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

This study has been completed.
Sponsor:
Collaborator:
Aarhus County, Denmark
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00430703
First received: February 1, 2007
Last updated: November 5, 2008
Last verified: November 2008
History of Changes
  Purpose

The aim of this study is to determine whether passive gait training increases arousal, demonstrated as changes in EEG (electroencephalogram) activity.

Hypotheses: 1) Passive gait training increases EEG-frequency in patients with impaired consciousness due to severe traumatic brain injury.

2) Passive gait training increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe traumatic brain injury.


Condition Intervention Phase
Craniocerebral Trauma
Traumatic Brain Injury
"Rehabilitation"
 Behavioral: body weight support treadmill training
 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 Massive Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired States of Consciousness After Severe Traumatic Brain Injury.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • EEG: difference in the frequency spectrum after training. [ Time Frame: 0-30 minutes after training end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EEG: absolute power i every frequency band; median frequency; [ Time Frame: 0-30 minutes after training end ] [ Designated as safety issue: No ]
  • frequency ratios: Alpha versus delta;delta and theta versus alpha and beta; [ Time Frame: 0-30 minutes after training end ] [ Designated as safety issue: No ]
  • ERP: amplitude of P300-component. [ Time Frame: 30-60 minutes after training end ] [ Designated as safety issue: No ]
  • ERP: latency of P300-component. [ Time Frame: 30-60 minutes after training ] [ Designated as safety issue: No ]
  • clinical measure: RLAS (Rancho Los Amigos Scale) [ Time Frame: discharge from the rehabilitation unit ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with severe traumatic brain injury
 Behavioral: body weight support treadmill training
Gait training: Gait robot (Lokomat®, Hocoma, Switzerland) is adjusted to the patient/healthy volunteer individually with chest strap, pelvic straps, harness, leg cuffs and foot lifters. Weight is adjusted individually, so there is a minimum weight support (i.e. when one foot is standing on the treadmill the other foot lifts free from the treadmill thereby simulating normal gait). Gait speed is 1,7-2,3 km/hour (speed can be changed and adjusted that the normal step length is achieved).The duration of the training session is 20 minutes.Blood pressure and pulse are monitored.
Other Name: Body Weight Support Treadmill Training
Experimental: 2
Healthy volunteers
 Behavioral: body weight support treadmill training
Gait training: Gait robot (Lokomat®, Hocoma, Switzerland) is adjusted to the patient/healthy volunteer individually with chest strap, pelvic straps, harness, leg cuffs and foot lifters. Weight is adjusted individually, so there is a minimum weight support (i.e. when one foot is standing on the treadmill the other foot lifts free from the treadmill thereby simulating normal gait). Gait speed is 1,7-2,3 km/hour (speed can be changed and adjusted that the normal step length is achieved).The duration of the training session is 20 minutes.Blood pressure and pulse are monitored.
Other Name: Body Weight Support Treadmill Training

Detailed Description:

Severe traumatic brain injury, especially after a high energy trauma, is characterised with focal lesions and diffuse axonal injury, which leads to the dysfunction in the cortico-spinal, cortico- cortical connections and reticular activation system. Formatio reticularis plays an important role in arousal. Tactile and proprioceptive stimulation with a view to improving level of consciousness in coma patients is popular in the western world despite insufficient evidence of its effectiveness. Affolter-Bobath-Coombes-concept is the most commonly used tool in the rehabilitation of brain damaged patients. This concept is based on the theory that tactile, proprioceptive and oral stimulation develops new connections in the brain and thereby stimulates consciousness and behaviour. Elliot et al shows improvement in level of consciousness due to postural changes from a lying position to a standing posture in 8 of 12 patients using Wessex Head Injury Matrix.

Passive movements result in proprioceptive stimulation; the effect of which is close to that achieved by physiological voluntary activity. PET and fMRI studies show that passive movements activate several areas in the motor cortex.

In order to increase afferent cortical input, passive gait training in the body weight support robotic gait orthosis could be used in patients with impaired consciousness, inability to cooperate and poor balance. This device gives the possibility to establish therapeutically correct upright body position and passive legs movement simultaneously.

To our knowledge there are no studies, which illustrate the effects of passive gait training on cortical activity in patients with impaired consciousness due to severe traumatic brain injury.

Our hypothesis is that passive gait training of this group of patients increases arousal, which can be shown in an increased EEG (electroencephalogram)-frequency and increased conductivity speed of the cognitive P300-component of ERP (Event Related Potentials).

Comparison(s): EEG- and ERP-activity after a single training session in robotic gait orthosis in patients with severe traumatic brain injury, compared to EEG- and ERP-activity after a single training session in robotic gait orthosis in healthy persons.

  Eligibility

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

Inclusion Criteria:

Patient group :

  1. severe brain injury (GCS-scale< 8 on admission to the hospital);
  2. Ongoing impaired state of consciousness (RLAS-scale≤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 agreement.

Exclusion Criteria:

Patient and control group:

  1. age older than 80 years;
  2. other neurological disease;
  3. lack of BAEP and SEP;
  4. severe co-morbidity;
  5. pregnancy;
  6. robotic orthosis contraindications (orthostatic circulatory problems, unstable fractures, severe osteoporosis, skin problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (reduced cooperation, psychotic illnesses or neurotic disturbances), body weight over 100 kg, adjustment problems (i.e. robot cannot be safely adjusted to the patient).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430703

Locations
Denmark
Hammel Neurorehabilitation and Research Centre
Hammel, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
Aarhus County, Denmark
Investigators
Study Director: Karsten Koch-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: NCT00430703     History of Changes
Other Study ID Numbers: HNRC-AAU-06-1
Study First Received: February 1, 2007
Last Updated: November 5, 2008
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by University of Aarhus:
severe traumatic brain injury
body weight support treadmill training
Electroencephalogram
Event Related Potentials

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Trauma, Nervous System
Nervous System Diseases
 Wounds and Injuries
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013