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Stroke Rehabilitation With Exoskeleton-assisted Gait.

NCT03395717 · IRCCS San Raffaele Roma · Updated 10 April 2024

What is being tested
Exoskeleton-Assisted Gait Training
For
Severe Stroke; Acute Stroke; Chronic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mild Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 162 people. The full rules are on the registry page.
Where
Italy (4 sites)
When
Starts or started 16 March 2016, ends 30 March 2020. Registered 10 Jan 2018.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT03395717

Sites

  • Villa BerettaCosta Masnaga, Italy
  • Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) TreviFoligno, Italy
  • IRCCS San Raffaele PisanaRoma, Italy
  • Fondazione Centri di Riabilitazione Padre Pio OnlusSan Giovanni Rotondo, Italy