Stroke Rehabilitation With Exoskeleton-assisted Gait.

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.

Conditions

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

Interventions

DEVICE

Exoskeleton-Assisted Gait Training

Sponsors & Collaborators

• Ospedale Riabilitativo di Alta Specializzazione Motta Di Livenza -Treviso

  collaborator UNKNOWN

• Fondazione Centri di Riabilitazione Padre Pio Onlus

  collaborator UNKNOWN

• Villa Beretta Rehabilitation Center

  collaborator OTHER

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

  collaborator UNKNOWN

• IRCCS Sacro Cuore Don Calabria di Negrar

  collaborator OTHER

• Kos Care - Istituto Santo Stefano Porto Potenza

  collaborator UNKNOWN

• Kos Care - Istituto Santo Stefano Ancona

  collaborator UNKNOWN

• IRCCS San Raffaele Roma

  lead OTHER

Principal Investigators

• Marco Franceschini, MD · IRCSSSRaffaele

• Michela Goffredo, Phd · IRCSSSRaffaele

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-16

Primary Completion

2018-11-01

Completion

2020-03-30

Countries

• Italy

Study Locations