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Clinical Trials/NCT02675985
NCT02675985
Completed
Not Applicable

Effects of Early Intensive Physical Therapy for Patients With Subarachnoid Hemorrhage in a Neurological ICU

University of Colorado, Denver1 site in 1 country30 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subarachnoid Hemorrhage
Sponsor
University of Colorado, Denver
Enrollment
30
Locations
1
Primary Endpoint
Improvement in Physical function in the ICU test (PFit)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study will investigate the safety and feasibility of early intensive physical therapy for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the neurological Intensive Care Unit (ICU) and continue for 30 days or hospital discharge.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
November 14, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed by CT scan or MRI with subarachnoid hemorrhage and admitted to the neurological ICU \>48 hours.

Exclusion Criteria

  • Significant language barrier that would limit the ability to participate in the physical therapy program
  • Severe baseline physical or cognitive impairment that would impair their ability to participate in the protocol
  • Patients whose vital signs are outside the accepted starting and stopping criteria outlined below:
  • intracranial pressure ≤ 15 mm Hg
  • Cerebral perfusion pressure \>50 or \<70 mm Hg
  • Mean arterial pressure ≥ 80 and ≤ 110
  • Heart rate ≥40 and \<140 bpm
  • Pulse oximetry \>88%

Outcomes

Primary Outcomes

Improvement in Physical function in the ICU test (PFit)

Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment

Secondary Outcomes

  • Improvement in Timed up and Go (TUG)(Every 7 days until hospital discharge or 28 days of study enrollment)
  • Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility(Every 7 days until hospital discharge or 28 days of study enrollment)
  • Improvement in Postural Assessment Scale for Stroke Patients(Every 7 days until hospital discharge or 28 days of study enrollment)
  • Improvement in Medical Research Council (MRC) Muscle Sum Score(Every 7 days until hospital discharge or 28 days of study enrollment)
  • Improvement in Hand grip strength(Every 7 days until hospital discharge or 28 days of study enrollment)

Study Sites (1)

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