ICU patients with neurological disorders
Conditions
Interventions
Early Rehabilitation Intervention Group:Multimodal monitoring-guided personalized early rehabilitation protocol: Based on standardized early rehabilitation training (2 sessions per day of passive join
1 session per day of sitting balance training, 10 minutes), continuous multimodal neural monitoring (fNIRS, TCD, EEG) is performed throughout. Rehabilitation intensity, progression, or suspension is d
Control Group:Standard fixed rehabilitation protocol: Participants receive the same standardized early rehabilitation training as in the experimental group (2 sessions per day of passive joint movemen
1 session per day of sitting balance training, 10 minutes). However, multimodal monitoring devices are used solely for data collection during rehabilitation and real-time monitoring parameters are not
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years old and have signed a written informed consent form. If the patient is unable to sign due to consciousness disorders, it must be signed by their legally authorized representative (LAR); In case of emergency, if it is not possible to obtain immediate consent from the representative, the study can be included in accordance with relevant regulatory provisions and delayed consent from the patient or representative can be obtained as soon as possible. 2. There are clear acute neurological disorders (such as severe traumatic brain injury, extensive cerebral infarction, subarachnoid hemorrhage, hypoxic-ischemic encephalopathy, etc.), which have been confirmed by neuroimaging (CT/MRI) or clinical neurological function assessment. 3. State of consciousness disorder: (1) Glasgow Coma Scale (GCS) score = 65 mmHg), and have transitioned from the acute phase to the early rehabilitation phase (within 24 hours to 7 days after admission to the ICU). (2) There are no absolute contraindications for early recovery (such as untreated stable fractures, active bleeding, untreated deep vein thrombosis, etc.). 5. The time interval between self admission to the ICU and planned randomization is less than 7 days. 6. The skull structure is intact, without bilateral temporal window loss, and meets the basic anatomical conditions for transcranial Doppler ultrasound (TCD) and near-infrared spectroscopy (NIRS) monitoring.
Exclusion criteria
Exclusion criteria: 1. Any physiological or anatomical factors that may seriously affect the quality or interpretation of multimodal monitoring signals (such as large skull defects, skull repair surgery, severe scalp hematoma, or subcutaneous emphysema) will not be included in the study. 2. During this ICU stay, the diagnosis was confirmed to be brain death or met the criteria for irreversible brain injury. 3. The risk of death during this hospitalization is extremely high, and the attending physician, patient, or alternative decision maker does not promise to take active treatment. 4. Due to end-stage underlying diseases such as advanced malignant tumors, end-stage heart failure, etc., life expectancy is extremely short (possibly less than 1 month). 5. A decision has been made to restrict or revoke active treatment, excluding early rehabilitation interventions. 6. Known to be pregnant or breastfeeding. 7. There are any other conditions that researchers believe may interfere with research evaluation or pose additional risks to patient participation in the study (such as a history of severe dementia, long-term mental illness, drug addiction, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R) scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery of background EEG rhythm (dominant frequency, slow wave index) and sensory-motor cortex activation pattern assessed by functional near-infrared spectroscopy (fNIRS) (magnitude and temporal profile of oxyhemoglobin concentration changes);Long-term neurological outcomes (GOS-E score, modified Rankin Scale score); | — |
Countries
China
Contacts
Public ContactLi Lianchi
West China Hospital of Sichuan University
Outcome results
None listed