (CG): Traditional Over ground Gait Training The control group will perform 60 minute long sessions of Traditional Over ground Gait Training with a senior physiotherapist. In the starting phase, the gait task can be facilitated by the physiotherapist or by using aids, such as walkers, tripods etc.

Traditional Over ground Gait Training includes:

- Sit-to-Stand tasks

- Exercises for upright position control (right/left load shift): these tasks will allow to include people who are unable to walk in the CG.

- In case of patients able to walk or once this turns possible, they will be trained to re-learn a correct pattern of gait while walking over the ground.

CG patients will not use any other robots or treadmill for gait training. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03395717
Study type Interventional
Source IRCCS San Raffaele
Contact Marco Franceschini, MD
Phone +390652252402
Status Recruiting
Phase N/A
Start date March 16, 2016
Completion date December 31, 2019

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