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Clinical Trials/ISRCTN12562519
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.

Registry
who.int
Start Date
September 19, 2013
End Date
April 1, 2014
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Birmingham (UK)

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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