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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00526500
First received: September 6, 2007
Last updated: November 10, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Craniocerebral Trauma
Traumatic Brain Injury
Subarachnoid Hemorrhage
Anoxic Brain Injury
 Behavioral: Tilt Table With Integrated Stepping System
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EEG: absolute and relative power in every frequency band; median frequency; [ Time Frame: immediately after the end of the training ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P-T Behavioral: 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 Names:
  • P-T:patients, traumatic brain injury
  • P-SAH:patients, subarachnoid hemorrhage
  • P-A:patients, anoxi
  • Control: healthy volunteers
Experimental: P- SAH Behavioral: 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 Names:
  • P-T:patients, traumatic brain injury
  • P-SAH:patients, subarachnoid hemorrhage
  • P-A:patients, anoxi
  • Control: healthy volunteers
Experimental: P- A Behavioral: 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 Names:
  • P-T:patients, traumatic brain injury
  • P-SAH:patients, subarachnoid hemorrhage
  • P-A:patients, anoxi
  • Control: healthy volunteers
Experimental: Control Behavioral: 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 Names:
  • P-T:patients, traumatic brain injury
  • P-SAH:patients, subarachnoid hemorrhage
  • P-A:patients, anoxi
  • Control: healthy volunteers

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526500

Contacts
Contact: Natallia Lapitskaya, MD, PhD-stud 004587623573 neunla@sc.aaa.dk
Contact: Lena Bjorn, secretary 0045 8762 3562 neuleb@sc.aaa.dk

Locations
Denmark
Hammel Neurorehabilitation and Research Centre Recruiting
Hammel, Denmark, 8450
Contact: Lena Bjorn, secretary     0045 87 62 35 62     neuleb@sc.aaa.dk    
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Carsten Kock-Jensen, MD Hammel Neurorehabilitation and Research Centre
Study Chair: Johannes Jakobsen, MD, DMSc Department of Neurology, Aarhus University
Principal Investigator: Natallia Lapitskaya, MD, PhD-stud Hammel Neurorehabilitation and Research Centre
  More Information

No publications provided

Responsible Party: Natallia Lapitskaya, MD, Hammel Neurorehabilitation and Research Centre
ClinicalTrials.gov Identifier: NCT00526500     History of Changes
Other Study ID Numbers: HNRC-AAU-07-1
Study First Received: September 6, 2007
Last Updated: November 10, 2008
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by University of Aarhus:
Severe Traumatic Brain Injury
Subarachnoid Hemorrhage
Anoxic Brain Injury
Passive Gait Training
 Tilt Table With Integrated Stepping System
Electroencephalogram
Event Related Potentials

Additional relevant MeSH terms:
Hypoxia, Brain
Craniocerebral Trauma
Hemorrhage
Subarachnoid Hemorrhage
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013