Clinical Research Participation

The Amputee Coalition - the leading national organization for people with limb loss - recognizes the value of clinical research in identifying needs, evaluating care, and developing new technologies for people with limb loss.

PDF format requires Acrobat Reader from Adobe. Click here to download the policy that describes the application process through which Amputee Coalition may agree to participate in the recruitment of subjects for research.

If you are a researcher and wish to submit an application for Amputee Coalition’s participation in recruitment as described in the policy, please send an e-mail notification to research@amputee-coalition.org.

Projects Approved for Amputee Coalition Participation

The project(s) on this page are those who have completed all the necessary documentation to assure that the research project’s human subject protocols are approved through a recognized institution’s Institutional Review Board and has provided a statement that there are no commercial conflicts of interest. This listing does not imply endorsement of the Amputee Coalition. Research projects are listed as a service to researchers and the limb loss community. The Amputee Coalition is not responsible for the conduct of the researchers. The sponsoring institution assumes responsibility for researcher conduct.

Participants Needed for Peripheral Arterial Disease (PAD) Clinical Trial

Biomet® Biologics is seeking volunteers to participate in a clinical trial to study the safety and effectiveness of a investigational treatment to prevent or delay amputation in patients with a severe form of PAD known as Critical Limb Ischemia (CLI).

Participants will receive either the investigational treatment or a placebo treatment for their condition and attend office visits at weeks 6, 12, 24, 36 and 52, with phone calls occurring at weeks 3, 9, 18, 30 and 44.

The cost of the procedure and follow up clinic visits are covered by the study sponsor. Compensation may be provided for travel-related expenses associated with follow up visits.

For more information about this study, please visit www.padstudy.org or, if you prefer to speak to a live operator, please call 1-877-788-3972.

WORK ON YOUR WALKING AND BALANCE THROUGH EXERCISE

You are invited to participate in a cost free research project titled:

“The Effects of Gait Training with Visual Feedback on Motor Outcomes in People with Lower Limb Amputations”

You are qualified to participate if you meet the following criteria:

  • 18-65 years old
  • Have your own prosthetic
  • Been on current prosthetic for at least 3 months
  • Ability to walk at self selected pace independently for 15+ minutes
  • Ability to follow test and training procedures

Receive the following

  • 3-D Gait Assessment
  • Computerized Balance Assessment
  • 5-Week Exercise Program
    -OR-
    One-time bout of exercise (30 minute treadmill walk and warm up and cool down for a total of about 1 hour of training).
    No 5 week commitment needed!

Location & time:

  • California State University Northridge
  • 3x weekly at selected time

For more information, please contact:
Leora Gabay, Graduate Researcher
LeoraGabay@gmail.com / (818) 915-7577
Center of Achievement through Adapted Physical Activity
Department of Kinesiology, California State University Northridge

Do you have amputations in both your legs and use prostheses 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. Last year, we tested PLUS with people who had amputations in one leg. Now, we want to make sure PLUS asks meaningful questions for people with amputation in both legs.

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

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 both of your legs
  • You have no other amputations (for example, in your arms)
  • Your amputations are below your hip and at or above your ankle
  • Your amputation was the result of either an accident, cancer (tumor), or dysvascular complications (diabetes or other conditions related to blood flow)
  • You own and regularly use lower limb prostheses (artificial legs)
  • 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.

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

Volunteers needed for a study on balance and falling

Researchers at Walter Reed National Military Medical Center and Virginia Tech are conducting a telephone survey among lower limb amputees to better understand the causes and circumstances of falls.

We are looking for volunteers who:

  • are between the ages of 18 and 50
  • have an amputation in only one leg

If you have any questions or are willing to participate, please email your first name and phone number to falling.study@gmail.com or call 1-877-495-1556.

Effective and Reliable Peripheral Nerve Recordings

The purpose of this study is to gather knowledge about the functioning of the nerves in the residual upper arm of amputees and to determine if it is possible to record useful information from those nerves over an extended timeframe (6 months). If successful, this study will form the foundation for future work directed at developing systems that use these neural signals to provide amputees with the ability to control advanced prosthetic limbs easily and effectively. This research is being conducted by researchers at the Adaptive Neural System laboratory at Florida International University.

