Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.

Study Overview
=================
Brief 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). 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.

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.

Official Title
-----------------
Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.

Conditions
-----------------
Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: Tilt Table With Integrated Stepping System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Goup: Severe Brain Injury Ongoing Impaired State of Consciousness (RLAS<4) Stable Vital Functions Written Consent from Relatives/Legal Guardian Control Group: No History of Neurological Diseases in the Past Age over 18 years Written Consent - Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-T<br> | Behavioral: Tilt Table With Integrated Stepping System<br>* Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.<br>* Other names: Control: healthy volunteers;|
| Experimental: P- SAH<br> | Behavioral: Tilt Table With Integrated Stepping System<br>* Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.<br>* Other names: Control: healthy volunteers;|
| Experimental: P- A<br> | Behavioral: Tilt Table With Integrated Stepping System<br>* Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.<br>* Other names: Control: healthy volunteers;|
| Experimental: Control<br> | Behavioral: Tilt Table With Integrated Stepping System<br>* Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.<br>* Other names: Control: healthy volunteers;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG: absolute and relative power in every frequency band; median frequency; |  | immediately after the end of the training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anoxic Brain Injury, Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Passive Gait Training, Tilt Table With Integrated Stepping System, Electroencephalogram, Event Related Potentials