Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
NCT ID: NCT00526500
Last Updated: 2008-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2006-08-31
2009-05-31
Brief Summary
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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
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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 system(20 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 0.05 for all effect parameters.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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P-T
Tilt Table With Integrated Stepping System
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
P- SAH
Tilt Table With Integrated Stepping System
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
P- A
Tilt Table With Integrated Stepping System
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
Control
Tilt Table With Integrated Stepping System
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
Interventions
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Tilt Table With Integrated Stepping System
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Hammel Neurorehabilitation and Research Centre
Principal Investigators
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Carsten Kock-Jensen, MD
Role: STUDY_DIRECTOR
Hammel Neurorehabilitation and Research Centre
Johannes Jakobsen, MD, DMSc
Role: STUDY_CHAIR
Department of Neurology, Aarhus University
Natallia Lapitskaya, MD, PhD-stud
Role: PRINCIPAL_INVESTIGATOR
Hammel Neurorehabilitation and Research Centre
Locations
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Hammel Neurorehabilitation and Research Centre
Hammel, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Lena Bjorn, secretary
Role: primary
Other Identifiers
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HNRC-AAU-07-1
Identifier Type: -
Identifier Source: org_study_id