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

NCT03443700 | Unknown FDA Device

• 2 other identifiers: CE-19072347-2019-DISP-AUSLBO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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. 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. 2.to investigate the presence and persistence of brain neuronal plasticity and cortical remodeling mechanisms underlying the robotic rehabilitation approach.

Conditions

Spinal Cord Injuries

Keywords

SCI; gait; incomplete motor SCI; robotic gait training; locomotor training; walking training; rehabilitation; exoskeleton; EKSO; EKSO-GT; neuroplasticity; brain cortical plasticity

Outcome Measures

Primary Outcomes (1)

• Change in walking performance

  10-meter walk test

  Baseline (initial visit post-randomization); week 4

Secondary Outcomes (14)

• Change in walking performance

  Baseline (initial visit post-randomization); week 8

• Change in walking endurance

  Baseline (initial visit post-randomization); week 4; week 8

• Change in functional walking capacity

  Baseline (initial visit post-randomization); week 4; week 8

• Change in spasticity

  Baseline (initial visit post-randomization); week 4; week 8

• Change in pain

  Baseline (initial visit post-randomization); every day, twice a day for the whole study period; overall appraisal at week 4 and week 8

Study Arms (2)

sLT

ACTIVE COMPARATOR

Standard neurorehabilitation locomotor training during the whole study period (8 weeks).

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.

Device: EKSO-GT; Procedure: Standard neurorehabilitation locomotor training

Interventions

EKSO-GT DEVICE

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).

sLT + EX-T

Standard neurorehabilitation locomotor training PROCEDURE

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.

sLT; sLT + EX-T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCI due to traumatic or vascular etiology;
• Incomplete motor SCI (C or D in ASIA Impairment Scale);
• T1-L1 (included) neurological level;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Usl di Bologna: lead
• IRCCS Institute of Neurological Sciences of Bologna (Italy): collaborator
• Department of Biomedical and Neuromotor Sciences of the University of Bologna (Italy): collaborator
• Montecatone Rehabilitation Institute S.p.A., Imola (Italy): collaborator
• IRCCS Fondazione S. Lucia, Roma (Italy): collaborator
• IRCCS Fondazione Ospedale S. Camillo, Venezia (Italy): collaborator

Study Sites (1)

Azienda USL di Bologna, Istituto delle Scienze Neurologiche di Bologna (IRCCS ISNB)

Bologna, BO, 40139, Italy

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Elena Antelmi, MD

  IRCCS - ISNB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Antelmi, MD

CONTACT

+39-3293526335; elenaantelmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the use of an evident Medical Device (exoskeleton), enrolled subjects cannot be blind about their assignment group, however objective and standardized clinical measure scales will be employed; moreover, assessments (also neurophysiological and neuroimaging ones) will be conducted by blind experts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 23, 2018
• Study Start: December 10, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

IT (1)