Stroke Rehabilitation With Exoskeleton-assisted Gait.

NCT ID: NCT03395717

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-16
• Study Completion Date: 2020-03-30

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.

Conditions

Severe Stroke; Acute Stroke; Chronic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mild Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exoskeleton-Assisted Gait Training

Patients conduct sessions of gait training, each lasting 60 minutes, using the powered wearable exoskeleton (Ekso) in addition to conventional therapy. Before the treatment's beginning, a PT checks the correct alignment of the subject's joints with Ekso and the areas of greater pressure between body's skin and device, to set a proper Ekso fit as to customize the padding as well. The best individualized exoskeleton settings should be verified to plan a tailored robotic treatment. During treatment, subjects are trained to interface with the Ekso, with optimal postural arrangement and weight shifting strategies. No strength is required from the patient; only an appropriate balance and weight shifts are necessary to achieve walking, since steps are triggered by the user's lateral weight shift.

Group Type: EXPERIMENTAL

Exoskeleton-Assisted Gait Training

Intervention Type: DEVICE

Traditional Over ground Gait Training

The Control Group (CG) performs 60 minutes. lasting sessions of Traditional Over ground Gait Training with a senior PT. In the starting phase, the gait task facilitation is allowed by the Pt's assistance or by using aids, such as walkers, tripods etc.

Traditional Over ground Gait Trainings include:

• 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exoskeleton-Assisted Gait Training

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Riabilitativo di Alta Specializzazione Motta Di Livenza -Treviso

UNKNOWN

Sponsor Role: collaborator

Fondazione Centri di Riabilitazione Padre Pio Onlus

UNKNOWN

Sponsor Role: collaborator

Villa Beretta Rehabilitation Center

OTHER

Sponsor Role: collaborator

Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Foligno - Trevi

UNKNOWN

Sponsor Role: collaborator

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: collaborator

Kos Care - Istituto Santo Stefano Porto Potenza

UNKNOWN

Sponsor Role: collaborator

Kos Care - Istituto Santo Stefano Ancona

UNKNOWN

Sponsor Role: collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Franceschini, MD

Role: STUDY_DIRECTOR

IRCSSSRaffaele

Michela Goffredo, Phd

Role: PRINCIPAL_INVESTIGATOR

IRCSSSRaffaele

Locations

Villa Beretta

Costa Masnaga, , Italy

Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Trevi

Foligno, , Italy

IRCCS San Raffaele Pisana

Roma, , Italy

Fondazione Centri di Riabilitazione Padre Pio Onlus

San Giovanni Rotondo, , Italy

Countries

Italy

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Other Identifiers

RP 10/15

Identifier Type: -

Identifier Source: org_study_id