Craniocerebral TraumaEarly Phase 1NCT00526500
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
A Early Phase 1 study testing Tilt Table With Integrated Stepping System in people with Craniocerebral Trauma and Traumatic Brain Injury, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage
- What is being tested?
- Tilt Table With Integrated Stepping System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to May 2009
- Phase
- Early Phase 1
- 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
- Patient Goup:
- Severe Brain Injury
- Ongoing Impaired State of Consciousness (RLAS<4)
- Stable Vital Functions
- Written Consent from Relatives/Legal Guardian
- Control Group:
Show all 9Show fewer
- No History of Neurological Diseases in the Past
- Age over 18 years
- Written Consent -
Who cannot join
- Patient and Control Goup:
- Age older than 80 years
- Other Neurological Diseases
- Lack of BAEP
- Severe Co-morbidity
- Pregnancy
- Tilt table contraindications: orthostatic circulatory problems, unstable fractures, severe osteoporosis, sken problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (psychotic illnesses or neurotic disturbances), adjustment problems (i.e. integrated stepping system cannot be safely adjusted to the patient)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hammel Neurorehabilitation and Research Centre
Hammel, 8450
Lena Bjorn, secretary, 0045 87 62 35 62, neuleb@sc.aaa.dk
About this study
Official title: Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.
The aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials).
Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury.
- Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.
Read the detailed description
Design: Prospective controlled non-randomized study. Materials and methods: 45 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
- Baseline measurement of electroencephalography (EEG) and event related potentials (ERP)
- Gait training in the tilt table with integrated stepping system(20 min).
- Control measurement of EEG and ERP Effect parameters: se outcome measures. Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.
Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (patients vs control persons) and intra-individually factors as: 1) experimental condition (before vs after training), 2) topographic distribution (anterior vs central vs posterior).
Significance level is set to 0.05 for all effect parameters.
- Conditions
- Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury
- Being tested
- Tilt Table With Integrated Stepping System
- Keywords
- Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury, Passive Gait Training, Tilt Table With Integrated Stepping System, Electroencephalogram, Event Related Potentials
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tilt Table With Integrated Stepping SystemBehavioural
Also called P-T:patients, traumatic brain injury, P-SAH:patients, subarachnoid hemorrhage, P-A:patients, anoxi, Control: healthy volunteers
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
| Study group | Role | What they receive |
|---|---|---|
| P-T | Experimental | Not described Receives: Behavioral: Tilt Table With Integrated Stepping System |
| P- SAH | Experimental | Not described Receives: Behavioral: Tilt Table With Integrated Stepping System |
| P- A | Experimental | Not described Receives: Behavioral: Tilt Table With Integrated Stepping System |
| Control | Experimental | Not described Receives: Behavioral: Tilt Table With Integrated Stepping System |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
Measured: immediately after the end og the training
Secondary outcomes (1)
EEG: absolute and relative power in every frequency band; median frequency;
Measured: immediately after the end of the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2006
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Carsten Kock-Jensen, MD, Study director, Hammel Neurorehabilitation and Research CentreJohannes Jakobsen, MD, DMSc, Study chair, Department of Neurology, Aarhus UniversityNatallia Lapitskaya, MD, PhD-stud, Principal investigator, Hammel Neurorehabilitation and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526500
- Sponsor's protocol ID
- HNRC-AAU-07-1
- Status last verified
- Nov 2008
- First submitted
- 6 Sep 2007
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.
- ClinicalTrials.gov ID
- NCT00526500
- Acronym / sponsor ID
- HNRC-AAU-07-1
- Conditions
- Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury
- Keywords
- Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury, Passive Gait Training, Tilt Table With Integrated Stepping System, Electroencephalogram, Event Related Potentials
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 10 Sep 2007 (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 is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials).
Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury.
- Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.
Detailed description
Design: Prospective controlled non-randomized study. Materials and methods: 45 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
- Baseline measurement of electroencephalography (EEG) and event related potentials (ERP)
- Gait training in the tilt table with integrated stepping system(20 min).
- Control measurement of EEG and ERP Effect parameters: se outcome measures. Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.
Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (patients vs control persons) and intra-individually factors as: 1) experimental condition (before vs after training), 2) topographic distribution (anterior vs central vs posterior).
Significance level is set to 0.05 for all effect parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P-T | Experimental | Behavioral: Tilt Table With Integrated Stepping System |
| P- SAH | Experimental | Behavioral: Tilt Table With Integrated Stepping System |
| P- A | Experimental | Behavioral: Tilt Table With Integrated Stepping System |
| Control | Experimental | Behavioral: Tilt Table With Integrated Stepping System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Severe Brain Injury
- Ongoing Impaired State of Consciousness (RLAS<4)
- Stable Vital Functions
- Written Consent from Relatives/Legal Guardian
- No History of Neurological Diseases in the Past
Key exclusion criteria (7 listed)
- Age older than 80 years
- Other Neurological Diseases
- Lack of BAEP
- Severe Co-morbidity
- Pregnancy
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 |
|---|---|---|
| Tilt Table With Integrated Stepping SystemAlso: P-T:patients, traumatic brain injury, P-SAH:patients, subarachnoid hemorrhage, P-A:patients, anoxi, Control: healthy volunteersPassive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute. | Behavioural | Control, P- A, P- SAH, P-T |
Primary outcome
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
Time frame: immediately after the end og the training
1 secondary outcome
EEG: absolute and relative power in every frequency band; median frequency;
Time frame: immediately after the end of the training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2008.
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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.
Carsten Kock-Jensen, MD study director
Hammel Neurorehabilitation and Research Centre
Johannes Jakobsen, MD, DMSc study chair
Department of Neurology, Aarhus University
Natallia Lapitskaya, MD, PhD-stud principal investigator
Hammel Neurorehabilitation and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tilt Table With Integrated Stepping System in people with Craniocerebral Trauma and Traumatic Brain Injury, 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Nov 2008. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natallia Lapitskaya, MD, PhD-stud (004587623573, neunla@sc.aaa.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component. (time frame: immediately after the end og the training). 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 11 Nov 2008.