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Sympathetic effects of early mobilization in patients with severe brain injuries

Sympathetic activity and early mobilization in patients in intensive and intermediate care with severe brain injuries: a preliminary prospective randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56402432
Enrollment
30
Registered
2016-03-08
Start date
2012-07-27
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain injury Nervous System Diseases Brain injury

Interventions

Participants are randomized into 3 groups with different protocols of mobilization. Group 1: Participants are mobilized out of bed by physiotherapists, according to usual clinical physiotherapy stand

Sponsors

Hocoma AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Severe neurological injury - traumatic and non- traumatic injuries, requiring neurological, cardiovascular and respiratory functions monitoring 24/7 at the moment of the admission (for example subarachnoid hemorrhage, severe brain trauma, intra-parenchymal hemorrhage, ischemic vascular accident, brain anoxia) 3. Bed rest for at least 7 days 4. Continuous monitoring in the Intermediate Care Unit 5. Signed informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria for Group 1: Not meeting the inclusion criteria. Exclusion criteria for Group 2: 1. Amputation of a leg, with impossibility to pedal 2. Trauma or previous surgery of the feet, pelvis or lumbar column 3. Abdominal open wound 4. Extreme obesity (BMI> 35) 5. Ulcers 6. Height 135 kg 3. Leg length 102 cm 4. Bone instability 5. Open ulcers or vascular disease of the legs 6. Cardiac contro-indications 7. Inadequate cooperation of the patient

Design outcomes

Primary

MeasureTime frame
Sympathetic activity is measured by detecting catecholamine (Epinephrine and Norepinephrine) and plasma free metanephrine (Metanephrine, Normetanephrine and Methoxytyramine) concentrations immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again.

Secondary

MeasureTime frame
1. Blood pressure is measured using a sphygmomanometer upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again 2. Heart rate is measured using a heart rate montior upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again 3. Respiratory rate is measured using an optical breath rate sensor upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again 4. Cerebral blood flow velocity is measured using a transcranial Doppler (for patients with subarachnoid hemorrhage only) upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed and one hour after lying in bed again

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026