Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
Primary Purpose
Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage
Status
Unknown status
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Tilt Table With Integrated Stepping System
Sponsored by
About this trial
This is an interventional treatment trial for Craniocerebral Trauma focused on measuring Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury, Passive Gait Training, Tilt Table With Integrated Stepping System, Electroencephalogram, Event Related Potentials
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)
Sites / Locations
- Hammel Neurorehabilitation and Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
P-T
P- SAH
P- A
Control
Arm Description
Outcomes
Primary Outcome Measures
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
Secondary Outcome Measures
EEG: absolute and relative power in every frequency band; median frequency;
Full Information
NCT ID
NCT00526500
First Posted
September 6, 2007
Last Updated
November 10, 2008
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00526500
Brief Title
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
Official Title
Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury
Keywords
Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury, Passive Gait Training, Tilt Table With Integrated Stepping System, Electroencephalogram, Event Related Potentials
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
P-T
Arm Type
Experimental
Arm Title
P- SAH
Arm Type
Experimental
Arm Title
P- A
Arm Type
Experimental
Arm Title
Control
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Tilt Table With Integrated Stepping System
Other Intervention Name(s)
P-T:patients, traumatic brain injury, P-SAH:patients, subarachnoid hemorrhage, P-A:patients, anoxi, Control: healthy volunteers
Intervention Description
Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
Primary Outcome Measure Information:
Title
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
Time Frame
immediately after the end og the training
Secondary Outcome Measure Information:
Title
EEG: absolute and relative power in every frequency band; median frequency;
Time Frame
immediately after the end of the training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natallia Lapitskaya, MD, PhD-stud
Phone
004587623573
Email
neunla@sc.aaa.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Bjorn, secretary
Phone
0045 8762 3562
Email
neuleb@sc.aaa.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten Kock-Jensen, MD
Organizational Affiliation
Hammel Neurorehabilitation and Research Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johannes Jakobsen, MD, DMSc
Organizational Affiliation
Department of Neurology, Aarhus University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Natallia Lapitskaya, MD, PhD-stud
Organizational Affiliation
Hammel Neurorehabilitation and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation and Research Centre
City
Hammel
ZIP/Postal Code
8450
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Bjorn, secretary
Phone
0045 87 62 35 62
Email
neuleb@sc.aaa.dk
12. IPD Sharing Statement
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Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
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