Clinical Research Participation

Do you use a prosthesis for walking? If so, we need your help!

Researchers at the University of Washington are developing the Prosthetic Limb Users Survey (PLUS), a tool to help prosthetists and researchers better understand the experience of using a prosthesis. We need your help to make sure PLUS asks meaningful questions about the things you can do with your prosthesis.

We need volunteers to fill out an online survey that asks about you, your health, and the things that you can do with your prosthesis.

If the list below describes you, then this study may be right for you.

• You are 18 years of age or older
• You have an amputation in one of your legs
• You have no other amputations
• The amputation is below your hip and at or above your ankle
• The amputation was the result of either an accident or dysvascular complications (diabetes or other conditions related to blood flow)
• You regularly use a lower limb prosthesis (artificial leg) to walk
• You are able to read, write, and understand English.

People who live anywhere in the United States are welcome to take this survey. If you are eligible to participate, you will receive $25 for completing the survey.

If you feel this study may be right for you and would like to know more or take this survey please go to:

www.MobilitySurvey.org

If you would like more information, you can contact a study coordinator at 1-800-504-0564 or info@mobilitysurvey.org (Please note that confidentiality of email cannot be guaranteed).

The principal investigator of this study is Brian Hafner, PhD of the University of Washington, Department of Rehabilitation Medicine. (IRB # 38227)

Assessing Non-Medical Resources Provided to Children Who Have Experienced Amputation

Children who experience amputation and their families often need extra support services because amputation is a traumatic event. This research is exploratory and is intended to assess the non-medical needs and services received by families of children experiencing amputation.

You are eligible to participate if:

• You are a parent/caregiver over the age of 18
• Your child has undergone amputation any time in the past 10 years

To participate in this study, please visit the following Web site to complete a short (15-minute) survey:

surveygizmo.com/s3/737598/Non-medical-Services-for-Caregivers-of-Children-Who-Have-Experienced-Amputation

If you would like more information, please contact Katie Eickholt at eickholt.23@buckeyemail.osu.edu or Dr. Denise Bronson at bronson.6@osu.edu or 614/292-1867.

Trunk Mechanics and Neuromuscular Control in Low Back Pain: Comparisons Between Lower-Limb Amputees and Healthy Controls

Researchers at Virginia Tech (Blacksburg, VA) are actively recruiting participants for a study investigating the role of lower-limb amputation in the development of low back pain. Recent evidence suggests that low back pain (LBP) represents a significant secondary disability among persons with lower-limb amputation. The purpose of this research is to better understand musculoskeletal injury to the lower back and how lower-limb amputation affects trunk mechanics and surrounding muscle responses.

The study involves several non-invasive and low risk biomechanical tests and movement tasks, while adhesive markers and sensors are placed on the skin around the abdomen and lower back to measure muscle activity and positions. The experiment will last approximately two hours and will be conducted in a biomechanics laboratory on the Virginia Tech campus.

To participate, you need to be:

• Over the age of 18
• An individual with an above- or below-knee amputation (≥1 year post-amputation)
• Moderately active and a regular prosthesis wearer
• No recent history (6 months) of falls or other neurologic/musculoskeletal disorders.

Participants will be compensated $50/hour for their time in the laboratory (up to $100 maximum compensation). Transportation assistance and travel reimbursement ($0.55/mile, up to 90 miles) may also be available upon request.

Experimental protocols have been approved by the Virginia Tech Institutional Review Board (IRB #11-518).

For more information, please contact Brad Hendershot at Virginia Tech at hendershot@vt.edu or by calling (610) 390-4491 (cell).

Analysis of Biofeedback as a Therapeutic Intervention for Post-Amputation Pain

Post-amputation pain (PAP) is highly prevalent in all types of amputations, and often a prominent factor in disability, yet we know very little about its pathopsychology. Our preliminary data indicate that PAP subjects usually have autonomic dysregulation in the residual limb and that thermal biofeedback with relaxation training can result in dramatic pain relief in many PAP subjects through the potential mechanism of decreasing sympathetic drive to pathologically sensitized tissue. The preponderance of recent biofeedback literature supports change in self-efficacy and locus of control as the primary therapeutic processes involved in biofeedback associated with pain relief, and it is likely that these cognitive changes account for some of the improvements seen in PAP. However, we hypothesize that enhanced self-efficacy accounts for only a portion of the improvement in pain in post-amputation subjects, and that improvement also correlates strongly and specifically with measurable physiologic changes, especially a diminution in sympathetic efferent tone. In this proposed research, we will assess the relative contribution of cognitive behavioral changes (i.e., self-efficacy) and objective physiologic changes (i.e., vasomotor tone) to decreased pain in PAP during the process of mastering thermal biofeedback, a model for quantitatively and simultaneously assessing a mind-body therapeutic interaction.

