Shepherd Center - A Catastrophic Care Hospital

If you are interested in participating in a clinical trial, please contact the research coordinator listed for that particular clinical trial or complete the participation form to the right. The participation form will be forwarded to the program coordinator and you will be contacted by the appropriate person.

Clinical evaluation of mobility and seating devices, positioning supports, and horizontal support surfaces [272]

Principal Investigator: Stephen Sprigle, PhD, PT, GIT/CATEA

Study Description: Manufacturers are often interested in having their products evaluated by an independent facility with experience in seating and positioning. The purpose of this study will be to periodically clinically evaluate commercial supports and pre-production prototypes to identify indications and contra-indication of use. This study might help improve final designs before a support is marketed.

To participate in this study, you must:

• be 18 or older
• use a mobility or seating device, positioning support, or support surface

Contact: Email Michelle Nemeth, PT, or call 404-350-7661.

Risk of adverse outcomes after SCI: A longitudinal study [361]

Principal Investigator: James Krause, PhD

Study Description: This research investigates the risk factors for adverse health outcomes following spinal cord injury. Subjects will answer questions about their injury history, their health behaviors, their psychological status and their social support over a 10 year period.

To participate in this study, you must:

• spinal cord injury over at least 1 year duration
• age over 18 at the time of enrollment

Contact: Email Sarah Lottes or call 404-350-7581.

Muscle plasticity, fitness and health after SCI: improving glucose tolerance [367]

Principal Investigator: Kevin McCully, PhD

Study Description: The purpose of this study is to determine if exercise using electrical stimulation to the muscles in the legs will lead to improved glucose tolerance in people with complete SCI who either have diabetes or who are pre-diabetic.

To participate in this study, you must:

• 18 – 39 years old
• C6-T10
• AIS A or B
• Normal range of motion about the hip, knee and ankle joints
• Diabetes or pre-diabetes since the injury

Contact: Email Joy A. Bruce, PT, MS, NCS, or call 404-603-4611.

Evaluation of a NeuroRecovery Network (NRN) for functional, health, and quality of life improvements after SCI [383]

Principal Investigator: Sarah Morrison, PT

Study Description: The NeuroRecovery Network is a national collaboration of seven medical centers that provides an intensive clinical program of activity-based interventions to people with paralysis. Data collected from all centers enter a web-based database for analysis to optimize treatment plans. This project is funded and supported by the CDC and the Christopher and Dana Reeve Foundation.

To participate in this study, you must:

• Have a motor incomplete SCI (AIS C-D)with movement in the legs
• Have an SCI at T10 or above (an upper motor neuron injury)
• Have completed inpatient rehabilitation
• Be willing to attempt to wean off of anti-spasmodic medications
• Not have had botox in the last 3 months

Contact: Email Neile Manning, BSW, C-SWCM, or call 404-350-3102.

Development and validation of a clinical measure of wheelchair seat cushion degradation [396]

Principal Investigator: Stephen Sprigle, PhD, PT, GIT/CATEA

Study Description: The purpose of this study is to determine the life of a wheelchair cushion within real world use and to develop a valid clinical measure that can be integrated into the clinical setting to assess the point when seat cushion replacement is needed.

To participate in this study, you must:

• be 18 or older
• be a wheelchair and wheelchair cushion user

Contact: Email Julie Ray, BA, or call 404-350-7655.

The Spinal Cord Injury Model System (SCIMS) Program [398]

Principal Investigator: David F. Apple, Jr., MD

Study Description: The Spinal Cord Injury Model System (SCIMS) Program is funded by the National Institute on Disability and Rehabilitation Research (NIDRR). The program began in the mid-1970s, and is recompeted every five years. Shepherd Center first received its designation as a model system for care delivery to patients with spinal cord injury in 1982 and has continued to retain the designation every since. The current cycle is 2006-2011. SCIMS has a large data collection component, and because it is the largest of the current 14 model system grantees, Shepherd makes a significant contribution to date being stored and analyzed for the entire system at the National SCI Statistical Center at the University of Alabama-Birmingham. Additionally, research is conducted as part of this program, both at each individual location, and collaboratively. Currently, Shepherd Center is conducting two site specific research projects, on Seat Cushion Degradation, and on Employment After Injury. It is also collaborating with Craig Hospital on a research project on Aging with SCI, and is conducting a collaboration with five other model system grantees on the subject of Hope for Recovery After SCI.

