Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Other: Physical Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Early Intensive Physical Therapy for Patients With Subarachnoid Hemorrhage in a Neurological ICU
Actual Study Start Date : August 2016
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention arm
Early intensive physical therapy will be the intervention arm. There is not a control group.
Other: Physical Therapy
Early Intensive Physical therapy in the ICU




Primary Outcome Measures :
  1. Improvement in Physical function in the ICU test (PFit) [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Improvement in Timed up and Go (TUG) [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  3. Improvement in Postural Assessment Scale for Stroke Patients [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  4. Improvement in Medical Research Council (MRC) Muscle Sum Score [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]
  5. Improvement in Hand grip strength [ Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment ]

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675985


Locations
Layout table for location information
United States, Colorado
UCH
Aurora, Colorado, United States, 80020
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Amy J Nordon-Craft University of Colorado, Denver
Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02675985    
Other Study ID Numbers: 15-0829
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Physical Therapy, early intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases