BCAR is designed to assess the changes in neural activation (cortical reorganization) in the brain through fMRI scanning procedures and the changes in behavioral measures of motor control of reaching and grasping actions that pertain directly to constraint-induced (CI) therapy compared to that associated with standard and customary care. CI movement therapy consists of a family of therapies; their common element is that they induce stroke patients to greatly increase the use of an affected arm and hand for many hours a day over a period of 10 to 14 consecutive days. During the 2 weeks of CI therapy, each person is given a mitt to wear on the hand least affected by the stroke. Study participants will partake in the 2-week CI therapy either initially upon enrolling in the study or a year after enrolling. However, to assess what changes are occurring each participant will complete the 4 evaluations (at baseline, 1-month, 6-months and 12-months) and 3 fMRI scans (at baseline, 1-month, and 12-months).
The BION study involves three clinical trials designed to evaluate the effectiveness of strengthening the muscles in the affected arm after a stroke through electrical stimulation. The affected muscles are stimulated by a device called a BION™. The BION™ is a tiny glass capsule about the size of a grain of rice that is implanted into the muscles to be strengthened. The BION™ emits an electrical pulse only when it receives commands and energy by radio waves from a specially designed ring that is placed on the arm when the muscles are to be exercised. The studies involving the use of the BION™ under the direction of Lucinda Baker, PhD and Carolee Winstein, PhD are as follows:• Shoulder subluxation: Some people who have had a stroke suffer from weakened shoulder muscles, which may cause shoulder subluxation, or separation of the shoulder joint. For this study, participants are randomly assigned to either receive surface stimulation (electrical stimulation of the muscles using sticky electrodes placed on the skin) or stimulation by a BION™ implanted into the muscles to be strengthened. For six weeks, each participant completes 2 sessions per day of stimulation with the intention of strengthening the muscles enough to lift the arm and pull it back into the shoulder. When each person finishes the six weeks, he/she is followed for another six weeks to determine how well the muscles maintain any strength gained from the electrical stimulation. • Wrist contractures: Some people as a result of their stroke are unable to move or use the hand of the affected arm. Unless the joints of the wrist and fingers move, they can develop contractures. To avoid this, exercises that stretch the muscles of the joints can be done each day. We want to know if stretching the wrist and fingers without the use of your other hand or someone else would give better results. However, because some of your muscles in the arm and hand are paralyzed and do not work, the only way to activate them is to stimulate them with small electrical pulses. For this study, participants are randomly assigned to either receive surface stimulation (electrical stimulation of the muscles using sticky electrodes placed on the skin) or stimulation by a BION™ implanted into the muscles to be strengthened. For six weeks, each participant completes 2 sessions per day of stimulation. When each person finishes the six weeks, he/she is followed for another six weeks to determine how well the muscles maintain any strength gained from the electrical stimulation. • Recovery of Hand Function: BION™ Induced Training Post-Stroke (BITS) is for people who are 3 to 12 months post-stroke and have limited wrist and finger movement or function, but no contractures. BITS combines the use of the BION™ for stimulation of the weakened muscles in the wrist and fingers with Constraint-Induced (CI) Therapy. CI Therapy involves wearing a padded mitt on the less affected hand for six weeks. During the CI Therapy, the participant practices functional activities under the guidance of a rehabilitation expert three days per week, and on his/her own each day. Each participant will have a BION™ implanted in the muscles to be strengthened. Over a 12-week period, participants will complete a combination of CI Therapy and BION™ stimulation with the intention of increasing the functional use of the affected hand.
The goal of this Phase I trial is to determine the rehabilitative effects gained through the use of a novel computer generated virtual scenario (VS), alone and with a protocol of constraint-induced therapy (CIT), for stroke rehabilitation. Efficacious results of a therapeutic protocol of VS and/or VS enhanced CIT (VS-CIT) could positively impact the lives of stroke survivors through enhanced recovery. The technology we seek to verify through this Phase I STTR proposal could be applied to products directed toward the rehabilitation of stroke victims and perhaps lessen the over 51 billion dollar estimated annual burden from stroke-related disability. Future goals involve determining whether the technology could be developed into products to be used by individuals with disabilities of different causes and types.