We hypothesize that thermal biofeedback and relaxation training will effectively decrease post-amputation pain through the intermediary of "mind" (cognitive, specifically self-efficacy) and "body" (physiologic, specifically decreased sympathetic discharge into an adrenergically sensitized residual limb). Self-efficacy will be shown to have a significant impact on the relationship between biofeedback and pain ratings.

For information regarding participation in this study, please contact Dr. R. Norman Harden at the Rehabilitation Institute of Chicago at nharden@ric.org.

Comparative Outcomes Assessment of the C-Leg and Genium Knee Prosthesis:
A Pilot Study

In the United States, there are more than 300,000 persons with amputation above the knee. The majority of these individuals will not attain independent ambulatory function without daily use of a knee prosthesis. Prior to 1997, microprocessor knee control technology was not available. The C-Leg was made commercially available in 1997, introducing real-time gait analysis. This led to instantaneous prosthetic reaction to acute changes in gait velocity. Such functional improvements over mechanical control have considerably advanced established features such as stumble recovery, which has been proven to reduce falls in amputees. Much evidence has substantiated efficacy of the C-Leg knee prosthesis in both household and community ambulating transfemoral amputees in several functional areas including safety, increased activity, walking velocity, improved gait biomechanics, ambulation on uneven terrain and over obstacles, and also in terms of cost efficacy. The latest knee prosthesis, the Genium knee, is engineered with advances beyond those incorporated in the C-Leg, reportedly enabling users to safely walk backwards and ascend stairs reciprocally. Because no comparative efficacy studies exist to substantiate claims of improved function, this randomized clinical trial seeks to determine if the Genium knee offers improved function and satisfaction over the C-Leg, which represents the current standard of care.

For information regarding participation in this study, please contact M. Jason Highsmith, DPT, CP at the University of South Florida at mhighsmi@health.usf.edu.

Telephone Intervention for Pain Following Amputation

Researchers in the departments of Orthopedics, Psychiatry & Behavioral Sciences, and Rehabilitation Medicine at the University of Washington are seeking study participants in a project investigating treatment for pain related to amputation.

Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit people with an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain. Subjects will participate in eight 60-minute treatment sessions performed over the telephone by one of the study’s clinicians. Subjects will also participate in telephone interviews before, during and after treatment sessions. Participation in the study will last approximately 13 months. Compensation for completion of the telephone interviews is provided.

To participate in this study, you must be at least 18 years of age, have moderate to severe chronic pain, be able to communicate over the telephone, and be able to speak, read and understand English.

For more information, please contact Telephone Intervention for Chronic Pain Study staff at 206/616-9058 or 866/928-2104 or e-mail tipstudy@u.washington.edu. Please remember that we cannot guarantee the confidentiality of any information sent by e-mail.

Electric Nerve Block Stimulation for Amputee Pain

The goal of this study is to develop a reliable, safe, nonaddictive, and nonsystemic-side-effect treatment for managing chronic pain. The specific aim of this pilot study is to obtain preliminary efficacy data of electrical nerve block for relieving intractable post-amputation pain in a small group of amputees.

The technology of electrical nerve block is based on the finding that continuous application of low-amplitude, alternating current within a relatively high-frequency range could result in a reversible conduction block in a peripheral nerve. The extensive laboratory research conducted at Case Western Reserve University, funded by the National Institutes of Health (NIH) has provided promising data in multiple animal models. The technology is ready for proceeding into clinical test.

Five amputees suffering from chronic and severe pain refractory to existing medical treatments will be enrolled. The key inclusion criterion is immediate pain relief by the injection of a local anesthetic near the target nerve during the screening process.

A nerve electrode will be implanted on the severed nerve trunk by Dr. Soin with assistance from Dr. Velasco at KHN. The lead from the electrode will be tunneled subcutaneously to an exit site and terminated on a connector. An external pulse generator will be connected to the electrode for electrical nerve block. Patients will participate in four weekly office visits and also use the device at home. Change in pain intensity and other related information will be recorded in a diary. The electrode will be removed within 30 days of implantation.

For more information about this study, or to volunteer for this study, please contact:
Dr. Amol Soin
The Ohio Pain Clinic
8934 Kingsridge Dr., Suite 140
Centerville, OH 45458
Phone: 937/434-2226
ohiopainclinic.com

Hand Transplantation Study

We are a group of researchers at Brigham and Women’s Hospital (BWH) currently enrolling eligible patients for a research study on hand transplantation. Hand transplantation is an operation in which the hand(s)/arm(s) from a compatible donor are transplanted onto the amputee. Since only about 40 people have undergone hand transplantation so far around the world, the procedure is still considered investigational. The purpose of our Hand Transplantation Study at BWH is to find out more about the outcomes of hand transplantation.

