An interventional study of EKSO-GT and Standard neurorehabilitation locomotor training in Spinal Cord Injuries, sponsored by Azienda Usl di Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by Azienda Usl di Bologna · Not applicable, Interventional, and Treatment
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:
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.
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.
Exclusion Criteria:
Standard neurorehabilitation locomotor training during the whole study period (8 weeks).
Procedure: Standard neurorehabilitation locomotor training
Standard neurorehabilitation locomotor training (sLT) during the whole study period (8 weeks), plus a training with a new-generation robotic anthropomorphic exoskeleton (EKSO-GT locomotor training) during the first 4 study weeks.
Device: EKSO-GT · Procedure: Standard neurorehabilitation locomotor training
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).
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.
Change in walking performance
10-meter walk test
Time frame: Baseline (initial visit post-randomization); week 4
Change in walking performance
10-meter walk test
Time frame: Baseline (initial visit post-randomization); week 8
Change in walking endurance
6-minute walk test
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in functional walking capacity
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in spasticity
Modified Ashworth Scale
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in pain
Numeric Rating Scale (NRS)
Time frame: Baseline (initial visit post-randomization); every day, twice a day for the whole study period; overall appraisal at week 4 and week 8
Change in mood state
Profile of Mood States questionnaire (POMS)
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in lower limbs muscle strength
Lower Extremity Motor Score (LEMS) of the American Spinal Injury Association (ASIA) Impairment Scale
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in lower limbs muscle activation pattern
Gait Dynamic Electromyography (DEMG)
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in entity of neuronal plasticity and cortical remodelling of motor cortical areas
Change in short-term intracortical inhibition through Motor Evoked Potentials (PEMs) elicited by Transcranial Magnetic Stimulation (TMS)
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4; week 8
Change in entity of neuronal plasticity and cortical remodelling of sensory cortical areas
Somatosensory Evoked Potentials (SSEs) at cortical level
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4; week 8
Change in synaptic potentiation (neuroprosthetic learning)
Analysis of slow-wave oscillations with Electroencephalographic (EEG) polysomnography (PSG)
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4
Change in synaptic potentiation (neuroprosthetic learning)
Analysis of EEG coherence signal
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4
Change in brain anatomy and cortical structure
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Evaluation of patient's satisfaction for the training received
Ad-hoc questionnaire
Time frame: Week 4
Plan to share: Undecided
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Azienda Usl di Bologna