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

  • STATUS
    Recruiting
  • End date
    Nov 19, 2022
  • participants needed
    50
  • sponsor
    Azienda Usl di Bologna
Updated on 26 February 2022
spinal cord
spinal cord disorder
locomotor training

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.

Description

The increasing incidence of incomplete Spinal Cord Injury (SCI) has raised new rehabilitation challenges. Recovery of walking is one of the top priorities in SCI persons and growing efforts have been pursued aimed at identifying effective alternative techniques for improving gait performance.

Standard rehabilitation approach has been so far the most widely used, but the recent introduction of anthropomorphic exoskeletons may open new frontiers in the field. Anthropomorphic exoskeletons have been developed to assist SCI patients with mobility, but there is also a certain optimism that they may have potentialities to improve walking patterns of incomplete SCI persons after a rehabilitation period with such devices is terminated. So far, however, while different systematic reviews and meta-analyses have reported on the safety of the training with such exoskeletons, there are no significant Fiftystudies on its efficacy. Along with this, central mechanisms underlying the anatomical and functional changes induced by these approaches have never been investigated in SCI.

This longitudinal randomized controlled trial, with a 2-arm parallel group design, aims at evaluating the efficacy of the training with an anthropomorphic, robotized exoskeleton (EKSO-GT, by Ekso Bionics), as "add-on" to the standard locomotor rehabilitation, in improving walking performance, when compared to the standard locomotor rehabilitation alone, in a population of patients with non-acute motor incomplete SCI. Along with this and other clinical outcomes, neurophysiological and structural markers of Central Nervous System (CNS) plasticity will be explored, aimed at capturing mechanisms underlying how anthropomorphic exoskeletons affect CNS plasticity.

Fifty patients will be recruited in 3 Italian rehabilitation hospitals setting and assigned to 2 groups, with an allocation ratio of 1:1, through a block randomization approach. One group will perform a 4-week standard locomotor training (sLT) alone, while the other will perform a 4-week period sLT plus a training with the EKSO-GT (sLT + EX-T). Afterwards, both groups will undergo a further 4-week sLT alone.

Patients will be evaluated at several time points (always when the exoskeleton is not worn): clinical outcomes will be assessed by means of clinical examinations, standardized tests and validated scales; neurophysiological modulations will be evaluated by means of paired Motor and Sensory Evoked Potentials and a study of Electroencephalographic (EEG) slow waves oscillations and signal coherence during sleep; anatomical and structural cortical modifications will be studied with brain functional Magnetic Resonance Imaging (fMRI).

It is expected that the overground locomotor training with a new-generation exoskeleton, as "add-on" to standard locomotor training, can further improve clinical outcomes (especially walking performance) in the studied population, and that such clinical improvements are underlined by mechanisms modulating synaptic plasticity occurring also at the CNS level.

Details
Condition Spinal Cord Injuries
Treatment EKSO-GT, Standard neurorehabilitation locomotor training
Clinical Study IdentifierNCT03443700
SponsorAzienda Usl di Bologna
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

SCI due to traumatic or vascular etiology
Incomplete motor SCI (C or D in ASIA Impairment Scale)
T1-L1 (included) neurological level
-5 years since injury
Functional gait ability (also with braces or orthoses)
Sufficient Range of Motion (ROM) of lower limbs joints to achieve a reciprocal gait pattern and allow transition from sitting to vertical position
Stable clinical conditions
Minimum height of 157 cm
Maximum height of 188 cm
Maximum weight of 100 Kg
Maximum intertrochanteric distance of 46 cm
Cognitive integrity and full collaboration of the subject
Specific research informed consent signed

Exclusion Criteria

Intensive walking rehabilitation training undergone in the last 3 months
Previous use of a robotic exoskeleton
Instability or major deformity of the spine
Lower limbs joints instability
Indication to spinal orthosis
Uncontrolled spasticity (score > 3 of the Modified Ashworth Scale) in the majority of the muscle groups of the lower limbs
History of traumatic brain injury
Recent significant bone fractures, traumatic and/or pathological for the required training
Presence of neurogenic paraosteoarthropathies (POAN) at the onset or phlogistic phase
Discrepancy in femurs length (> 1.3 cm) and legs length (> 1.9 cm)
Symptomatic orthostatic hypotension
Severe and recurrent uncontrolled autonomic dysreflexia
Cardiopulmonary comorbidities limiting physical effort
Skin lesions that can interfere with the study rehabilitation trainings
Documented psychiatric pathology
Contraindications to fMRI and polygraphic EEG execution
Contraindications to TMS
Ongoing pregnancy
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