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

Craniocerebral Trauma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: Patient Goup: 1. Severe Brain Injury 2. Ongoing Impaired State of Consciousness (RLAS<4) 3. Stable Vital Functions 4. Written Consent from Relatives/Legal Guardian Control Group: 1. No History of Neurological Diseases in the Past 2. Age over 18 years 3. Written Consent - Exclusion Criteria: Patient and Control Goup: 1. Age older than 80 years 2. Other Neurological Diseases 3. Lack of BAEP 4. Severe Co-morbidity 5. Pregnancy 6. 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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Craniocerebral Trauma

Traumatic Brain Injury

Subarachnoid Hemorrhage

Anoxic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Tilt Table With Integrated Stepping SystemPassive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

P-T

P- SAH

P- A

Control

Study Status

Unknown status

Start Date: August 2006

Completed Date: May 2009

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.

Secondary Outcome: EEG: absolute and relative power in every frequency band; median frequency;

Study sponsors, principal investigator, and references

Principal Investigator: Carsten Kock-Jensen, MD

Lead Sponsor: University of Aarhus

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00526500

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