Brain InjuriesNCT02700399
Study of Pulse Pressure During Tilttable and Erigo® in Adult Patients With Acquired Brain Injury
A study testing Erigo® Hocoma and Traditional tilt table from Rehab-Care in people with Brain Injuries and Hypotension, Orthostatic, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if the pulse pressure changes are different whether patients are training in a traditional tilt table as compared to a robotic assisted tilt table, which induces leg movement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Hypotension, Orthostatic, Syncope
- What is being tested?
- Erigo® Hocoma and Traditional tilt table from Rehab-Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2015to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Already being treated with traditional tilttable and must be able to benefit from Erigo® treatment from a clinicians view
- Acquired brain injury as primary diagnose
- Must have Rancho Los Amigo Scale score of minimum 1 to maximum 6 on the day of inclusion
Who cannot join
- Not on mechanical ventilation
- New cerebral, cardiological or other medical problems/emergencies between the 2 interventions
- Change in cardiac medications between interventions
- Patient must not have independent gait function immediately before trial
- must not have EFA(Early Functional abilities) part score > 4 in the section "Standing", assessed by the treating physiotherapist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Crossover Study of Pulse Pressure on Respectively Tilt Table With Integrated Stepping Function (Erigo®) and Traditional Tilt Table in Adult Patients With Acquired Brain Injury
The purpose of this study is to determine if the pulse pressure changes are different whether patients are training in a traditional tilt table as compared to a robotic assisted tilt table, which induces leg movement.
Read the detailed description
The trial takes place in a non private hospital in Denmark. Patients are recruited from two wards treating patients with severe brain injury, and all patients admitted in the study period are considered in regards to inclusion or exclusion. Patients are included via closest relatives accept, and the patients GP(General Practitioner). Any adverse effect or event will be reported to the local ethics committee. All data will be collected simultaneously with the interventions. Some data will be directly recorded via monitor output, and some data will be directly inputted in Epidata, while trial takes place.
Sample size has been calculated to be between 10 and 60 individuals depending on the actual difference. Beyond 60 included individuals the clinical relevance of a statistical significant result is no longer apparent. If any individual variables are noncomplete, an analysis of the subjects with missing data, will be undertaken.
The statistical analyses planned follows the general crossover design using an approach considering 2 treatment and 2 periods. Patients are cluster randomized in clusters of 4, to be treated with one or the other intervention first.
Intervention A:
Traditional tilt table. measurements at 0 degrees 30 deg. 60. deg. and at return to 0 deg.
Intervention B:
Erigo® tilttable, with measurements as in intervention A. During the intervention the step frequency of the Erigo® i set at 48 steps/min.
Between the two periods a wash out period of at least ½ hour and maximum 2 hours are planned.
Primary outcome is derived from noninvasive BP measurements.
- Conditions
- Brain Injuries, Hypotension, Orthostatic, Syncope
- Being tested
- Erigo® Hocoma, Traditional tilt table from Rehab-Care
- Keywords
- Rehabilitation
- Medical subject headings
- Brain Injuries, Hypotension, Orthostatic, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erigo® HocomaDevice
Robotics assisted tilt table, without functional electrical stimulation
Traditional tilt table from Rehab-CareDevice
Traditional tilt table
| Study group | Role | What they receive |
|---|---|---|
| Erigo® First | Other | Erigo® 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Traditional Tilt table 0 - 60 degrees
Step frequency on Erigo® = 48 Receives: Device: Erigo® Hocoma; Device: Traditional tilt table from Rehab-Care |
| Traditional first | Other | Traditional Tilt table 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Erigo® 0 - 60 degrees
Step frequency on Erigo® = 48 Receives: Device: Erigo® Hocoma; Device: Traditional tilt table from Rehab-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non Invasive Blood Pressure(NIBP)
Measured: Measured at: Baseline in supine on tilttable, 60 seconds after 30 degrees rise of tilttable, 60 seconds after 60 degrees tilt is reached. Again 60 seconds after return to 0 degrees tilt with patient still in supine position on tilttable..
Secondary outcomes (1)
Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.
Due to the included patients level of consciousness, comfort is reported as the treating therapists subjective evaluation of patients answers to standardized visual and audial question.
