Clinical trial NCT02098083: Evaluation of Physical Therapy Interventions and Patient Characteristics on Outcomes
Official title: Evaluation of Physical Therapy Interventions and Patient Characteristics on Functional Mobility Outcomes in Persons With Acute Stroke
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Stroke
Keywords: acute
stroke
gait
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons post stroke admitted to inpatient rehabilitation units

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-Minute Walk Test
timeFrame: Subjects will be followed for the duration of inpatient rehabilitation, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Institute for Rehabilitation
state: Texas
city: Frisco
country: United States
facility: Baylor Institute for Rehabilitation Frisco
state: Texas
city: Ft. Worth
country: United States
facility: Baylor All Saints
state: Texas
city: Irving
country: United States
facility: Baylor Medical Center of Irving
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Karen J McCain, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
References: