Status:
UNKNOWN
Randomized Controlled Trial on Robotic Exoskeleton in Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity
Lead Sponsor:
Azienda Usl di Bologna
Collaborating Sponsors:
IRCCS Institute of Neurological Sciences of Bologna (Italy)
Department of Biomedical and Neuromotor Sciences of the University of Bologna (Italy)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 liter...
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 ...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03443700
Start Date
December 10 2020
End Date
November 1 2022
Last Update
December 16 2021
Active Locations (1)
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1
Azienda USL di Bologna, Istituto delle Scienze Neurologiche di Bologna (IRCCS ISNB)
Bologna, BO, Italy, 40139