Status:
COMPLETED
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Traumatic Brain Injury.
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus County, Denmark
Conditions:
Craniocerebral Trauma
Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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 E...
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- cort...
Eligibility Criteria
Inclusion
- Patient group :
- severe brain injury (GCS-scale\< 8 on admission to the hospital);
- Ongoing impaired state of consciousness (RLAS-scale≤4);
- stable vital functions;
- written consent from relatives/ legal guardian.
- Control group:
- no history of neurological diseases in the past;
- age over 18 years;
- written agreement.
Exclusion
- Patient and control group:
- age older than 80 years;
- other neurological disease;
- lack of BAEP and SEP;
- severe co-morbidity;
- pregnancy;
- 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).
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00430703
Start Date
August 1 2006
End Date
August 1 2008
Last Update
November 6 2008
Active Locations (1)
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1
Hammel Neurorehabilitation and Research Centre
Hammel, Denmark, 8450