Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Locomotor Training With Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting

NCT02600013

Spinal Cord Injuries

COMPLETED

Performance Attributes and User Progression While Using Ekso

NCT02132702

Spinal Cord Injury

COMPLETED NA

Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases

NCT06894160

Neuromuscular Disorders

NOT_YET_RECRUITING NA

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

NCT03443700

Spinal Cord Injuries

UNKNOWN NA

Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury

NCT04250688

Spinal Cord Injuries

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, 30 participants with chronic spinal cord injury will undergo a 8-week training schedule for ambulation with the EKSO™ device.

Ekso™ is a wearable bionic suit which enables individuals with any amount of lower extremity weakness to stand up and walk over ground with a natural, full weight bearing, reciprocal gait. Walking is achieved by the user's weight shifts to activate sensors in the device which initiate steps. Battery-powered motors drive the legs, replacing deficient neuromuscular function.

Ekso provides functional based rehabilitation, over ground gait training, and upright, weight bearing exercise unlike any other. It has been designed for the needs of busy therapists treating a wide range of patients in a single day. The suit is strapped over the users´ clothing with easy adjustments to transition between patients in as little as five minutes.

Before, during and after training sessions the subjects will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot Safety and Efficacy

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling.

The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.

Group Type EXPERIMENTAL

EKSO

Intervention Type DEVICE

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling.

The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EKSO

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling.

The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic motor complete or incomplete cervical and thoracic (C7-T12) spinal cord injury.
* Skin integrity.
* Adequate hip, knee and ankle range of motion.
* Spasticity level of 3 or less (Ashworth scale).

Exclusion Criteria

* Cardiological or respiratory comorbidity.
* Hemodynamic instability.
* Presence of unhealed fractures.
* Presence of heterotopic ossification that may impede walking.
* Presence of osteoporosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes