Here is a list of current studies/initiatives that Shepherd Center is participating in to help increase our understanding of Spinal Cord Injuries. These studies are not recruiting volunteers at the present time.
The Impact of Cognitive Functioning on Outcomes following SCI [288]
Principle Investigator: Stephen Macciocchi, PhD, ABPP
Study Description: Involves determining the impact of co-occurring TBI on SCI rehabilitation outcomes at discharge from inpatient rehabilitation and at one-year follow-up. 60% of persons who sustain an SCI also sustain a TBI. Outcome data is currently being analyzed.
Contact: Email Stephen Macciocchi, PhD, ABPP, or call 404-350-7553.
Changes in interface pressure in variable position wheelchairs [358]
Principle Investigators: Stephen Sprigle, PhD, PT
Study Description: The purpose of this study was to determine changes in interface pressures between the subject’s body and the support surfaces of a wheelchair as it transitions into different positions. Tilt-in-space, recline and standing positions will be studied using the same wheelchair system (Levo).
Contact: Email Michelle Nemeth, PT, CCRP, or call 404-350-7661.
Predicting personal care hours for patients with SCI [369]
Principal Investigator: Shari McDowell, PT
Study Description: The purpose of the study is to determine the number of personal care hours required in the home for patients with spinal cord injury after they are discharged from inpatient rehabilitation. This study will allow the researchers to better predict the number of personal care hours that are necessary for patient care in the home and will be helpful to families and patients in planning for care.
Contact: Email Shari McDowell, PT, or call 404-350-7619.
Outcomes of cervical immobilization vs. nonimmobilization following surgery in quadriplegia [385]
Principal Investigator: David Apple, MD
Study Description: This is a retrospective study (chart review) to determine if cervical immobilization after surgery is more effective than nonimmobilization in reducing or preventing complications. If so, what duration of time in the cervical collar is optimal? Is one surgical technique superior to another in reduction of complication rate?
Contact: Email Kim Gilbert, MD.
A multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the safety and efficacy of repeat treatment with two dose levels of BOTOX® (Botulinum Toxin Type A) purified neurotoxin complex followed by a treatment with BOTOX® in patients with urinary incontinence due to neurogenic detrusor overactivity [389]
Principal Investigator: Jenelle Foote, MD
Study Description: This study involves utilizing botox to treat detrusor overactivity in neurogenic bladder. The aim is to decrease urinary leakage between intermittent catherizations and evaluate the most effective dose.
Contact: Email Nell Klein, RN, CCRP, or call 404-367-1307.
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.
Contact: Email Cami Godsey, or call 404-350-7655.
The Effects Of FES Cycle Ergometry Training To Improve Balance And Locomotion In Individuals With Incomplete SCI [407]
Principle Investigator: Deborah Backus, PhD, PT
Study Description: The purpose of this study was to see if people with incomplete SCI (AIS C) can benefit from training on the functional electrical stimulation bike. The investigators of this study want to see if this bike can improve the strength in the legs, and improve walking in people with motor incomplete (ASIA C) spinal cord injury.
Contact: Email Deborah Backus, PhD, PT, or call 404-350-7599.
Using the Spinal Cord Injury Independence Measure III (SCIM III) to measure functional outcomes in post acute rehabilitation after spinal cord injury [413]
Principal Investigator: Sarah Morrison, PT
Study Description: The purpose of this study is to analyze functional gains, as measured by the SCIM-III that occur during a post acute rehabilitation program. The sensitivity of the assessment tool as well as the floor and ceiling effects of the SCIM-III scoring will be evaluated.
Contact: Email Sarah Morrison, PT, or call 404-350-7676.
An Open-label, Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects with Neurogenic Bladder following Spinal Cord Injury [417]
Principle Investigator: Bruce Green, MD
Study Description: Shepherd Center is one of several hospitals around the US participating in a Phase II clinical trial of a bioengineered bladder called the Tengion Neo-Bladder Augment(TM). The Neo-Bladder is made from a combination of the patient's healthy cells taken from a tissue sample and grown in a Tengion laboratory. The Neo-Bladder is surgically attached to the patient's native bladder to expand its capacity. This procedure improves the patient's health by reducing the risk of urinary tract infections and kidney damage in addition to stopping urinary leakage.
Contact: Email Nell Klein, RN, CCRP, or call 404-367-1307.
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.
Improving transfer mobility and wheelchair propulsion using real-time feedback [423]
Principal Investigator: Chris Maurer, MPT, ATP
Study Description: This study is investigating the use of video feedback to improve rehabilitation training. Training will be supplemented using “Dartfish,” a real-time video-based training software most commonly used by coaches and trainers for sports applications. Training will focus on transfers, wheelchair propulsion, mobility and ADL related functional skills.