To be considered for participation in the Hand Transplantation Study at BWH, patients must have suffered amputation of their dominant hand or of both hands at a level below the shoulder, be between 18 and 60 years of age and be committed to dedicating at least 2 years towards extensive post-transplant rehabilitation. Patients interested in pursuing hand transplantation will undergo a series of screening tests at BWH to determine whether they are eligible for the procedure. Just as in organ transplant surgery, patients who undergo hand transplantation must take immunosuppressive drugs for the duration of their lives, in order to prevent rejection of the transplanted hand(s).

If you are interested in participating in this study, or you would like additional information about this study, please contact Dr. Bohdan Pomahac by phone at (617) 732-5303, or by email at bpomahac@partners.org. You may also contact Dr. Pomahac’s assistant at lquinn1@partners.org.

Neuropathic Pain Study

Participate in a National Institutes of Health (NIH) funded research study about managing phantom limb pain.

WHY PARTICIPATE

You may or may not experience reduced pain and increased physical functioning.

You may learn more about phantom limb pain.

CONTACT US FOR MORE INFORMATION

www.inflexxion.com/researchstudies
Neuropathic Pain Study Coordinator
neuropathicpain@inflexxion.com
1-800-848-3895, extension 245
Participants may receive up to $175 for completing all study requirements

Inflexxion, Inc.
320 Needham St.
Newton, MA 02464

Mirror Therapy for Phantom Limb Pain

Researchers at Oregon Health & Science University are looking for people to be part of a research study investigating the effectiveness of mirror therapy for phantom limb pain.  Phantom limb pain is pain that seems to come from the arm or leg that has been amputated.  To participate, you must be 18-75 years old with phantom limb pain following amputation of all or part of an arm or leg on one side of the body only.  We are not including people whose amputation was related to diabetes.  You do not need to live in Oregon to participate.

The study lasts for six months.  After a brief screening by telephone, we will send you a DVD that demonstrates how to do mirror therapy.  We will then schedule a telephone visit to discuss the DVD and collect some medical history. We will ask you to use mirror therapy for a short time every day.  We will send you questionnaires to fill out and mail back at the beginning of the study and four times over the six-month period.  You may continue your usual medications and treatments during the study. 

Hand Transplantation for the Reconstruction of Below Elbow Amputations

Researchers at Emory University Hospital (Atlanta, Georgia) and the Atlanta VA Medical Center are actively recruiting patients for a study evaluating Hand Transplantation as a potential therapy for the replacement of hand(s) loss. Specifically, we are seeking patients who may be interested in being considered for a hand transplant and participating in a clinical trial designed to determine whether a transplanted hand(s) can help amputees perform their activities of daily living better than an artificial limb prosthesis.

Hand transplantation, like other forms of organ transplantation, requires a major surgical procedure and drug therapy for life after the procedure to maintain the function of the transplanted hand. As such, patients will need to undergo many tests to determine whether they are appropriate for this new therapy prior to being accepted as a trial participant.

If you think that you might be interested in being considered for this study, or if you would like additional information about hand transplantation, please contact Dr. Linda Cendales at 404/727-1731; e-mail: lcendal@emory.edu or Beth Begley, RN at 404/712-1114; email: beth.begley@emoryhealthcare.org.

Additional information about this study can be found at clinicaltrials.gov, trial reference number: NCT0077885.

Study: Understanding the body movements associated with prosthetic arm use during functional task performance.

Researchers at the National Rehabilitation Hospital in Washington, DC are currently investigating the compensatory movement patterns associated with prosthetic arm use.  The study entails participants engaging in a single day 2 hour session involving 2-dimensional and 3-dimensional task performance with their prosthetic arm while compensatory movements are analyzed.  At the conclusion of the session, participants will be asked to wear a movement monitor on the prosthesis for 24 hours to look at how often the prosthetic device is used in the home environment.

Inclusion Criteria:

• Age 18 or greater
• Any individual with a below or above – elbow amputation, or shoulder disarticulation.
• Chronic stable amputation: > 6 months from amputation
• Regular prosthesis wearer: e.g., wears a prosthesis at least once per month 
• Prosthesis includes a functional (grasping) terminal device

At the completion of the study participants will receive a $25 stipend for their time and effort.

The Principal Investigator of the study is Dr. Alexander W. Dromerick of the National Rehabilitation Hospital, an entity of MedStar Health.