Contact: Email Pat Duncan, BS, or call 404-350-7591.

Psychological status during inpatient rehabilitation and 1 year after onset: stress, coping, and expectation-hope for recovery [408]

Principal Investigator: James Krause, PhD

Study Description: This research is focused on evaluating psychological outcomes at 1 year following spinal cord injury with special attention to hope and expectation for recovery. Patients will be asked to answer questions about their life’s events, their feelings about those events, their social support, their coping methods and their personality traits. With this information it may be possible to better predict and prevent adverse psychological outcomes related to spinal cord injury.

To participate in this study, you must:

• Traumatic SCI admitted to Shepherd within 4 months of injury
• age over 18 at time of enrollment
• patients with cognitive impairment will not be included

Contact: Email Pat Duncan, BS, or call 404-350-7591.

Rehabilitation Engineering Research Center on Wireless Technologies - Facilitating user centered research: The Consumer Advisory Network [410]

Principal Investigator: Mike Jones, PhD

Study Description: The cornerstone of this project is an ongoing nationwide Survey of User Needs (SUN) on use and usability of wireless communications technology by people with disabilities. The results are used to educate the wireless industry and the general public in order to promote usability of accessible wireless devices and services for people of all ages and abilities. Additionally, we invite respondents to join our Consumer Advisory Network (CAN) whose members are periodically asked to participate in subsequent surveys, focus groups, and user testing of wireless technology.

To participate in this study, you must:

• 18 years of age or older
• people with any type of disability
• all levels of impairment (from minimal to considerable)

Contact: Email John Morris, PhD, or call 404-367-1348.

Rehabilitation Engineering Research Center on Wireless Technology (Wireless RERC) - Customer-driven usability assessment [414]

Principal Investigators: Mike Jones, PhD

Study Description: The cornerstone of this project is the creation and maintenance of a community website where readers can share information, post comments, and engage in dialogue about the use and usability of wireless technology by people with disabilities. In order to promote discussion and provide important information, the project team posts news items and commentary on a regular basis. Some of this material comes directly from user testing on wireless devices and services that the project team conducts with people with various disabilities. This user testing constitutes a key component of the project.

To participate in this study, you must: (these apply to the user testing only)

• Age 18 and older
• Some form of disability or limitation in physical or cognitive ability (vision, hearing, speaking, dexterity, mobility, cognition)

Contact: Email John Morris, PhD, or call 404-367-1348.

Evaluating the effects of an activity-based therapeutic exercise program for individuals with SCI [418]

Principal Investigator: Mike Jones, PhD

Study Description: The purpose of this study is to evaluate the effects from participation in an intensive, activity-based therapy program for individuals with chronic, motor incomplete spinal cord injuries (SCI). Participants will complete 24 weeks of activity based therapy (9 hours/week) beginning with a graduated treatment protocol determined by the subject’s physical exam at the time of entry into the study. The protocol includes robotic and manual locomotor training, over ground gait training, intensive resistance and plyometric training, and development sequencing. Many of these interventions will also incorporate electrical stimulation when appropriate. Each participant will be evaluated and allocated to a specific treatment protocol based on initial walking independence, spasticity and trunk stability. (BT Grant study)

To participate in this study, you must:

• Upper motor neuron, above T10-11, motor incomplete SCI (AIS C-D)
• 18-55 years of age at enrollment
• At least one year post injury
• Preserved tendon reflexes

Contact: Email Candy Tefertiller, DPT, NCS, or call 404-350-7788.

