StrokeERIGO®LIFENCT02268266
ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization
A study testing Erigo in people with Stroke and Spinal Cord Injury, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.
Trial summary
Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spinal Cord Injury
- What is being tested?
- Erigo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2010to Mar 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum 18 years old
- normal response to verbal instructions
- oxygen saturation of the blood at least 92%
- healthy german speaking men and women
- non-smoker
- heartbeat 40-100
- systolic blood pressure 120 to 220 mmHg
- in patients: post acute phase: stroke or other neurological functional disorder
Who cannot join
- severe contraction in the legs (Ashworth >3)
- pregnancy
- acute pain syndrome
- severe cardio-pulmonary disease
- history of orthostatic dysregulation
- thrombophlebitis
Show all 12Show fewer
- diabetes
- renal disease
- contraindication for electric stimulation (instable epilepsy, cancer, pacemaker, palliative care)
- weight > 120kg
- height > 210 cm
- skin lesions on legs
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Zürcher Höhenklinik Wald
Wald, Canton of Zurich, 8636
ETH Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: ERIGO® Life - Study of Cardiovascular Parameters and Other Physiologic Parameters Under Verticalization and Simultaneous Mobilization of the Leg on Neurological Patients and Healthy Subjects
Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation).
Read the detailed description
In early rehabilitation of neurological patients, safe mobilization and intensive sensorimotor stimulation are key factors for therapeutic success. Early activation and stimulation of the patient intend enhancement of neuroplasticity and recovery. Furthermore, it improves the patient's communication and cooperation skills and counteracts secondary damages due to immobilization.
The study combines gradual verticalization during monitoring of vital parameters, with cyclic leg movement and foot loading. The table to ensures the necessary safety for the stabilization of the patient in the upright position. The patient stimulation is additionally enhanced by synchronized functional electrical stimulation (FES). By providing a safe solution for early mobilization, the Erigo counteracts the negative effects of immobility and accelerates the recovery process through intensive sensorimotor stimulation. It is the first choice therapy device for the early and safe mobilization of severely impaired, bed-ridden patients even in acute care.
- Conditions
- Stroke, Spinal Cord Injury
- Being tested
- Erigo
- Keywords
- brain injury, early rehabilitation, tilt table
- Medical subject headings
- Stroke, Spinal Cord Injuries, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErigoDevice
Also called Erigo rehabilitation bed from Hocoma AG, Switzerland.
The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Other | Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects Receives: Device: Erigo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event as a measure of safety and tolerability
Control of cardiovascular parameters at desired ranges at healthy and at patients
Measured: Up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startApr 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Zuercher Hoehenklinik Wald, Hocoma AG, Switzerland
- Responsible party
- Principal investigator, Verena Klamroth, Swiss Federal Institute of Technology
- Investigators
- Robert Riener, Prof.Dr.-Ing, Principal investigator, Swiss Federal Institut of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268266
- Sponsor's protocol ID
- ERIGO LIFE StV 22_2009
- Acronym
- ERIGO®LIFE
- Status last verified
- Nov 2015
- First submitted
- 31 Jul 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERIGO® Life - Study of Cardiovascular Parameters and Other Physiologic Parameters Under Verticalization and Simultaneous Mobilization of the Leg on Neurological Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02268266
- Acronym / sponsor ID
- ERIGO®LIFE / ERIGO LIFE StV 22_2009
- Conditions
- Stroke, Spinal Cord Injury
- Keywords
- brain injury, early rehabilitation, tilt table
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Zuercher Hoehenklinik Wald, Hocoma AG, Switzerland
- Study start
- Apr 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Oct 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.
Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation).
Detailed description
In early rehabilitation of neurological patients, safe mobilization and intensive sensorimotor stimulation are key factors for therapeutic success. Early activation and stimulation of the patient intend enhancement of neuroplasticity and recovery. Furthermore, it improves the patient's communication and cooperation skills and counteracts secondary damages due to immobilization.
The study combines gradual verticalization during monitoring of vital parameters, with cyclic leg movement and foot loading. The table to ensures the necessary safety for the stabilization of the patient in the upright position. The patient stimulation is additionally enhanced by synchronized functional electrical stimulation (FES). By providing a safe solution for early mobilization, the Erigo counteracts the negative effects of immobility and accelerates the recovery process through intensive sensorimotor stimulation. It is the first choice therapy device for the early and safe mobilization of severely impaired, bed-ridden patients even in acute care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Other | Device: ErigoEarly mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- minimum 18 years old
- normal response to verbal instructions
- oxygen saturation of the blood at least 92%
- healthy german speaking men and women
- non-smoker
Key exclusion criteria (12 listed)
- severe contraction in the legs (Ashworth >3)
- pregnancy
- acute pain syndrome
- severe cardio-pulmonary disease
- history of orthostatic dysregulation
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 |
|---|---|---|
| ErigoAlso: Erigo rehabilitation bed from Hocoma AG, Switzerland.The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation | Device | Single-arm study |
Primary outcome
Number of participants with adverse event as a measure of safety and tolerability
Time frame: Up to 8 hours
Control of cardiovascular parameters at desired ranges at healthy and at patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
Robert Riener, Prof.Dr.-Ing principal investigator
Swiss Federal Institut of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erigo in people with Stroke and Spinal Cord Injury, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 18 Nov 2015. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse event as a measure of safety and tolerability (time frame: Up to 8 hours). 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 18 Nov 2015.