Current rehabiliation clinical trials
There are many exciting rehabilitation clinical trials that are of interest to neurologic physical therapists. Below you will find a sampling of these trials, grouped by diagnosis. Each entry contains basic information regarding the trial and its principal investigator. Please see the NIH & Clinical Research web site for more information.
If you would like a clinical trial included on this list please email Andy Packel, PT, NCS.
- Balance & Falls
- Brain Injury
- Degenerative Diseases
- Spinal Cord Injury
- Stroke
- Vestibular Rehabilitation
- Other
Comparison of post-SCI locomotor training techniques: This proposal will assess, in individuals with chronic incomplete SCI, responses to a BWS-assisted treadmill training regimen under one of three training conditions: 1) passive (manual)-assisted stepping, 2) active (FES)-assisted stepping, or 3) non-assisted (voluntary) stepping. These studies will allow us to compare the efficacy of rehabilitation strategies aimed at improving functional mobility in individuals with SCI. In addition, they will provide information about neural and cardiorespiratory bases of these functional changes. Principal Investigator: Field-Fote, Edelle, University of Miami Medical School, Coral Gables, FL.
Differential effects of robotic vs. manually-assisted locomotor training: The primary objective of the proposed research is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training using body weight support and a treadmill on the sub-tasks comprising the task of walking (propulsion, transition from stance to step, stepping, and equilibrium). Principal Investigator: Behrman, Andrea, University of Florida, Gainesville, FL.
Kids STEP Study: The Kids STEP Study is investigating walking recovery in children with chronic, severe, incomplete spinal cord injury. The study is funded for two years by the Craig H. Neilsen Foundaion. The official title of the project is Restoring walking in non-ambulatory children with severe chronic SCI. This project is a collaborative effort among researchers at the University of Florida and physicians at Brooks Rehabilitation Hospital. The Kids STEP Study aims to investigate the use of locomotor training for restoring ambulation in children with chronic, severe SCI as well as the neural substrates mediating walking recovery. Principal Investigators: Andrea Behrman, PhD, PT; Co-PI: Dena Howland, PhD, OT; Project Coordinator: Emily Fox, MHS, DPT, NCS.
For more information please see http://locomotor.phhp.ufl.edu/KidsStepStudy
Clinical Assessment of a Massed Practice Therapy Device: The primary aim of the proposed study is to determine in a randomized, controlled, single blind parallel clinical trial whether the use of this innovative biofeedback technology of Active Repetitive Motion (ARM) therapy in a home environment will increase function and improve the cognitive, emotional, and physical health of people with stroke and in this potentially cost effective manner. Principal Investigator: Koeneman, James, Kinetic Muscles, Inc, Tempe, AZ.
Examining Parameters of Constraint-Induced Therapy: The purpose of this project is to ask questions related to constraint and intensity. The 3 specific aims are 1. to determine if CIT results in better outcomes than unconstrained functional training of equivalent time intensity and task structure, 2. to determine if CIT, provided by on site trainers, results in better outcomes than a combination of brief on-site training followed by home training and telephone supervision, and 3. to determine if a booster session of CIT intervention results in significantly improved functional gains. Principal Investigator: Light, Kathy E., University of Florida, Gainesville, FL.
Fast Treadmill Training/Functional Electrical Stimulation to Improve Walking: The overall goal of the project is to develop a physiologically based intervention to improve functional ambulation in individuals who have sustained a stroke. The Specific Aims are to: 1) develop and test a fast treadmill training and functional electrical stimulation (FastFES) intervention that improves the walking patterns and energy efficiency during treadmill walking in individuals who have sustained a stroke, 2) develop and test a 12-week training protocol using FastFES to improve body structure and function in individuals who have sustained a stroke, and 3) demonstrate the feasibility and potential effects of FastFES training compared to traditional treadmill training on body function, activity, and participation in individuals who have sustained a stroke. Principal Investigator: Binder-Macleod, Stuart, University of Delaware, Newark DE. For more information please see: http://www.udel.edu/PT/Research/fastFES/
FES for foot-drop in hemiparesis: The primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulator on lower limb motor relearning among chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with an AFO. Principal Investigator: Chae, John, Case Western Reserve University, Cleveland, OH.
Investigation of BrainPort® balance device training for balance improvement post-stroke: Primary aim for this study is to assess the safety and efficacy of BrainPort® balance device training for people with balance deficits post-stroke. The BrainPort is a device that provides head/body position information to the patient via electrotactile stimulation on the tongue. A multi-site pilot study is being conducted with patients that have completed conventional rehabilitation and have ongoing balance deficits. Participating clinical sites are University of Wisconsin, Madison (PI: Mary Beth Badke, PT, PhD), University of Kansas Medical Center (PI: Nandini Deshpande, PT, PhD), Physical Therapy Center of Horseheads, NY (PI: Joyce Wasserman, PT), and Rehabilitation Hospital of Indiana (PI: Shashank Dave, DO). Study Director: Monica Metea PhD, Wicab Inc., Middleton, WI
For more information please see http://www.wicab.us/clinical_trials.html
Locomotor experience applied post-stroke: The objective of this 5-year, phase-III, single-blind, multi-site randomized clinical trial is to assess if there is a difference in the proportion of people who successfully recover walking ability between a specialized locomotor training program that includes use of body weight support and a treadmill as a rehabilitation modality provided 2 months post-stroke or 6 months post-stroke and a non-specific, low intensity exercise (control) intervention. Principal Investigator: Duncan, Pamela, Duke University, Chapel Hill, NC.
Mechanisms and Rehabilitation of Cerebellar Ataxia: The cerebellum is a part of the brain important for coordination and learning of new movements through practice. In these experiments, we will work to understand how to improve movement coordination and motor learning abilities of people with cerebellar damage. We will also study the effects of a rehabilitation program designed to improve balance and walking. Principal Investigator: Bastian, Amy, Kennedy Krieger Research Institute, Baltimore, MD.
A Randomized Exercise Trial for Wheelchair Users: This proposed randomized-controlled trial will test the effectiveness of a behavioral intervention to promote physical activity adoption and maintenance among people with mobility impairments. One-hundred eighty manual wheelchair users will be randomly assigned to an intensive 6-month, home-based intervention or a minimal-contact control group and will be followed for another 6 months after the intervention ends. In this study, we aim to assess: (1) the effectiveness of the intervention for promoting physical activity adoption and maintenance, (2) the physical and psychosocial effects of the intervention, and (3) the complex interplay of factors that influence the effectiveness of the intervention. Principal Investigator: Grobe-Froehlich, Katherine, University of Kansas, Kansas City, KS.