SCIRehab – Improving outcomes through practice-based evidence [421]

Co-Investigators: David Apple, MD and Deborah Backus, PhD, PT

Study Description: This study is being conducted in collaboration with Craig Hospital (Rocky Mountain Regional Spinal Injury System), and five other inpatient rehabilitation programs. The purpose of the study is to figure out which SCI rehabilitation interventions are most effective for improving neurologic recovery and functional independence, return to work, social participation, and quality of life after SCI, as well as decreasing medical complications and re-hospitalization in the first year after injury.

Contact: Email Deborah Backus, PhD, PT, or call 404-350-7599.

Innovative knowledge dissemination and utilization (KDU) for disability and professional organizations and stakeholders [436]

Principal Investigator: Lesley Hudson, MA

Study Description: The knowledge dissemination and utilization (KDU) study is a subcontract to Boston University for their grant from the National Institute on Disability and Rehabilitation Research (NIDRR). This project involves evaluating current literature published on several topics, chosen by Shepherd Center based on the expressed need of major stakeholders in SCI (the American Spinal Injury Association (ASIA) and the National Spinal Cord Injury Association (NSCIA). The information from this review of the literature will be disseminated to stakeholders to help educate and inform them about the evidence regarding particular topics.

Contact: Email Lesley Hudson, MA, or call 404-350-7582.

Relationship change following spinal cord injury [441]

Principal Investigator: Elisabeth Burgess, PhD

Study Description: The goals of this study are to examine how younger marital and cohabiting couples negotiate their relationship following SCI and to examine how their interactions with practitioners influence their experiences in the first months following injury. Additionally, the study seeks to understand how practitioners work with couples following injury. Interviews with counselors, chaplains, physicians, case workers, and educators who work with patients and partners are also sought.

To participate in this study, you must:

• Married or living together
• Under age 50
• Within one month of beginning rehabilitation

Contact: Email Alexis Bender, MA, or call 678-595-4080.

Phase I Trial — Rehabilitation from Spinal Cord Injury (SCI) with Enhanced Proprioceptive Feedback [448]

Principal Investigator: Deborah Backus, PhD, PT

Study Description: The purpose of this study is to evaluate how a device that combines active movement of the wrist and hand with simultaneous proprioceptive feedback affects function of the wrist and hand in people with tetraplegia.

To participate in this study, you must:

• C4-C6 tetraplegia
• AIS C or D
• 1 year post-SCI
• Can feel the direction of joint(s) motion of the wrist and hand the majority of times tested
• Some ability to move the wrist and hand

Contact: Email Kathy Kreger, or call 404-350-7397.

Clinical usability of a wound measurement device [449]

Principal Investigator: Stephen Sprigle, PhD, PT, GIT/CATEA
Study Description: A prototype wound measurement device is being tested by the wound specialty nurse. This hand-held device determines and captures wound boundaries to provide a digital documentation of wound progression.

To participate in this study, you must:

• be 18 or older
• currently be an inpatient with an open wound.

Contact: Email Cathy Koerner, RN, or call 404-350-3105.

The effect of combined resistance and plyometric training on locomotor recovery following incomplete SCI. [455]

Principal Investigator: Candy Tefertiller, DPT, NCS

Study Description: The purpose of this study is to determine if a protocol of intensive strengthening of lower extremity muscles impaired by a spinal cord injury (SCI) along with plyometric training will improve the quality and speed of walking for those individuals who have sustained a motor incomplete SCI. Participants in this study will complete three exercise sessions per week for a 12 week period of intensive strengthening and plyometric training. The quality and speed of over ground gait will be assessed prior to and after completion of the 12 week protocol for each participant.

To participate in this study, you must:

• Between 18-39 years of age
• Incomplete cervical (C1-C8) SCI more than 1 year ago
• Able to walk 50 feet with only one person assist and/or assistive device
• Demonstrate self-selected gait speed during 10m walk test less than 0.8m/s

Contact: Email Candy Tefertiller, DPT, NCS, or call 404-350-7780.

