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Early Intensive Physical Therapy in Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675985
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 2, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date June 28, 2021
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
Improvement in Physical function in the ICU test (PFit) [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  • Improvement in Timed up and Go (TUG) [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  • Improvement in Postural Assessment Scale for Stroke Patients [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  • Improvement in Medical Research Council (MRC) Muscle Sum Score [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  • Improvement in Hand grip strength [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2016)
Neuro-Quality of Life (QOL) [ Time Frame: Hospital Discharge only ]
Neuro-QOL measures 17 domains of health related quality of life for adults through self-report.. We will use the short form versions for applied cognition, lower extremity mobility and Upper extremity function and Satisfaction with social roles/activities.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Early Intensive Physical Therapy in Subarachnoid Hemorrhage
Official Title  ICMJE Effects of Early Intensive Physical Therapy for Patients With Subarachnoid Hemorrhage in a Neurological ICU
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Subarachnoid Hemorrhage
Intervention  ICMJE Other: Physical Therapy
Early Intensive Physical therapy in the ICU
Study Arms  ICMJE Experimental: Intervention arm
Early intensive physical therapy will be the intervention arm. There is not a control group.
Intervention: Other: Physical Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
40
Actual Study Completion Date  ICMJE November 14, 2017
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. intracranial pressure ≤ 15 mm Hg
    2. Cerebral perfusion pressure >50 or <70 mm Hg
    3. Mean arterial pressure ≥ 80 and ≤ 110
    4. Heart rate ≥40 and <140 bpm
    5. Pulse oximetry >88%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675985
Other Study ID Numbers  ICMJE 15-0829
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy J Nordon-Craft University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP