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WithdrawnNCT02098083PBEUpdated Jul 31, 2015

Evaluation of Physical Therapy Interventions and Patient Characteristics on Outcomes

An observational study in Acute Stroke, sponsored by University of Texas Southwestern Medical Center. Withdrawn at 4 sites in United States. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by University of Texas Southwestern Medical Center · Observational

Why this study was withdrawn
Unable to collect data
Study type
Observational
Time perspective
Prospective
Enrollment
0
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Stroke

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Keywords

  • acute
  • stroke
  • gait
03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

Browse Stroke studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Persons post stroke admitted to inpatient rehabilitation units

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

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.
05

Study design

Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 6-Minute Walk Test

    The 6-Minute Walk Test is a test of walking endurance that is valid and reliable for persons post stroke.

    Time frame: Subjects will be followed for the duration of inpatient rehabilitation, an expected average of 4 weeks

07

Study locations

4 sites
  • Baylor Institute for Rehabilitation
    Dallas, Texas 75246, United States
  • Baylor Institute for Rehabilitation Frisco
    Frisco, Texas 75034, United States
  • Baylor All Saints
    Ft. Worth, Texas 76104, United States
  • Baylor Medical Center of Irving
    Irving, Texas 75061, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02098083
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Karen McCain (Associate Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Mar 27, 2014
Start date
Nov 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jul 31, 2015

Study contacts

Karen J McCain, PT, DPT, NCS
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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