Early Intensive Physical Therapy in Subarachnoid Hemorrhage

June 25, 2021 updated by: University of Colorado, Denver

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

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 Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80020
        • UCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Physical function in the ICU test (PFit)
Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment
Every 7 days until hospital discharge or 28 days of study enrollment

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hospital Discharge only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amy J Nordon-Craft, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

November 14, 2017

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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