Clinical Trials Listing
A complete listing of Brooks' active clinical trials for 2010 is compiled below. For more information on any study, please contact Jodi Morgan, Clinical Research Liaison, at (904) 345-8987, or Floris Singletary, Research Manager, at (904) 345-8970.
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#435-2008 Psychosocial Factors Influence on Response to Falls Intervention program in older Adults
Purpose: The purpose of this study is to find out how individuals attitudes and thoughts, such as fear they might have about falling or pain, might affect the changes that they experience during intervention for a balance program.
Study Phase: Active Enrollment
Principal Investigator: Mark Bishop, PT, Ph.D. (352) 273-6112
Enrollment Criteria: Must be between 60 and 90 years old and had a history of two falls in the past 12 months.
#152-2007: Urinary Levels of a Knee Osteoarthritis Biomarker During the Early Period after ACL Reconstruction
Purpose: To determine if urinary levels of CTX-II are elevated in the early period following ACL reconstruction. To examine the association of urinary levels of CTX-II with self report of function in the early period following ACL reconstruction.
Study Phase: Active enrollment through March 2010
Principal Investigator: Terese L. Chmielewski, Ph.D., PT, (352) 273-6104 or tchm@ufl.edu
Enrollment Criteria: Participants must be age 15-30 years old and receiving rehabilitation at Brooks Center for Sports Therapy. They cannot have had prior knee surgery and must agree to refrain from high-impact activities until after the T3 test session. Also looking for control subjects who are 15-30 years old who have had no lower extremity injury.
#09-059 Assessment of Proposed Risk Factors for Knee Injuries in High School Males and Female Athletes
Purpose: To determine the biomechanical differences in movement patterns between male and female high school athletes. The secondary objective is to prospectively determine the risk for two knee injuries: anterior cruciate ligament injury and patellofemoral pain syndrome.
Study Phase: Active enrollment at Brooks Center for Sports Therapy only
Principal Investigator: Michelle Boling. Ph.D., LAT, ATC (904) 620-1563 or m.boling@unf.edu
Enrollment Criteria: Participants must be enrolled in freshman to senior year of high school at Nease or Ponte Vedra High school. They must have specific intent of participating in Junior Varsity or Varsity sports.
#610-2009 Musculoskeletal Pain in Uutpatient Physical Therapy Settings: Prevalence and Risk Factors
Purpose:To Establish prevalence rates of patients receiving outpatient physical therapy services for musculoskeletal conditions based on primary admitting diagnoses in a racially and ethnically diverse large metropolitan area. 1. Investigate the influence that demographic variables have on musculoskeletal conditions based on the anatomical region involved. 2. Investigate baseline and follow-up pain measures over the course of physical therapy treatment to determine if differences exist based on anatomical region.
Study Phase: Active Enrollment
Principal Investigator: Jason Beneciuk, PT, (904) 303-2103 or beneciuk@phhp.ufl.edu
Enrollment Criteria: All 2008 patients that were evaluated by a physical therapist at Brooks outpatient facilities with a primary admitting musculoskeletal diagnosis. Retrospective chart review and data abstraction only for certain ICD 9 codes.
Investigation of the STarT Back Screening Tool in Physical Therapy Settings
Purpose: The purpose of this study is to validate and refine the STarT Back screening tool in physical therapy settings, to determine if it may be a useful adjunct for effective management of patients with low back pain.
Study Phase: Active Enrollment
Principal Investigator: Steven George, PhD, (352) 273-6432 or szgeorge@phhp.ufl.edu
Enrollment Criteria: Must be ≥ 18 years of age and have a low back pain related diagnoses
#05-027: The Learning Trajectory for Patients with Spinal Cord Injury and the Teaching Trajectory for Spinal Cord Injury Nurses in a Rehabilitation Setting
Purpose: To investigate the best ways for a rehabilitation nurse to teach a patient with a SCI and how to facilitate learning.
