ISRCTN12562519
Completed
Phase 2
A pilot randomised controlled trial of electrical and magnetic stimulation against sham to mitigate intensive-care-unit-acquired weakness after trauma
niversity of Birmingham (UK)0 sites30 target enrollmentSeptember 19, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ICU-acquired weakness
- Sponsor
- niversity of Birmingham (UK)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must:
- •1\. be aged 16 years old or over
- •2\. have been able to transfer independently from bed to chair prior to injury
- •3\. be admitted to the Critical Care Unit at Queen Elizabeth Hospital, Birmingham as result of traumatic injury
- •4\. have an anticipated length of stay of at least 2 weeks
- •5\. give consent (or, if lacking capacity at screening, have a personal or professional consultee indicate that they would be likely to give consent were they not lacking capacity)
- •Target Gender: Male \& Female
Exclusion Criteria
- •Patients must not:
- •1\. refuse to allow their GP to be informed of participation
- •2\. have known systemic neuromuscular disease (e.g. Guillain Barré Syndrome) at ICU admission
- •3\. have known pathology affecting the brain, causing weakness (e.g. stroke or bleeding in the brain) at the time of Critical Care Unit admission
- •4\. have any pacemaker (e.g., cardiac, diaphragm, gastric) or implanted cardiac defibrillator, neurostimulator, intracardiac line or cochlear implant
- •5\. have any metallic implants or foreign bodies in the areas to be stimulated
- •6\. have any metal (other than titanium) in the head or brain
- •7\. have known or suspected malignancy in any limb
- •8\. be pregnant
- •9\. have a body mass index \=35 kg/m2
Outcomes
Primary Outcomes
Not specified
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