Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury. (NCT00526500) | Clinical Trial Compass
UnknownEarly Phase 1
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
Denmark60 participantsStarted 2006-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Age over 18 years
✓. Written Consent -
Exclusion criteria
✕. Age older than 80 years
✕. Other Neurological Diseases
✕. Lack of BAEP
✕. Severe Co-morbidity
✕. Pregnancy
✕
What they're measuring
1
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
Timeframe: immediately after the end og the training
. 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)