Spinal Cord InjuryROBOSCIEKSONCT02065830
Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO).
A study testing EKSO in people with Spinal Cord Injury, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- EKSO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2014to Mar 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Cardiological or respiratory comorbidity.
- Hemodynamic instability.
- Presence of unhealed fractures.
- Presence of heterotopic ossification that may impede walking.
- Presence of osteoporosis.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS San Raffaele Pisana Roma
Roma, 00161
Fondazione Centri di Riabilitazione Padre Pio Onlus
San Giovanni Rotondo, Foggia
About this study
Official title: ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
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.
Read the detailed description
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
- Spinal Cord Injury
- Being tested
- EKSO
- Keywords
- Robot, Spinal Cord Injury, Gait, Quality of life, Rehabilitation, Lower Limb
- 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.
EKSODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot Safety and Efficacy | Experimental | 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. Receives: Device: EKSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
Change in score between 0 and 24 weeks. 3D Gait Analysis will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Measured: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Secondary outcomes (4)
Participant Satisfaction Questionnaire.
Change in score between 0 and 24 weeks. The 10 questions will be asked for each subject during and upon the completion of the active participation phase of the treatment.
Measured: Ekso training at 0 and 8 weeks, and 24-week follow-up
Change in blood pressure and heart rate during the training.
Blood pressure and heart rate will be monitorized every day during the training and the data will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Measured: Ekso training at 0 and 8 weeks, and 24-week follow-up.
6 minutes walking test.
Change in score between 0 and 24 weeks. The 6 minutes walking test will be collected in indoor and outdoor condition at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Measured: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Timed Up and Go test.
Change in score between 0 and 24 weeks. Timed Up and Go test will be collected in indoor and outdoor condition at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Measured: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrizio Sale, MD, Principal investigator, IRCCS San Raffaele Pisana Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065830
- Sponsor's protocol ID
- ROBOSCIEKSO
- Acronym
- ROBOSCIEKSO
- Status last verified
- Sep 2022
- First submitted
- 12 Feb 2014
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
PubMed 26818847
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
- ClinicalTrials.gov ID
- NCT02065830
- Acronym / sponsor ID
- ROBOSCIEKSO / ROBOSCIEKSO
- Conditions
- Spinal Cord Injury
- Keywords
- Robot, Spinal Cord Injury, Gait, Quality of life, Rehabilitation, Lower Limb
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Safety and Efficacy | Experimental | Device: EKSOThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Cardiological or respiratory comorbidity.
- Hemodynamic instability.
- Presence of unhealed fractures.
- Presence of heterotopic ossification that may impede walking.
- Presence of osteoporosis.
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 |
|---|---|---|
| EKSOThe 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. | Device | Robot Safety and Efficacy |
Primary outcome
Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
Time frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Change in score between 0 and 24 weeks. 3D Gait Analysis will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
4 secondary outcomes
Participant Satisfaction Questionnaire.
Time frame: Ekso training at 0 and 8 weeks, and 24-week follow-up
Change in blood pressure and heart rate during the training.
Time frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
6 minutes walking test.
Time frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Timed Up and Go test.
Time frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Derived from this study: PubMed 26818847Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
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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.
Patrizio Sale, MD principal investigator
IRCCS San Raffaele Pisana Roma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EKSO in people with Spinal Cord Injury, run by IRCCS San Raffaele Roma at 2 sites 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months. (time frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065830, which also lists 1 linked publication.
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 14 Sep 2022.