Usability evaluation of the tongue drive system [457]

Principal Investigator: Maysam Ghovanloo, PhD

Study Description: The purpose of this study is to evaluate the performance, user acceptability, and usability of the "Tongue Drive" assistive technology in accessing a personal computer and controlling a powered wheelchair.

To participate in this study, you must:

• Age 18-65
• Either using or suitable for alternative control
• Sitting tolerance at least 4 hours
• Some experience with computers
• Able to move tongue

Contact: Email Joy A. Bruce, PT, MS, NCS, or call 404-603-4611.

Multi-Center study to assess the validity and reliability of the Spinal Cord Independence Measure (SCIM III) [460]

Principal Investigators: Kimberly Anderson, PhD, UC Irvine, Deborah Backus, PhD, PT, Shepherd Center

Study Description: This project, led by Kimberly Anderson, PhD, at the University of California, Irvine, is a collaborative effort that will assess the validity, reliability, and sensitivity of the Spinal Cord Independence Measure (SCIM III) in measuring functional ability in persons with spinal cord injury (SCI) during their acute rehabilitation.

To participate in this study, you must:

• Be a current inpatient at Shepherd Center
• Have a spinal cord injury

Contact: Email Kathy Kreger, or call 404-350-7397

The use of wheelchairs, wheelchair cushions and other mobility assistive devices in everyday life [463]

Principal Investigator: Stephen Sprigle, PhD, PT, GIT/CATEA
Study Description: Understanding how wheelchairs and cushions are used is important for many reasons. Prescriptions can be improved, designs can reflect actual use and policy can be written to reflect use. This project will place sensors on your wheelchair and/or cushion for one week to monitor use.

To participate in this study, you must:

• be 18 or older
• use a wheelchair or other mobility assistive device.

Contact: Email Michelle Nemeth or call 404-350-7661, or email Sharon Sonenblum or call 404-385-0633.

The ABLE Scale: The development and psychometric properties of a new outcome measure for the spinal cord injury population [465]

Principal Investigator: Elizabeth Ardolino, PT, MS; Magee Rehabilitation

Study Description: The Activity-based Balance Level Evaluation (ABLE Scale) is a new tool to measure balance in people with spinal cord injuries (SCI). It is being created by the balance committee of the NeuroRecovery Network (NRN). This new scale combines items from other balance tools currently being used, with new sitting and walking items. The scale now needs to be tested to find out if any more changes are needed.

To participate in this study, you must:

• be at least 14 years old
• have a traumatic or non-progressive, complete or incomplete spinal cord injury
• ASIA Impairment Scale A, B, C, D
• be able to tolerate upright supported sitting for at least 1 minute.

Contact: Email Leslie VanHiel, MSPT, or call 404-350-7681.

Vascular Health after FES in Spinal Cord Injury [466]

Principal Investigators: Kevin McCully, PhD, Deborah Backus, PhD, PT, Keith Tansey, MD, PhD

Study Description: This study is an addition to the study #467: “The Effect of Electrically Stimulated Bike Training on Neurological Control of Cardiovascular Function In Individuals with Incomplete Tetraplegia: A Pilot Study” and involves measuring blood flow in the arms and legs of individuals with incomplete SCI who participate in the FES bike study. All tests will be made at the beginning and at the end of the training program. The only subjects that will be accepted for these measurements will be those who are enrolled in study #467.

To participate in this study, you must:

• C5-T1 tetraplegia
• AIS C
• 1 year post-SCI

Contact: Email Deborah Backus, PhD, PT, or call 404-350-7599.

The Effect of Electrically Stimulated Bike Training on Neurological Control of Cardiovascular Function In Individuals with Incomplete Tetraplegia: A Pilot Study [467]

Principal Investigator: Deborah Backus, PhD, PT

This study will investigate the variations in heart rate in people with both acute and chronic spinal cord injury (SCI), in order to see the effects of the SCI on control of the heart by the autonomic nervous system in people with tetraplegia (C5-T1).