Study phase: Active Enrollment
Principal Investigator: Barbara Olinzock, Ph.D., (904) 620-1467 or b.olinzoc@unf.edu
#19-2009: Locomotor Adaptability after Spinal Cord Injury and Training- Pilot
Purpose: To determine if rehabilitation targeting adaptive waling features can improve the capacity for effective home and community ambulation after iSCI (incomplete). Also designed to determine characteristics of individuals which may benefit most from such training and identify the neural mechanisms of locomotor adaptability post iSCI.
Study Phase: Active Enrollment
Principal Investigator: Andrea Behrman, Ph.D., (352) 273-6117 or abehrman@phhp.ufl.edu
Enrollment Criteria: Must be 18 years of age or older with first time incomplete spinal cord injury. >12 months post injury and discharged from in-patient and outpatient rehabilitation.
#313-2006: Restoring Walking in Non-Ambulatory Children with Severe Chronic Spinal Cord Injury ("Kids STEP")
Purpose: To determine if locomotor training can restore voluntary stepping in the absence of or with minimal voluntary movement in some individuals with severe chronic spinal cord injury.
Study phase: Active Enrollment
Prinicipal Investigator: Andrea Behrman, Ph.D., (352) 273-6117 or abehrman@phhp.ufl.edu
Enrollment Criteria: Children must be between the ages of three and ten years old and have experienced an incomplete spinal cord injury. They must have been previously ambulatory and now have very limited leg movement.
#116-2008 Improving Stroke Rehabilitation: Spacing Effect and D-Cycloserine
#2007-044 Late Development of Epileptiform Activity on Electroencephalography in Cerebral Cortical Infarction
Purpose: The purpose of this study is to identify the percentage of patients with a history of stroke who later develop changes on an electroencephalogram (EEG), a study that records brain waves, which could be a risk for developing seizures.
Study Phase: Active Enrollment
Principal Investigator: Nader Antonios, M.D. (904) 244-9514
Enrollment Criteria: Participants must have had a stroke between 6 months and 5 years ago.
#262-2005: Locomotor Experience Applied Post Stroke ("LEAPS")
Purpose: To compare two different treatment interventions to improve walking after stroke.
Study phase: Data Analysis
Principal Investigator: Pam Duncan, Ph.D., (919) 286-3399 ext. 239
Enrollment Criteria: Participants must be screened within 45 days of stroke onset. They may be screened at Brooks Rehabilitation Hospital, referred by clinicians within the community or self referred.
LEAPS Methodology Published Article
#H501-2006: Matching the Needs of Stroke Patients with Caregiving Resources to Improve Outcomes
Purpose: To develop a decision making tool to target potential issues prior to patient discharge from facility.
Study phase: Data Analysis
Principal Investigator: Barbara Lutz, RN, Ph.D., (352) 273-6350 or bjlutz@nursing.ufl.edu
Enrollment Criteria: Patient must have had an inpatient rehabilitation stay at Brooks Rehabilitation Hospital. There also must be a caregiver involved.
#472-2001: Treating Intention in Aphasia: Neuroplastic Substrates
Purpose: To develop a treatment for increasing language function in nonfluent aphasics.
Study phase: Data Analysis
Principal Investigator: Bruce Crosson, Ph.D., (352) 376-1611 ext 5329 or Local Contact: Cecila Brooks (904) 858-7260
Enrollment Criteria: Participants must be greater than 6 months post onset of stroke and have difficulty communicating. Must have been right handed prior to stroke and cannot have a history of seizures.
#06-00551300: The Brain Hemorrhage Cognitive Recovery Study
Purpose: To establish a natural history of cognitive recovery in survivors of spontaneous and warfarin-associated ICH (intracerebral Hemorrhage) and compare the cognitive recovery to that observed in ischemic subtypes of stroke.
Study phase: Data Analysis
Co-Principal Investigators: Thomas Brott, M.D., Trevor Paris, M.D., and Beth Rush Ph.D., (904) 953-7286 or brott.thomas@mayo.edu
Enrollment Criteria: Participants must have experienced an ischemic stroke or intracerebral hemorrhage and were admitted to Brooks Rehabilitation Hospital within the first 3 weeks post onset. Also looking for volunteers from the community who are "stroke free."
