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

This study is currently recruiting participants.
Verified by University of Aarhus, March 2008

Sponsors and Collaborators: University of Aarhus
County of Aarhus
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00430703
  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

MedlinePlus related topics:   Head and Brain Injuries    Injuries    Wounds   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • EEG: 1)difference in the frequency spectrum after training. [ Time Frame: 0-30 minutes after training end ] [ Designated as safety issue: No ]
  • ERP: 1)latency of P300-component. [ Time Frame: 30-60 minutes after training end ] [ Designated as safety issue: No ]
  • clinical measure: RLAS (Rancho Los Amigos Scale) [ Time Frame: discharge from the rehabilitation unit ] [ 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 ]

Estimated Enrollment:   20
Study Start Date:   August 2006
Estimated Study Completion Date:   March 2008
Estimated Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    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.
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

Contacts
Contact: Natallia Lapitskaya, MD, PhD-stud     004587623573     neunla@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
County of Aarhus

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

Responsible Party:   Hammel Neurorehabilitation and Research Centre ( Natallia Lapitskaya, MD )
Study ID Numbers:   HNRC-AAU-06-1
First Received:   February 1, 2007
Last Updated:   March 26, 2008
ClinicalTrials.gov Identifier:   NCT00430703
Health Authority:   Denmark: The Ministry of the Interior and Health

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

Study placed in the following topic categories:
Body Weight
Craniocerebral Trauma
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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