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

Traumatic Brain Injury Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430703
• Other study ID #: HNRC-AAU-06-1
• Status: Completed
• Phase: Phase 0
• First received: February 1, 2007
• Last updated: November 5, 2008
• Start date: August 2006
• Est. completion date: August 2008

Study information

• Verified date: November 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Craniocerebral Trauma
• Rehabilitation
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation and Research Centre	Hammel

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus County, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG: difference in the frequency spectrum after training.		0-30 minutes after training end	No
Secondary	EEG: absolute power i every frequency band; median frequency;		0-30 minutes after training end	No
Secondary	frequency ratios: Alpha versus delta;delta and theta versus alpha and beta;		0-30 minutes after training end	No
Secondary	ERP: amplitude of P300-component.		30-60 minutes after training end	No
Secondary	ERP: latency of P300-component.		30-60 minutes after training	No
Secondary	clinical measure: RLAS (Rancho Los Amigos Scale)		discharge from the rehabilitation unit	No