Clinical trial NCT00430703: Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Traumatic Brain Injury.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Craniocerebral Trauma
Traumatic Brain Injury
"Rehabilitation"
Keywords: severe traumatic brain injury
body weight support treadmill training
Electroencephalogram
Event Related Potentials
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus County, Denmark
First posted: 2007-02-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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).

Primary outcomes:
measure: EEG: difference in the frequency spectrum after training.
timeFrame: 0-30 minutes after training end
Secondary outcomes:
measure: EEG: absolute power i every frequency band; median frequency;
timeFrame: 0-30 minutes after training end
measure: frequency ratios: Alpha versus delta;delta and theta versus alpha and beta;
timeFrame: 0-30 minutes after training end
measure: ERP: amplitude of P300-component.
timeFrame: 30-60 minutes after training end
measure: ERP: latency of P300-component.
timeFrame: 30-60 minutes after training
measure: clinical measure: RLAS (Rancho Los Amigos Scale)
timeFrame: discharge from the rehabilitation unit
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation and Research Centre
Study officials:
affiliation: Hammel Neurorehabilitation and Research Centre
name: Karsten Koch-Jensen, MD
role: STUDY_DIRECTOR
affiliation: Department of Neurology, Aarhus University
name: Johannes Jakobsen, MD, DMSc
role: STUDY_CHAIR
affiliation: Hammel Neurorehabilitation and Research Centre
name: Natallia Lapitskaya, MD, PhD-stud
role: PRINCIPAL_INVESTIGATOR
References: