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Clinical Trials/NCT02675985
NCT02675985CompletedNot Applicable

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

University of Colorado, Denver2 sites in 1 country30 target enrollmentStarted: August 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Improvement in Physical function in the ICU test (PFit)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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