Measured: Question is asked within 5 minutes after 60 degrees NIBP measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter
- Responsible party
- Sponsor
- Investigators
- Jørgen F Nielsen, Prof.MD DMSc, Study director, Regionshospitalet Hammel Neurocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700399
- Sponsor's protocol ID
- SSK01
- Status last verified
- Jun 2016
- First submitted
- 5 Feb 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Study of Pulse Pressure on Respectively Tilt Table With Integrated Stepping Function (Erigo®) and Traditional Tilt Table in Adult Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02700399
- Acronym / sponsor ID
- SSK01
- Conditions
- Brain Injuries, Hypotension, Orthostatic, Syncope
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Mar 2016 (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 purpose of this study is to determine if the pulse pressure changes are different whether patients are training in a traditional tilt table as compared to a robotic assisted tilt table, which induces leg movement.
Detailed description
The trial takes place in a non private hospital in Denmark. Patients are recruited from two wards treating patients with severe brain injury, and all patients admitted in the study period are considered in regards to inclusion or exclusion. Patients are included via closest relatives accept, and the patients GP(General Practitioner). Any adverse effect or event will be reported to the local ethics committee. All data will be collected simultaneously with the interventions. Some data will be directly recorded via monitor output, and some data will be directly inputted in Epidata, while trial takes place.
Sample size has been calculated to be between 10 and 60 individuals depending on the actual difference. Beyond 60 included individuals the clinical relevance of a statistical significant result is no longer apparent. If any individual variables are noncomplete, an analysis of the subjects with missing data, will be undertaken.
The statistical analyses planned follows the general crossover design using an approach considering 2 treatment and 2 periods. Patients are cluster randomized in clusters of 4, to be treated with one or the other intervention first.
Intervention A:
Traditional tilt table. measurements at 0 degrees 30 deg. 60. deg. and at return to 0 deg.
Intervention B:
Erigo® tilttable, with measurements as in intervention A. During the intervention the step frequency of the Erigo® i set at 48 steps/min.
Between the two periods a wash out period of at least ½ hour and maximum 2 hours are planned.
Primary outcome is derived from noninvasive BP measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erigo® First | Other | Device: Erigo® Hocoma, Device: Traditional tilt table from Rehab-CareErigo® 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Traditional Tilt table 0 - 60 degrees Step frequency on Erigo® = 48 |
| Traditional first | Other | Device: Erigo® Hocoma, Device: Traditional tilt table from Rehab-CareTraditional Tilt table 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Erigo® 0 - 60 degrees Step frequency on Erigo® = 48 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Already being treated with traditional tilttable and must be able to benefit from Erigo® treatment from a clinicians view
- Acquired brain injury as primary diagnose
- Must have Rancho Los Amigo Scale score of minimum 1 to maximum 6 on the day of inclusion
Key exclusion criteria (5 listed)
- Not on mechanical ventilation
- New cerebral, cardiological or other medical problems/emergencies between the 2 interventions
- Change in cardiac medications between interventions
- Patient must not have independent gait function immediately before trial
- must not have EFA(Early Functional abilities) part score > 4 in the section "Standing", assessed by the treating physiotherapist.
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 |
|---|---|---|
| Erigo® HocomaRobotics assisted tilt table, without functional electrical stimulation | Device | Erigo® First, Traditional first |
| Traditional tilt table from Rehab-CareTraditional tilt table | Device | Erigo® First, Traditional first |
Primary outcome
Change in Non Invasive Blood Pressure(NIBP)
Time frame: Measured at: Baseline in supine on tilttable, 60 seconds after 30 degrees rise of tilttable, 60 seconds after 60 degrees tilt is reached. Again 60 seconds after return to 0 degrees tilt with patient still in supine position on tilttable..
1 secondary outcome
Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.
Time frame: Question is asked within 5 minutes after 60 degrees NIBP measurement
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 28 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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.
Jørgen F Nielsen, Prof.MD DMSc study director
Regionshospitalet Hammel Neurocenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erigo® Hocoma and Traditional tilt table from Rehab-Care in people with Brain Injuries and Hypotension, Orthostatic, run by University of Aarhus at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Change in Non Invasive Blood Pressure(NIBP) (time frame: Measured at: Baseline in supine on tilttable, 60 seconds after 30 degrees rise of tilttable, 60 seconds after 60 degrees tilt is reached. Again 60 seconds after return to 0 degrees tilt with patient still in supine position on tilttable..). 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 28 Jun 2016.