NCT03395717: EKSOGAIT

Stroke Rehabilitation With Exoskeleton-assisted Gait.

Completed NA Last updated 10 April 2024

What this trial tests

NA trial testing Exoskeleton-Assisted Gait Training in Severe Stroke in 162 participants. Completed in 30 March 2020.

Timeline

16 March 2016

Primary endpoint
1 November 2018

30 March 2020

Quick facts

Lead sponsor	IRCCS San Raffaele Roma
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	162
Start date	16 March 2016
Primary completion	1 November 2018
Estimated completion	30 March 2020
Sites	4 locations across Italy

Drugs / interventions tested

• Exoskeleton-Assisted Gait Training

Conditions studied

• Severe Stroke — all drugs for Severe Stroke →
• Acute Stroke — all drugs for Acute Stroke →
• Chronic Stroke — all drugs for Chronic Stroke →
• Cerebrovascular Disorders — all drugs for Cerebrovascular Disorders →

Sponsor

IRCCS San Raffaele Roma — full company profile →

Who can join

Adults 18 to 80, any sex, with Severe Stroke or Acute Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electromechanical-assisted training for walking after stroke.
   Mehrholz J, Thomas S, Kugler J, Pohl M, et al · · 2020 · cited 146× · PMID 33091160 · DOI 10.1002/14651858.cd006185.pub5
2. Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects.
   Molteni F, Guanziroli E, Goffredo M, Calabrò RS, et al · · 2021 · cited 43× · PMID 33466749 · DOI 10.3390/brainsci11010104
3. Functional Gait Recovery after a Combination of Conventional Therapy and Overground Robot-Assisted Gait Training Is Not Associated with Significant Changes in Muscle Activation Pattern: An EMG Preliminary Study on Subjects Subacute Post Stroke.
   Infarinato F, Romano P, Goffredo M, Ottaviani M, et al · · 2021 · cited 15× · PMID 33915808 · DOI 10.3390/brainsci11040448
4. Barriers to sEMG Assessment During Overground Robot-Assisted Gait Training in Subacute Stroke Patients.
   Goffredo M, Infarinato F, Pournajaf S, Romano P, et al · · 2020 · cited 12× · PMID 33193001 · DOI 10.3389/fneur.2020.564067