Early Intensive Physical Therapy in Subarachnoid Hemorrhage

Not Applicable

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Other: Physical Therapy

• Registration Number: NCT02675985
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Study Start: 2016-08
• Primary Completion: 2017-11-14
• Study Completion: 2017-11-14
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Physical Therapy	Early intensive physical therapy will be the intervention arm. There is not a control group.

Primary Outcome Measures

Name	Time	Method
Improvement in Physical function in the ICU test (PFit)	Every 7 days until hospital discharge or 28 days of study enrollment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UCH; 🇺🇸 Aurora, Colorado, United States