For more information, please contact Rahsaan J. Holley, MS, OTR, study coordinator at 202/877-1875; email: rahsaan.holley@medstar.net

Nursing Research Study

This is a research study that looks at quality of well-being and impact of events following traumatic limb loss sustained during any military training activity or in combat to include Vietnam, Korea, Iraq, and Afghanistan.

Recruitment Screening Criteria

• Have sustained one or more upper or lower limb traumatic amputation/s in combat or any military training activity;
• And it’s been at least a year since your injury…

Your participation will include filling out three questionnaires that takes about 45 minutes.  You can complete the forms electronically, by phone, fax, or in-person.   

Purpose of this study is to investigate the relationship between well-being to include mobility, and social activity and the impact of the event after a traumatic amputation. 

Time frame for recruitment is based on the need to collect data from 50 individuals who are willing to participate.

If you are interested, meet the criteria or know of an individual who may interested and want to discuss or participate in this study;

Please contact
Shelly R. Burdette-Taylor RN
PhD Doctoral Candidate

Contact me either through my:

Website: www.tayLORDhealth.com
E-mail: Shelly@tayLORDhealth.com
Phone: 858/663-4150
Office/FAX: 858/672-9148

Study: Clinical Evaluation of the DEKA Arm

Researchers at the James A. Haley Veterans Hospital, are inviting individuals with an upper limb amputation to participate in a research study to test a new prosthetic arm. This exciting new study is a result of the Defense Advanced Research Projects Agency (DARPA) "Revolutionizing Prosthetics" Program that was announced in 2005.

The purpose of the study is to test the new DEKA Arm System (socket and arm). Subjects in this study will be fit with the new DEKA Arm, and will spend time training to use it. During about 21 visits, veterans will be asked to answer questions about the use, wear and comfort of this new artificial limb. They will also be asked to perform simple tests to see how well the arm works.

Volunteers will receive compensation for each completed visit and travel reimbursement. All information remains confidential.

The study is being led by Dr. Linda Resnik of the Providence VA Medical Center. The Principal Investigator at James A. Haley Veterans Hospital is Gail Latlief. The arm is produced by DEKA Integrated Solutions Corp., an affiliate of DEKA Research & Development Corp.

For more information about this project, please call Dr. Linda Resnik at 401/273-7100 ext. 2368 or Dr. Gail Latlief at 813/972-2000 ext. 7137.

Study: Clinical Evaluation of the DEKA Arm

Researchers at the Manhattan Campus of the VA NY Harbor Healthcare System, are inviting individuals with an upper limb amputation to participate in a research study to test a new prosthetic arm. This exciting new study is a result of the Defense Advanced Research Projects Agency (DARPA) "Revolutionizing Prosthetics" Program that was announced in 2005.

The purpose of the study is to test the new DEKA Arm System (socket and arm). Subjects in this study will be fit with the new DEKA Arm, and will spend time training to use it. During about 21 visits, veterans will be asked to answer questions about the use, wear and comfort of this new artificial limb. They will also be asked to perform simple tests to see how well the arm works.

Volunteers will be paid $80 for each session they complete, and will receive compensation for travel. All information remains confidential.

The study is being led by Dr. Linda Resnik of the Providence VA Medical Center. Principal Investigator at VA NYHHS is Dr. Nicole Sasson. The arm is produced by DEKA Integrated Solutions Corp., an affiliate of DEKA Research & Development Corp.

For more information about this project, please call Dr. Linda Resnik at 401/273-7100 ext. 2368 or Dr. Nicole Sasson at 212/951-3320.

Brain Research Study:
Effects of Limb Absence on Cortical Organization

This research project, conducted at the University of Oregon's Lewis Center for Neuroimaging, involves using magnetic resonance imaging (MRI) methods to investigate brain activity during movement and sensing tasks for persons who have experienced limb loss or were born without a limb. The ultimate goal is to improve pain management and rehabilitation. Potential participants must be aged 18-65 and in good health, and have no history of psychiatric or neurological illness, diabetes, stroke, or other brain injury. Both upper and/or lower extremity amputees are eligible. Due to the use of MRI technology, participants should have no metal in the body due to accidents, surgery, electronic implants, etc.  Participants will be paid $30/hr for 5-6 hours of time, as well as travel expenses to the research lab at the University of Oregon's Lewis Center for Neuroimaging in Eugene, Oregon.  This research study continues through August 2011. If you would like to be a research participant in this project (which is funded by the Department of Defense), please contact researchers via this email address: dalderet@uoregon.edu or by calling 541/346-0337.