Clinical Trials Listing
A complete listing of Brooks' active clinical trials for 2012 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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#19-2009 Locomotor Adaptability after Spinal Cord Injury and Training- Pilot
Purpose: To determine if rehabilitation targeting adaptive walking 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.
#116-2008 Improving Stroke Rehabilitation: Spacing Effect and D-Cycloserine
Purpose: The purpose of this study is to test 2 interventions that might affect the impact of Constraint Induced Movement Therapy (CIMT): 1. Administration of d-cycloserine as an adjuvant that might increase learning rate 2. Delivery of the therapy over a longer period of time that might yield
greater retention of motor skills at 3 months.
Study Phase: Data Analysis
Principal Investigator: Stephen E. Nadeau, M. D, (352) 376-1611 ext. 6551 or snadeau@ufl.edu
Enrollment Criteria: Eligible subjects must be: Between the ages of 18-80 years of age, have a diverse ethnic background, have had a single unilateral hemispheric stroke > 6 months ago
and have a motor and functional criteria to enter the study (=CIMT eligibility criteria).
# 2005-054: (IRIS) Insulin Resistance Intervention after Stroke Trial Local Identification in conjunction with UF2007-113 (LIONS) Local Identification and Outreach Networks- A Demonstration Project
Purpose: The purpose of this study is 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
Principal Investigator: Scott Silliman, M.D., (904) 244-9945 or Scott.silliman@jax.ufl.edu
Enrollment Criteria: Participants must have had a stroke or TIA within the past 180 days and cannot be diabetic or taking any insulin related medications.
#: CP L300 -0801 Functional Ambulation: Standard Treatment vs. Electrical Stimulation Therapy (FASTEST) Trial in Chronic Post-Stroke Subjects with Foot Drop
Purpose: The primary purpose of the study is to determine the effectiveness of the L300 in improving gait parameters, function, and quality of life among stroke subjects (≥ 3 months post stroke) with foot drop.
Study Phase: Active Enrollment
Principal Investigator: Trevor Paris, MD, (904) 345-7373
Enrollment Criteria: Eligible subjects must be: at least 18 years of age, have had at least one stroke resulting in foot drop sufficient to require prior or current prescription for and/or use of an AFO, have the ability to safely walk 10 meters with assist of 1 person, be medically stable and meet the requirements for participation.
Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia
Purpose: To examines the effects of Verb Network Strengthening Treatment (VNeST) on lexical retrieval abilities in persons with moderate aphasia.
Study Phase: Active Enrollment
Prinicipal Investigator: Lisa Edmonds, Ph.D, CCC-SLP, Phone: 352-273-3728 or edmonds@ufl.edu
Enrollment Criteria: Participants must be a monolingual English speaking with diagnosis of aphasia They must have a severity rating of 50 to 80 on the Western Aphasia Battery, have no more than mild apraxia of speech and have cognition within age normal limits.
Aerobic Exercise and Neural Plasticity in Aphasia Treatment
Purpose: The specific purpose of this protocol is to determine if aerobic exercise can enhance the effects of aphasia therapy.
Study Phase: Active Enrollment
Principal Investigator: Bruce Crosson, Ph.D., at nossorc1@phhp.ufl.edu or (352) 376-1611 Ext 4108
Enrollment criteria: Participants must be adults of all races and genders, 6-month post-onset of their most recent left-hemisphere stroke (ischemic or hemorrhagic).
Neurobehavioral Effects of HYBRID vs. CIMT for Upper-extremity Hemiparesis Post-stroke
Purpose: To determine if impaired upper-extremity function post-stroke is better explained by learned non-use or impaired central neural drive. Two forms of upper-extremity rehabilitation – distributed CIMT and HYBRID (combined UE power training and functional task practice will be investigated.
Study Phase: Active Enrollment
Principal Investigator: Carolynn Patten, Ph.D., PT, Phone: (office) 352.376.1611 x4160, (mobile) 650.283.4568 or patten@phhp.ufl.edu
#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. To identify medical procedures and therapy interventions or combinations of procedures and interventions associated with better outcomes, while controlling for patient characteristic. To determine whether specific impairment by specific therapy interactions are associated with better outcomes.
Study Phase: Active Enrollment
Principal Investigator: Joseph J. Tepas, M.D., Sub-Investigator: Cynthia Beaulieu, Ph.D., ABPP-Cn, (904) 858 7651 or Cynthia.Beaulieu@brookshealth.org
#108-2009 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, Ph.D., BCBA-D at Julia.waid-ebbs@va.gov
#610-2009 Musculoskeletal pain in outpatient 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 PT treatment to determine if differences exist based on anatomical region.
Study Phase: Data Analysis
Principal Investigator: Jason Beneciuk, DPT, (904) 303-2103 or beneciuk@phhp.ufl.edu
Enrollment Criteria: 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.
#406-2009 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
#617-2009-Life Intervention and Independence for Elders (LIFE Study)
Purpose: The LIFE Study is a Phase 3, multicenter randomized controlled trial (RCT) designed to compare a moderate-intensity physical activity program to a successful aging health education program.
Study Phase: Active in follow up, Enrollment Complete
Principal Investigator: Marco Pahor, M.D., (352) 273-5919 or www.thelifestudy.org
Enrollment Criteria: Must be between 70 and 89 years old and not involved in regular physical activity or another research study involving lifestyle programs.
#2011-U-0624 New Physical Therapy Confidence
Purpose: Preparing confident and competent practitioners is a common goal among healthcare educational programs. The purpose of this study is to 1). Examine the confidence and self-efficacy of new physical therapists and 2). Determine how this confidence changes over time.
Study Phase: Active Enrollment
Principal Investigator: Mark Bishop, Ph.D., PT, (352) 273-6112 or bish@ufl.edu
Brooks Active Research Registry (BARR)
Purpose: The objective of this project is the development of a Research Registry for the purpose of: Obtaining, storing, and screening of PHI and the ability to share specific information via written informed consent with investigators who are conducting approved research studies at the Brooks Rehabilitation Clinical Research Center.
Study Phase: Active Enrollment
Principal Investigator: Floris Singletary, MS, (904) 345-8973 or floris.singletary@brookshealth.org
Urinary Incontinence in acute and post acute Rehabilitation
Purpose: The purpose of this retrospective study will be to examine rates on incontinence, outcomes of rehabilitation for urinary incontinence and the impact of urinary incontinence in acute and post acute rehabilitation settings
Study Phase: Active Enrollment
Principal Investigator: Mark Bishop, Ph.D., PT, (352) 273-6112 or bish@ufl.edu. Brooks Contact: (904) 345-7791 or cindy.neville@brookshealth.org