Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT00430703
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-scaleā¤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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00430703
Study Brief:
Protocol Section:
NCT00430703