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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.
2) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-T | Experimental |
| |
| P- SAH | Experimental |
| |
| P- A | Experimental |
| |
| Control | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilt Table With Integrated Stepping System | Behavioral | Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component. | immediately after the end og the training |
| Measure | Description | Time Frame |
|---|---|---|
| EEG: absolute and relative power in every frequency band; median frequency; | immediately after the end of the training |
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Inclusion Criteria:
Patient Goup:
Control Group:
Exclusion Criteria:
Patient and Control Goup:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natallia Lapitskaya, MD, PhD-stud | Contact | 004587623573 | neunla@sc.aaa.dk | |
| Lena Bjorn, secretary | Contact | 0045 8762 3562 | neuleb@sc.aaa.dk |
| Name | Affiliation | Role |
|---|---|---|
| Carsten Kock-Jensen, MD | Hammel Neurorehabilitation and Research Centre | Study Director |
| Johannes Jakobsen, MD, DMSc | Department of Neurology, Aarhus University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammel Neurorehabilitation and Research Centre | Recruiting | Hammel | 8450 | Denmark |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
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|
| Natallia Lapitskaya, MD, PhD-stud |
| Hammel Neurorehabilitation and Research Centre |
| Principal Investigator |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002545 | Brain Ischemia |
| D002534 | Hypoxia, Brain |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |