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

November 10, 2008 updated by: University of Aarhus

Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Recruiting
        • Hammel Neurorehabilitation and Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
immediately after the end og the training

Secondary Outcome Measures

Outcome Measure
Time Frame
EEG: absolute and relative power in every frequency band; median frequency;
Time Frame: immediately after the end of the training
immediately after the end of the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Johannes Jakobsen, MD, DMSc, Department of Neurology, Aarhus University
  • Principal Investigator: Natallia Lapitskaya, MD, PhD-stud, Hammel Neurorehabilitation and Research Centre
  • Study Director: Carsten Kock-Jensen, MD, Hammel Neurorehabilitation and Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

November 11, 2008

Last Update Submitted That Met QC Criteria

November 10, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNRC-AAU-07-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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