To learn more about participating in this study, see the researcher's recruitment brochure.

To learn more about the Adaptive Neural Systems (ANS) laboratory at Florida International University, please visit their website – http://ans.fiu.edu.

Participants Needed for Chronic Postamputation Pain Study

  • We are looking for volunteers to take part in a study of an electric nerve block application for patients suffering from chronic postamputation pain.
  • Your participation would involve office visit sessions, each of which is approximately 60 minutes for the purpose of interviews and completion of questionnaires.
  • In appreciation for your time, you will receive $50 per office visit.
  • There will be no cost to you for taking part in this research study. The clinic visits, tests and surgical procedures that are done as part of the research study will be provided at no cost.
  • For more information about this study, or to volunteer for this study, please contact by phone (937- 434-2226) or email: ohiopainclinic@gmail.com :

Dr. Amol Soin, The Ohio Pain Clinic
8934 Kingsridge Dr., Suite 140
Centerville, OH 45458.
Phone: 937-434-2226
ohiopainclinic.com

This study has been reviewed by, and received ethics clearance through the Copernicus Group Institutional Review Board

Evaluating Investigational Robotic Prostheses for Bilateral Transfemoral Amputees

Researchers at Vanderbilt University are developing a new kind of robotic prosthesis. Previously, this prosthesis has been tested on unilateral, transfemoral amputees with a high degree of success. This study intends to investigate the use of a pair of these robotic legs to help bilateral, transfemoral amputees improve their gait. These prostheses are investigational, meaning that they are not approved by the Food and Drug Administration (FDA). Potential advantages of these prostheses include improved gait, decreased energy use, decreased socket forces and the ability to climb stairs and steep slopes.

If you participate in the study, you will meet with researchers at Vanderbilt for a series of development and training sessions. The length of these sessions will typically be 3 to 4 hours, and the number of sessions will depend both upon your availability and the direction of the development. Activities you may be asked to perform include standing, sitting, walking and stair climbing/descending. Because the prostheses are investigational and not approved by the FDA, you will not be permitted to take the devices home with you. You will be compensated at a rate of $30/hour for your time.

In order to be considered for inclusion in this study, you must:

  • Have bilateral, transfemoral (above-knee) amputations
  • Be more than 6 months post independent ambulation (using prostheses)
  • Be between 18 and 65 years of age
  • Weigh less than 90 kg (200 lbs)
  • Have no other abnormal vestibular, ocular or somatosensory conditions.

This study has been approved by the Vanderbilt University Institutional Review Board.

If you feel that you are willing and qualified for this study, please contact graduate research assistant Brian Lawson at brian.e.lawson@Vanderbilt.edu to request a meeting to go over the details of the study and be screened.

The principal investigator of this study is Dr. Michael Goldfarb, PhD (michael.goldfarb@Vanderbilt.edu). Dr. Goldfarb runs the Center for Intelligent Mechatronics in the mechanical engineering department of Vanderbilt University.

NIU Study: Amputation, Prosthesis Use, and Phantom Limb Sensation/Pain

This research study, conducted at Northern Illinois University, investigates the effects of overall health, prosthesis use, post-operative training, residual limb pain and phantom limb sensation/pain on the rehabilitation of amputees. This research seeks to understand the factors associated with successful rehabilitation and to identify obstacles or challenges.

There is no cost to participate in this study, and research participants will be compensated $50 for their time. Participation includes a 60-90-minute tape-recorded, telephone interview. At any time, participants may ask questions, refuse to answer a question, or stop the interview. You qualify to participate in the study even if you are currently in the process of rehabilitation.

This project has been approved by the Northern Illinois Office of Research Compliance Institutional Review Board.

If you would like more information or are interested in participating, please contact graduate research assistant Kimberly Leifker at 815/298.9255 or at Kleifker@gmail.com.

The principal investigator of this study is Dr. Cassandra S. Crawford, PhD, of Northern Illinois University, Department of Sociology (ccrawford@niu.edu).

NIH Research Study: Phantom Limb Pain, Mirror Therapy and the Brain

This research study at the National Institute of Mental Health investigates brain activity and pain in amputees. Researchers are investigating mirror therapy, a treatment that may be helpful in reducing pain in the missing limb. During mirror therapy, the amputee views their moving intact limb in a mirror, making it seem as if the missing limb is moving.