To participate in this study, you must:

• C5-T1 tetraplegia
• AIS C
• 1 year post-SCI

Contact: Email: Alisen Martin or Megan Hector.

The Brain Motor Control Assay (BMCA) - Using Standard Electromyographic Techniques to Test Supraspinal Control of Spinal Cord Function in Spinal Cord Injury [468]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: The Brain Motor Control Assessment (BMCA) is a set of tests designed to determine how much control the brain has over the spinal cord following spinal cord injury (SCI). This is done by measuring the electrical activity in muscles during specific testing procedures. These recordings may also help us design more specific treatment plans for different patients.

To participate in this study, you must:

• Be male
• Be age 18-59 years old
• Either have an intact neurological system or have a spinal cord injury between T2 and T10
• Have time since spinal cord injury 6-24 months
• Have any ASIA Impairment Scale (A, B, C, D, or E)

Contact: Email Joy A. Bruce, PT, MS, NCS, or call 404-603-4611.

Effectiveness of augmented immediate video feedback on advanced wheelchair skill training [470]

Principal Investigator: Tai Wang, PhD, Georgia State University

Study Description: Studies have shown encouraging results in rehabilitation settings to analyze movement and provide real-time feedback to patients. The purpose of this study is to investigate the effectiveness of immediate video feedback for learning advanced manual wheelchair skills.

To participate in this study, you must:

• be 18 or older
• have an SCI diagnosis
• be naïve to advanced wheelchair skills, including wheelies, curbs and ramps
• currently be an inpatient or Day program rehab patient

Contact: Email Michelle Nemeth, PT, or call 404-350-7661.

Mobile Music Touch (MMT): Effects of tactile music instruction system on hand rehabilitation [474]

Principal Investigators: Ellen Yi-Luen Do, PhD, Georgia Tech and Deborah Backus, PhD, PT

Study Description: The purpose of this study is to see if a novel device called the Mobile Music Touch (MMT) can be used to improve hand function in people with tetraplegia due to SCI. The MMT uses the sense of touch to teach how to play musical instruments. The system consists of two main parts: 1.) a lightweight, wireless tactile glove, with one small vibration motor for each finger, and 2.) an associated computing device such as a cell phone, MP3 player, or computer. Volunteers will train 3 times a week (1 hour each session) for 4 weeks, and will be evaluated for sensory and motor improvements.

To participate in this study, you must:

• Be 18 – 50 years old, with C4-T1 tetraplegia
• Have ASIA Impairment Scale rating of A, B, or C
• Have the ability to move their individual fingers to press the keys on a musical keyboard
• Have greater than 1 year post-SCI

Contact: Email Kevin Huang or call 864-506-6027.

User acceptability of test male external catheters to the current users of latex everyday and extended wear male external catheters [477]

Principal Investigator: Ismari Clesson, RN

Study Description: The primary objective of this study is to determine the level of acceptance of the test male external catheter (Test MEC), as a urinary collection device, to the current users of everyday and extended wear latex male external catheters (MECs). The secondary objectives are to evaluate the following areas: urine leakage, ease of application and removal, and skin irritation.

To participate in this study, you must:

• Male at least 18 years of age
• Regularly use a self-adhesive everyday or extended wear male external catheters (condom catheters)
• Not allergic to latex

Contact: Email Ismari Clesson, RN, or call 404-350-7651.

Safety and efficacy of an intermittent catheter incorporating a novel catheter eyelet design – proof of principle [478]

Principal Investigators: Ismari Clesson, RN

Study Description: The primary objective of this study is to determine how completely the test intermittent catheter drains the bladder of subjects who use the currently marketed gel catheter Advance™ Plus. The amount of residual urine is estimated using a second catheterization. The secondary objectives are safety and subject acceptability.

