Spinal Cord InjuriesNCT03443700
Randomized Controlled Trial on Robotic Exoskeleton in Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity
A study testing EKSO-GT and Standard neurorehabilitation locomotor training in people with Spinal Cord Injuries, run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- EKSO-GT and Standard neurorehabilitation locomotor training
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI due to traumatic or vascular etiology;
- Incomplete motor SCI (C or D in ASIA Impairment Scale);
- T1-L1 (included) neurological level;
- 1-5 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;
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- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL di Bologna, Istituto delle Scienze Neurologiche di Bologna (IRCCS ISNB)
Bologna, BO, 40139
Elena Antelmi, MD, +39-3293526335, elenaantelmi@gmail.com
About this study
Official title: Randomized Controlled Trial on Rehabilitation Training With a Robotic Anthropomorphic Exoskeleton in Patients With Motor Incomplete Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity Indicators
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:
Read more
- 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;
- 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.
Read the detailed 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- EKSO-GT, Standard neurorehabilitation locomotor training
- Keywords
- SCI, gait, incomplete motor SCI, robotic gait training, locomotor training, walking training, rehabilitation, exoskeleton, EKSO, EKSO-GT, neuroplasticity, brain cortical plasticity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EKSO-GTDevice
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).
Standard neurorehabilitation locomotor trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| sLT | Active comparator | Standard neurorehabilitation locomotor training during the whole study period (8 weeks). Receives: Procedure: Standard neurorehabilitation locomotor training |
| sLT + EX-T | Experimental | 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. Receives: Device: EKSO-GT; Procedure: Standard neurorehabilitation locomotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking performance
10-meter walk test
Measured: Baseline (initial visit post-randomization); week 4
Secondary outcomes (14)
Change in walking performance
10-meter walk test
Measured: Baseline (initial visit post-randomization); week 8
Change in walking endurance
6-minute walk test
Measured: Baseline (initial visit post-randomization); week 4; week 8
Change in functional walking capacity
Walking Index for Spinal Cord Injury II (WISCI II)
Measured: Baseline (initial visit post-randomization); week 4; week 8
Change in spasticity
Modified Ashworth Scale
Measured: Baseline (initial visit post-randomization); week 4; week 8
Change in pain
Numeric Rating Scale (NRS)
Measured: 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)
Measured: 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
Measured: Baseline (initial visit post-randomization); week 4; week 8
Change in lower limbs muscle activation pattern
Gait Dynamic Electromyography (DEMG)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline (initial visit post-randomization); after the first locomotor training session; week 4
Change in synaptic potentiation (neuroprosthetic learning)
Analysis of EEG coherence signal
Measured: 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)
Measured: Baseline (initial visit post-randomization); week 4; week 8
Evaluation of patient's satisfaction for the training received
Ad-hoc questionnaire
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start10 Dec 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- IRCCS Istituto delle Scienze Neurologiche di Bologna, University of Bologna, Montecatone Rehabilitation Institute S.p.A., Imola (Italy), IRCCS Fondazione S. Lucia, Roma (Italy), IRCCS Fondazione Ospedale S. Camillo, Venezia (Italy)
- Responsible party
- Sponsor
- Investigators
- Elena Antelmi, MD, Principal investigator, IRCCS - ISNB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443700
- Sponsor's protocol ID
- CE-19072
- Other IDs
- 347-2019-DISP-AUSLBO
- Status last verified
- Dec 2021
- First submitted
- 16 Feb 2018
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Rehabilitation Training With a Robotic Anthropomorphic Exoskeleton in Patients With Motor Incomplete Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity Indicators
- ClinicalTrials.gov ID
- NCT03443700
- Acronym / sponsor ID
- CE-19072
- Conditions
- Spinal Cord Injuries
- Keywords
- SCI, gait, incomplete motor SCI, robotic gait training, locomotor training, walking training, rehabilitation, exoskeleton
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- IRCCS Istituto delle Scienze Neurologiche di Bologna, University of Bologna, Montecatone Rehabilitation Institute S.p.A., Imola (Italy), IRCCS Fondazione S. Lucia, Roma (Italy), IRCCS Fondazione Ospedale S. Camillo, Venezia (Italy)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| sLT | Active comparator | Procedure: Standard neurorehabilitation locomotor trainingStandard neurorehabilitation locomotor training during the whole study period (8 weeks). |
| sLT + EX-T | Experimental | Device: EKSO-GT, Procedure: Standard neurorehabilitation locomotor trainingStandard 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- SCI due to traumatic or vascular etiology;
- Incomplete motor SCI (C or D in ASIA Impairment Scale);
- T1-L1 (included) neurological level;
- 1-5 years since injury;
- Functional gait ability (also with braces or orthoses);
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EKSO-GTEach 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). | Device | sLT + EX-T |
| Standard neurorehabilitation locomotor trainingNeurorehabilitation 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. | Procedure or surgery | sLT, sLT + EX-T |
Primary outcome
Change in walking performance
Time frame: Baseline (initial visit post-randomization); week 4
10-meter walk test
14 secondary outcomes
Change in walking performance
Time frame: Baseline (initial visit post-randomization); week 8
Change in walking endurance
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in functional walking capacity
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in spasticity
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in pain
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
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in lower limbs muscle strength
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in lower limbs muscle activation pattern
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Change in entity of neuronal plasticity and cortical remodelling of motor cortical areas
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
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4; week 8
Change in synaptic potentiation (neuroprosthetic learning)
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4
Change in synaptic potentiation (neuroprosthetic learning)
Time frame: Baseline (initial visit post-randomization); after the first locomotor training session; week 4
Change in brain anatomy and cortical structure
Time frame: Baseline (initial visit post-randomization); week 4; week 8
Evaluation of patient's satisfaction for the training received
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Antelmi, MD principal investigator
IRCCS - ISNB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EKSO-GT and Standard neurorehabilitation locomotor training in people with Spinal Cord Injuries, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Antelmi, MD (+39-3293526335, elenaantelmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking performance (time frame: Baseline (initial visit post-randomization); week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.