Randomized Controlled Trial on Robotic Exoskeleton in Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity

Summary

The recent introduction of robotics for locomotor training in paraplegic patients, and in particular the use of anthropomorphic exoskeletons, has opened new frontiers in rehabilitation. Existing literature, though encouraging, is still scarce and studies demonstrating efficacy are highly heterogeneous and have a small sample size. Evidence is also needed about cortical plasticity after SCI, in conjunction with the use of innovative rehabilitation devices, through indicators like neurophysiological and neuroradiological markers, as the knowledge of such mechanisms is crucial to improve clinical outcomes. Cortical circuits controlling prosthetic devices are different from those controlling normal parts of the body and remodeling mechanisms following prosthetic use have been documented, but in conditions other than SCI.

The aims of this randomized controlled trial, with a 2-arm parallel-group design, are:

1. to evaluate and quantify the efficacy of locomotor rehabilitation with a robotic anthropomorphic exoskeleton (EKSO-GT) in terms of clinical and functional outcomes, and the persistence of such efficacy;
2. to investigate the presence and persistence of brain neuronal plasticity and cortical remodeling mechanisms underlying the robotic rehabilitation approach.

Fifty patients will be recruited and randomly assigned to 2 treatment arms. Both groups will follow a program of standard locomotor rehabilitation for 8 weeks. One group will also undergo an overground locomotor training with the EKSO-GT during the first 4 weeks.

Conditions

• Spinal Cord Injuries

Interventions

DEVICE

EKSO-GT

Each rehabilitation session with EKSO-GT will last (operating time) 30-40 minutes. Such training will be carried out for 3 sessions per week, during the first 4 consecutive weeks of the study period (i.e. 12 total sessions per patient).

PROCEDURE

Standard neurorehabilitation locomotor training

Neurorehabilitation locomotor training will be performed according to standardized protocols shared within the scientific community, during the whole 8-week study period, 5 times per week, twice a day, for a total of about 2,5 hours per day.

Sponsors & Collaborators

• IRCCS Institute of Neurological Sciences of Bologna (Italy)

  collaborator UNKNOWN

• Department of Biomedical and Neuromotor Sciences of the University of Bologna (Italy)

  collaborator UNKNOWN

• Montecatone Rehabilitation Institute S.p.A., Imola (Italy)

  collaborator UNKNOWN

• IRCCS Fondazione S. Lucia, Roma (Italy)

  collaborator UNKNOWN

• IRCCS Fondazione Ospedale S. Camillo, Venezia (Italy)

  collaborator UNKNOWN

• Azienda Usl di Bologna

  lead OTHER_GOV

Principal Investigators

• Elena Antelmi, MD · IRCCS - ISNB

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-10

Primary Completion

2022-11-30

Completion

2022-11-30

FDA Device

Yes

Countries

• Italy

Study Locations