Evaluation of Physical Therapy Interventions and Patient Characteristics on Outcomes

Acute Stroke Clinical Trial

— PBE  

Official title:

Evaluation of Physical Therapy Interventions and Patient Characteristics on Functional Mobility Outcomes in Persons With Acute Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02098083
• Other study ID #: STU 092013-009
• Status: Withdrawn
• Phase: N/A
• First received: March 20, 2014
• Last updated: July 29, 2015
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Data collection for this study will be done by clinicians working in inpatient rehabilitation units with persons with acute stroke. No interventions are included in this study. It is designed to capture trends in current clinical practice for persons with stroke. This data will be useful in identifying the most beneficial and effective walking treatments as well as most significant patient characteristics that impact recovery for persons acutely after stroke. All data collection will take place during the inpatient rehabilitation stay.

Description:

All persons admitted to the inpatient rehabilitation unit will be screened for inclusion. Only those with a confirmed diagnosis of stroke (CVA) will be included. Data collection on the participants will begin at the time of admission and continue through discharge. Average length of stay for persons with stroke in inpatient rehabilitation units is 21 days. Some persons will stay fewer days and some will stay longer. Data collection will include key information on physical therapy interventions including gait training, balance training, group therapy, manual therapy, exercise, transfer training, stairs, family training, wheelchair training, modalities, discharge planning, seated and supine exercises. Other data will be collected including tone, motor control, sensation, gait endurance, falls, wounds, restraints, deep vein thrombosis, tracheostomy, feeding tubes and blood pressure. Additional data collection will include age, gender, race, length of time post stroke, time in rehabilitation, Functional Independence Measure scores, case mix group, discharge destination. In addition, physician history and physical as well as discharge summary will be collected, as will evaluation and discharge notes from therapies (physical, occupation, speech, social work). Patients will not be responsible for any costs associated with this data collection.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any patient with a confirmed primary diagnosis of stroke, within 6 weeks of onset, will be included.

• Persons will be between the ages of 16 and 80.

• Persons may have experienced a previous CVA if they experienced a full gait recovery.

Exclusion Criteria:

• Any patient with a history of stroke onset greater than 6 weeks prior to admission will not be included.

• In addition, persons with bilateral CVA will not be included as well as persons who were not ambulatory prior to the CVA.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke

Locations

Country	Name	City	State
United States	Baylor Institute for Rehabilitation	Dallas	Texas
United States	Baylor Institute for Rehabilitation Frisco	Frisco	Texas
United States	Baylor All Saints	Ft. Worth	Texas
United States	Baylor Medical Center of Irving	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Minute Walk Test	The 6-Minute Walk Test is a test of walking endurance that is valid and reliable for persons post stroke.	Subjects will be followed for the duration of inpatient rehabilitation, an expected average of 4 weeks	No