In this study, researchers seek to understand how mirror therapy works, what parts of the brain are affected by the amputation, and how mirror therapy reverses those changes. There is no cost to participate in this study, and research participants are compensated for their time. Participation includes: One to four, three-hour outpatient visits to the NIH Clinical Center in Bethesda, Maryland, Brain imaging (MRI), behavioral tests, questionnaires and mirror therapy training.

You may qualify for participation if you are between the ages of 18-75; an amputee (with or without phantom limb pain); do not have any metal or shrapnel in your body; do not suffer from diabetes; and without multiple amputations.

Call: Emily Bilger, 301/402-7511
Email: NIMHAmputeeStudy@mail.nih.gov
TTY: 866/411-1010
patientinfo.nimh.nih.gov/PhantomLimbPain.aspx

Cortical Organization in Allogenic Hand Transplants and Heterotopic Hand Replants

Database of Amputee Patients and Controls
Researchers at the University of Missouri in Columbia MO are conducting a series of studies to investigate the effects of limb loss or absence on areas of the brain that control movements and feel sensations. This study may involve behavioral testing of hand function, functional (fMRI) and structural (sMRI) magnetic resonance imaging. In addition, participants will have the option to take part in the complementary procedures of single‐ and paired-pulse transcranial magnetic stimulation (TMS).

Potential participants must be:

  • 18-70 years old
  • In good health, with no history of neurological or psychiatric illness
  • Living in Missouri or neighboring states (MO, KS, NE, IA, IL, KY, TN, AR, OK)

For the current study, we are seeking volunteers with an upper extremity amputation. Participants will be compensated $30/hour for their time and reimbursed for all travel expenses.

Database of Limb Loss and Congenital Absence
Individuals with any limb loss or congenital absence (one or more upper or lower limbs) who meet the above criteria are encouraged to contact us for participation in a research database. This database will allow us to contact you when we have a future study for which you may be eligible. Please contact Dr. Scott Frey to inquire about compensation for your time and reimbursement for travel expenses for participation in future studies.

For more information on either the current study or the database, please leave a message for Dr. Scott H. Frey via email: freylab@missouri.edu or by calling 573-882-3866.

Microprocessor Knee vs. Mechanical Knee: Impact on Functional Outcomes in Dysvascular Transfemoral Amputees

Do you have an above-knee amputation due to circulation problems? The Rehabilitation Technologies Lab at The Rehabilitation Institute of Chicago (RIC) is conducting a study with amputee subjects. This study is called "Microprocessor knee vs. mechanical knee: Impact on functional outcomes in dysvascular transfemoral amputees." The purpose of this study is to find out if a computer-controlled, microprocessor leg or a mechanical prosthetic leg will allow a higher level of functioning in above-knee amputee subjects.

People with above-knee amputations who participate in our study may be asked to:

  • Take a brief screening phone call (about 5 minutes) about the reasons for their amputation and general level of function. You will not be paid for this portion of the study.
  • The criteria for the study include: an above-knee amputation due to circulation problems, 6 months or more post-prosthetic fitting and limited ability to walk in your community.
  • If you meet the criteria for the study, you will come to RIC and speak with a researcher about the study and sign a consent form.
  • If you qualify for the study, it will require commitment for a year. You will receive a new, computerized, microprocessor knee for 6 months and will have to wear your current prosthesis for 6 months. We will conduct various functional tests and you will receive some physical therapy during the study. You will also be compensated for your time.

If you would like more information, or if you are interested in participating, please call Principal Investigator Dr. Arun Jayaraman, PT, PhD, at 312/238-6875 or Study Coordinator Gayatri Mathur, PT, at 312/238-3840.

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.

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.

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

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

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.

Peer Support Facts

  • Did you know that the Amputee Coalition held its first peer visitor training in1993?
  • There are over 260 amputee support groups registered with the Amputee Coalition across the nation.
  • The Amputee Coalition has trained over 1,000 certified peer visitors to meet with amputees and family members in times of need.

 

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For more information about participating in research, contact George Gondo at ggondo@amputee-coaltion.org

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