Brain Hemorrhage Cognitive Recovery Study Brochure
#2005-054: Local Identification and Outreach Networks (LIONS) for Stroke Trial
Purpose: To see if a new treatment (Pioglitazone) will prevent future strokes and heart attacks among persons with a recent stroke or transient ischemic attack (TIA)
Study phase: Active enrollment through December of 2010
Principal Investigator: Scott Silliman, M.D. (904) 244-9945 or Scott.silliman@jax.ufl.edu
Enrollment Criteria: Participants must have had an stroke or TIA within the past 180 days and cannot be diabetic or taking any insulin related medications.
#335-2007: Translating Motor Learning and Neural Plasticity Principles to Stroke Care at Brooks Rehabilitation Hospital: From Efficacy to Effectiveness
Purpose: To translate principles of neural plasticity and motor learning into the stroke program of care at Brooks Rehabilitation Hospital. Practice is the known strongest variable for motor learning to occur and task-related practice is advocated during stroke rehabilitation to improve functional performance of daily activities. Concordant studies of neural plasticity indicate that repetition of a newly learned (or relearned) movement sequence is required to induce lasting neural changes.
Study phase: Data Analysis
Principal Investigator: Trevor Paris, M.D. (904) 858-7602 or trevor.paris@brookshealth.org
Co-Prinicipal Investigator: Dorian Rose, Ph.D., PT, (352) 273-5278 or dkrose@phhp.ufl.edu
Enrollment Criteria: Participants must have had a CVA and a patient of Brooks Rehabilitation Hospital.
# 422-2008 Mechanisms of Restoring Gait Post-Stroke: Role of the Ankle Plantarflexors
Purpose: The purpose of this research program is to develop and evaluate evidenced-based therapeutic interventions that promote restitution of impairments that will maximize functional outcomes post-stroke. The specific objective of this application is to evaluate a targeted plantar flexor strengthening program on the restitution of the paretic limb contribution to gait.
Study Phase: Active Enrollment- Health Care Plaza only
Principal Investigator: Dorian K. Rose, Ph.D., PT (352) 273-8307 or dkrose@phhp.ufl.edu
Enrollment Criteria: Participants must have had a stroke within the past 12 months and referred to the Health Care Plaza for outpatient physical therapy.
#139-2007: Neuro-Cognitive Subtypes of Traumatic Brain Injury: Revelance to Cognitive Rehabilitation
Purpose: To identify clinically-meaningful neuro-cognitive subtypes of severe traumatic brain injury survivors using functional magnetic resonance imaging (fMRI) and to determine their differential responsiveness to cognitive rehabilitation using a brief trial of goal management.
Study phase: Active Enrollment
Prinicipal Investigator: William M. Perlstein, Ph.D. (352) 273-6139 or (352) 294-0336 or wmp@phhp.ufl.edu
Enrollment Criteria: Participants must have severe TBI 1-2 years post injury and also 10 neurologically healthy adults.
#08-2009: The Effects of Goal Management with Mild TBI Veterans
Purpose: The purpose of this Phase I study is to test an innovative treatment, Goal Management Training for executive dysfunction in veterans with mild TBI. The pilot testing of this treatment will allow the development of standardized procedures and in turn the development of a manual of procedures that can be exported for use in a subsequent randomized clinical trial.
Study Phase: Active Enrollment
Primary Investigator: J. Kay Webbs, PhD, BCBA-D Contact: Julia.waid-ebbs@va.gov
#UF03-2008-108 TBI-PBE: Traumatic Brain Injury- Practice Based Evidence
Purpose: To identify patient characteristics, including co-morbidity and complications, which explain variation in outcomes for TBI pts in acute rehabilitation. Identify medical procedures and therapy interventions or combinations of procedures and interventions associated with better outcomes, while controlling for patient characteristic. It is also designed to determine whether specific impairment by specific therapy interactions are associated with better outcomes.
Enrollment Phase: Active Enrollment through May of 2011
Co-Principal Investigator: Dr. Cynthia Beaulieu, Ph.D., ABPP-Cn, (904) 858-7651 or Cynthia.Beaulieu@brookshealth.org