Clinical trial NCT03395717: Stroke Rehabilitation With Exoskeleton-assisted Gait.
Official title: Stroke Rehabilitation With Exoskeleton-assisted Gait: Clinical and Neuromuscular Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Stroke
Acute Stroke
Chronic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mild Stroke
Keywords: Stroke
Robot
Hemiparesis
Gait Training
Rehabilitation
Exoskeleton
Functional Recovery
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Ospedale Riabilitativo di Alta Specializzazione Motta Di Livenza -Treviso
name: Fondazione Centri di Riabilitazione Padre Pio Onlus
name: Villa Beretta Rehabilitation Center
name: Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Foligno - Trevi
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: Kos Care - Istituto Santo Stefano Porto Potenza
name: Kos Care - Istituto Santo Stefano Ancona
First posted: 2018-01-10
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* stroke or similar neurological pathologies:

  * 2 weeks up to 6 months after the acute event (subacute patients);
  * 6 months or more after the acute event (chronic patients)
* age between 18-80 years;
* ability to fit into the device and joint motion which allows gait with it;
* ability to tolerate upright standing for 30 seconds even with upper limbs support;
* sufficient upper extremity strength and balance which allow gait with device;
* ability and willing to give written consent and comply with the study procedures, including the follow-up visits.

Exclusion Criteria:

* subject's height shorter than 150 cm or taller than 190 cm;
* subject's weight greater than 100 kg;
* contractures of the hip, knee, or ankle joints that might limit normal Range of Motion during gait;
* medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
* history of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device;
* cognitive and/or communicative disability (e.g. due to brain injury): patients must be able to follow directions and demonstrate learning skills;
* pregnancy ;
* untreated Deep Vein Thrombosis (DVT).

Primary outcomes:
measure: Change in 6 Minute Walk Test (6MWT)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
Secondary outcomes:
measure: Change in 10 Meter Walk Test (10MWT)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Time Up And Go (TUG)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Trunk Control Test (TCT)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Motricity Index (MI)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Functional Ambulation Classification (FAC)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Handicap Walking Scale (WHS)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
measure: Change in Barthel Index (BI
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
Other outcomes:
measure: Change in Numeric Rating SCale (NRS)
timeFrame: Session 1 (baseline), Session 12 (week 4)
measure: Change in surface ElectroMyoGraphy (sEMG)
timeFrame: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
Locations:
city: Costa Masnaga
country: Italy
facility: Villa Beretta
city: Foligno
country: Italy
facility: Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Trevi
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
city: San Giovanni Rotondo
country: Italy
facility: Fondazione Centri di Riabilitazione Padre Pio Onlus
Study officials:
affiliation: IRCSSSRaffaele
name: Marco Franceschini, MD
role: STUDY_DIRECTOR
affiliation: IRCSSSRaffaele
name: Michela Goffredo, Phd
role: PRINCIPAL_INVESTIGATOR
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