To participate in this study, you must:

• 18 years and older
• Currently use Advance™ Plus catheter
• Have performed intermittent catheterizations (IC) for at least 3 months

Contact: Email Ismari Clesson, RN, or call 404-350-7651.

The effects of sensory, motor and perceptual impairments on upper extremity motor performance with the REJOYCE system [482]

Principal Investigator: Deborah Backus, PhD, PT

Study Description: The purpose of this study is to evaluate how people with poor movement control in their arms and hands, secondary to incomplete spinal cord Injury (SCI) or apraxia (due to stroke or head injury), perform a task on a device called the Rejoyce. In addition, we will see how performance on the game-like tasks in this study relates to how the brain is functioning.

To participate in this study, you must:

• Have apraxia due to a stroke or head injury, or incomplete tetraplegia due to a traumatic SCI that leads to an inability to use at least one arm or hand effectively
• Be 18-65 years old
• Have greater than 6 months post-stroke or head injury, or greater than 1 year post-SCI

Contact: Email Kathy Kreger or call 404-350-7397.

The Brain Motor Control Assessment (BMCA) – evaluating supraspinal control of spinal cord function in spinal cord injury during standing and testing in the Lokomat® [483]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: The Brain Motor Control Assessment (BMCA) is a set of tests designed to determine how much control the brain has over the spinal cord following spinal cord injury (SCI). This is done by measuring the electrical activity in muscles during specific testing procedures. The recordings for this study will be taken while the participant is either standing or walking in the Lokomat®. Using these recordings gives us a more refined assessment of how the brain can control spinal cord function after SCI and may help us design more specific treatment plans for different patients.

To participate in this study, you must:

• be male
• be 18-59 years old
• either have an intact neurological system or have a spinal cord injury between T2 and T10
• have time since spinal cord injury of 6 – 24 months
• have any ASIA Impairment Scale (A, B, C, D, or E)

Contact: Email Joy Bruce, MSPT, ABD, NCS or call 404-603-4611.

A multicenter, long-term follow-up study of the safety and efficacy of two dose levels of BOTOX® (Botulinum Toxin Type A) purified neurotoxin complex in patients with urinary incontinence due to neurogenic detrusor overactivity [484]

Principal Investigator: Janelle Foote, MD

Study Description: The purpose of this study is to gather information about the long-term safety and effectiveness of BOTOX® injections into the bladder in patients with accidental loss of urine due to neurogenic overactive bladder. This is an extension study offered to the remaining participants of an original Allergan protocol. This study will gather additional safety and efficacy data.

To participate in this study, you must:

• Have been in enrolled in the previous Allergan study.

Contact: Emial Nell “Winnie” Klein or call 404-367-1307.

Measurement of Simultaneous H-Reflexes in Multiple Lower Extremity Muscles of Subjects With or Without SCI During Rest and Stepping in the Lokomat ® [488]

Principal Investigator: Keith Tansey, MD, PhD

Study Description: This study will examine reflexes simultaneously in multiple muscles of the lower extremities of subjects with or without spinal cord injury (SCI). These reflexes will result from electrical stimulation of the spinal nerve roots in the low back while a subject is lying down and then while he is standing or stepping in the robotic gait orthosis called the Lokomat®. The reflexes will be recorded with standard electromyography (EMG) electrodes over multiple leg muscles. We will analyze these reflexes in order to understand how positional changes affect motor function in patients with SCI compared to subjects without SCI. This study will serve as a foundation for additional studies examining the effects of locomotor training on lower extremity function in persons with spinal cord injury.

To participate in this study, you must:

• Be male, age 18-59 years old
• Have an intact neurological system or spinal cord injury of any ASIA classification
• If SCI, have a spinal cord injury between C6-T10
• If SCI, have time since injury between 6-24 months

Contact: Email Joy Bruce, MSPT, ABD, NCS, or call 404-603-4611