The ICARE study is about arm and hand recovery after stroke. Principal Investigators, Dr. Carolee Winstein (USC), Dr. Steven Wolf (Emory University, Atlanta, GA), and Dr. Alexander Dromerick (National Rehabilitation Hospital, Washington DC) We are testing an evidence-based arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice (e.g. handwriting, carrying groceries) compared to two standard types of outpatient occupational therapy: 1) Dose Equivalent Usual & Customary Care (DEUCC) 30 hours of occupational therapy scheduled 3x/week over 10 weeks and 2) Usual & Customary Care (UCC) delivered at the dosage indicated on your prescription and common for that outpatient setting. UCC may vary but is likely to be less than 30 hours and in some case may be not therapy. We will randomize 360 individuals from multiple sites within three centers (Atlanta GA, Los Angeles CA and Washington DC) within 14 to 106 days of stroke onset with mild to moderate upper extremity impairment.For more information, contact:Monica A. Nelsen, PT, DPTICARE Clinical Project Manager, Clinical Research FacultyTel: (323) email@example.comGrant #: U01 NS056256Sponsor: National Institutes of Health, National Institute of Neurological Disorders and Stroke
The overall goal of the USC/UT Exploratory Center for the Interdisciplinary Study of Neuroplasticity and Stroke Rehabilitation is to gain a better understanding of how critical factors such as the focus of therapy (skilled learning vs. motor activity), the intensity and timing of therapy, patient motivation, mental practice and the neural mechanisms that underlie the recovery process interact to impact the effectiveness of rehabilitation therapy. The Center brings together investigators from the biological, behavioral, computational and engineering sciences with expertise in methods encompassing molecular and cell biology, behavioral neuroscience, bioinformatics, computational modeling, virtual environment technology, haptics, biostatistics and physical therapy to address this complex problem. The aims of the planning grant are:• To broaden our understanding of the key factors that modulate neuroplasticity and the recovery of function after brain injury.• Build a foundation of interdisciplinary scientific knowledge that can be used in the development of innovative and more effective therapeutic interventions to enhance the health and independence of persons with post-stroke disabilities.• Provide an interdisciplinary training opportunity for (basic science and clinical) graduate and post-doctoral students to develop as independent research scientists equipped to work both within and across scientific disciplines.For additional information on the ISNSR project, visit: http://www.usc.edu/schools/medicine/departments/cell_neurobiology/research/isnsr/
Locomotor Experience Applied Post-Stroke (LEAPS) trial, is a collaborative effort between Dr. Pamela Duncan (Principal Investigator, Duke University), and co-Principal Investigators Dr. Katherine Sullivan (USC), and Dr. Andrea Behrman (University of Florida) and five community-based rehabilitation hospitals in Southern California and Florida . Participating centers include:• Long Beach Memorial Rehabilitation Center in Long Beach, California• University of Southern California Physical Therapy Associates, Los Angeles, California• Sharp Memorial Rehabilitation Center in San Diego, California• Brooks Rehabilitation Hospital in Jacksonville, Florida• Florida Hospital in Orlando, FloridaOf the 750,000 Americans who have a stroke, approximately 75% will experience physical disability that impairs their ability to walk. The National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research has funded a $13.5 million 5-year grant to investigate the effectiveness of rehabilitation interventions specifically designed to improve walking in the first year after stroke.Researchers will study 400 acute stroke patients, ages 18 and older, to ascertain the best timing to begin physical therapy and the effectiveness of a particular therapy method to reduce walking disabilities after a stroke. The focus of the trial is a clinic-based program, in which patients practice walking on a treadmill. The multi-site, randomized trial will assess whether there is a difference in the proportion of subjects who successfully recover walking ability using this walking therapy versus a group given a therapist supervised, home-based, exercise program at 1-year post-stroke.
USC’s Division of Biokinesiology and Physical Therapy is one of 21 Centers who participated nationally in this phase III randomized clinical trial. Professor Dr. Winstein, PhD, PT, FAPTA, is the USC site Primary Investigator for the Everest Study. Dr. Jeanine Yip, DPT, NCS, is the study coordinator.The primary objective of this study is to determine the effectiveness of targeted subthreshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis (a motor weakness in one half of the body) affecting the upper extremity (shoulder, arm, wrist, hand) following a stroke. In addition to evaluating changes from baseline level, efficacy will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation. Thus, the two study groups will be compared to determine the degree to which motor function of the affected limb can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.A secondary objective is to assess the safety of study procedures, including the neurosurgical interventions and the targeted subthreshold epidural cortical stimulation delivered concurrent with rehabilitation activities in patients suffering from hemiparesis affecting the upper extremities following a stroke.This study is a prospective, randomized, blinded multicenter safety and effectiveness study of patients with upper extremity motor deficit resulting from a stroke at least four months prior to enrollment. Up to 400 patients will be enrolled in order to obtain a total of 174 patients appropriate for randomization and possible stimulation system implant procedures. Of these patients, 110 will be randomized to undergo implant procedures and subsequent cortical stimulation concurrent with rehabilitation activities (the investigational treatment group). The other 64 patients will be randomized to act as rehabilitation-only controls and undergo the same rehabilitation activities without cortical stimulation (the control group). Outcome measure assessments will be via standardized, reliable, and validated tests of function, disability, and quality of life.
This study was an NSF funded study focused on the use of social robots in therapeutic settings to assist in upper extremity rehabilitation after stroke.We evaluated the ability of the social robot to provide motivation and instruction as people practice using both limbs in a goal-directed reaching game.
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