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Completed

NCT Number: NCT02675985

Early Intensive Physical Therapy in Subarachnoid Hemorrhage

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCH

Aurora, Colorado, 80020, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Physical Therapy

Other

Early Intensive Physical therapy in the ICU

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2016
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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