Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Traumatic Brain Injury.
Condition: Craniocerebral Trauma; Traumatic Brain Injury; "Rehabilitation"
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

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.
    

Intervention name(s): body weight support treadmill training
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe traumatic brain injury; body weight support treadmill training; Electroencephalogram; Event Related Potentials