Contact: Email Chris Maurer, MPT, ATP, or call 404-367-1333.
Multiple-dose efficacy and safety study of XP19986 in subjects with spasticity due to spinal cord injury [435]
Principal Investigator: David Apple, MD
Study Description: This study is evaluating the safety and effectiveness of a sustained release form of Baclofen, an anti-spasticity medication. Three different doses will be tested and since the trial has a “cross-over” design all patients enrolled will eventually get the medication even if they start out in the placebo group.
Contact: Email Ismari Clesson, RN, CCRP, or call 404-350-7651.
Evaluation of the pretest clinical score for the diagnosis of heparin induced thrombocytopenia (HIT) in SCI and TBI [443]
Principal Investigator: Ismari Clesson, RN
Study Description: This is a chart review study by a medical resident. The goal of this study is to assess both SCI and TBI inpatient populations for risk factors for the development of heparin induced thrombocytopenia (“HIT”). HIT is an immune-mediated adverse drug reaction to heparin resulting in a prothrombotic state. It is estimated to occur in up to 5% of patients receiving unfractionated heparin.
Contact: Email Anna Elmers, MD, or call 404-520-8293.
Year 2 follow-up of patients with the NeuRx RA/4 ventilatory assist device [445]
Principal Investigator: Michelle Nemeth, PT
Study Description: The purpose of this study is to follow patients who participated in the “Electronic activation of the diaphragm for ventilatory assist – Neurx RA/4 ventilatory-assist, percutaneous, multi channel, neuromuscular stimulator” study for their second year post implantation.
Contact: Email Michelle Nemeth, PT, CCRP, or call 404-350-7661.
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.
Contact: Email Cathy Koerner, RN, or call 404-350-3105.
AstroWheelie: Wheelchair controlled game based exercises [450]
Principal Investigator: Thad Starner, PhD
Study Description: The purpose of the project is to examine the effectiveness of rehabilitation centered gaming devices as a complement to traditional therapy methodologies. The goal is to create a stand-alone product that can be used both within a home setting as well as in a rehabilitation gym. Key areas of emphasis include cost effectiveness, ease of use, and entertainment value. Development of the game requires asking manual wheelchair users to test successive iterations until the game is deemed sufficiently refined.
Contact: Email Stephen Cuzzort, MS, or call 423-667-5216.
User application of the characteristics and packaging of the BaPro hydrophilic catheter design [456]
Principal Investigator: Ismari Clesson, RN
Study Description: The primary objective of this study is to assess user appreciation of the characteristics of the hydrophilic intermittent design regarding features of the packaging; ease of handling the catheter; ease of advancing the catheter; and ease of catheter removal after insertion and drainage of urine. Each subject will be provided with fifteen (15) test catheters to be used consecutively, using their established preparation procedure, and according to their normal habits and catheterization schedule. The study is comprised of two (2) visits. Total study participation time per subject will be up to four (4) days or after use of a maximum of fifteen (15) catheters whichever comes first.
Contact: Email Ismari Clesson, RN or call 404-350-7651.
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.
Contact: Email Nell Klein, RN or call 404-367-1307.
Personalized physical activity and nutrition Intervention for overweight/obese adults with mobility disabilities (PEP-II) [491]
Principal Investigator: Mike Jones, PhD
Study Description: Physical activity and nutrition may improve health, and may help medical problems such as diabetes, high blood cholesterol, and other conditions. In addition, people who are overweight or obese are more likely to lose weight when dieting is combined with regular physical activity. This study will investigate different ways of increasing physical activity and/or providing nutrition among people with mobility disabilities.
Contact: Email Ismari Clesson, RN or call 404-350-7651.
Recovery of Microbial Contaminates From Wheelchair Cushions and Covers [503]
Principal Investigator: Michelle E. Nemeth, PT
Study Description: The purpose of this study is to obtain surface cultures of various common cushion types/material types to investigate whether certain bacteria, molds and fungi are present. These organisms are thought to influence how cushion materials and covers degrade over time. This study will also look at identifying the effect these organisms have on the product’s functional life.
Contact: Email Michelle Nemeth, PT or call 404-350-7661.
i-Step Long-Leg Orthosis: Study Protocol 1 (Orthosis Validation) [510]
Primary Investigator: David Apple, MD
Study Description: This study will test the performance of a new power-assisted bracing system called the “i-step” system. This is a pilot study with one participant with a complete SCI at a level of T10-12.
Contact: Email Rachel Betzler, MA or call 404-367-1305.
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