Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526500
Status:
UNKNOWN
Last Update Posted:
2008-11-11
First Post:
2007-09-06
Brief Title:
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 electroencephalogramand 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
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
1 Baseline measurement of electroencephalography EEG and event related potentials ERP
2 Gait training in the tilt table with integrated stepping system20 min
3 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 005 for all effect parameters
The study design is illustrated below
1 Baseline measurement of electroencephalography EEG and event related potentials ERP
2 Gait training in the tilt table with integrated stepping system20 min
3 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 005 for all effect parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None