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Amputation clinical trials

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NCT ID: NCT00866112 Completed - Stroke Clinical Trials

A Randomized Exercise Trial for Wheelchair Users

Start date: May 2008
Phase: N/A
Study type: Interventional

People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.

NCT ID: NCT00840164 Recruiting - Diabetes Clinical Trials

Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes

Start date: February 2009
Phase: N/A
Study type: Observational

1. To explore the pathology of nerve, vascular, and skin in the amputated leg 2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention 3. To search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb

NCT ID: NCT00778856 Terminated - Amputation Clinical Trials

Hand Transplantation for the Reconstruction of Below the Elbow Amputations

VCA-01
Start date: September 2008
Phase: N/A
Study type: Interventional

Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung. Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue allotransplantation} is the term used to describe transplantation of multiple tissues (skin, muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several recent advances in clinical organ transplant immunosuppression and experimental limb VCA have now made it feasible to consider clinical VCA for the functional restoration of patients with loss of one or both hands. This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical Center (VAMC) and at Emory University for patients with below the elbow amputations. It will evaluate the patients' use of transplanted limb(s) in activities of daily living and compare the function of the transplanted hand to the function with their previous prosthesis. Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered from deceased donors following the guidelines of and in cooperation with the regional Organ Procurement Organization. The transplantation procedure and postoperative care will be performed using the standard technique for limb replantation. Patients will receive standard immunosuppressive regimen. Rejections will be treated in keeping with experience from the solid organ transplant experience. Graft failure will be treated with allograft amputation.

NCT ID: NCT00771862 Terminated - Amputation Clinical Trials

Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study

Start date: October 2008
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.

NCT ID: NCT00771589 Recruiting - Amputation Clinical Trials

Active Knee Prosthesis Study for Improvement of Locomotion for Above Knee Amputees

Start date: May 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a robust, low-power, stable, and light weight, active knee prosthetic device that can dramatically increase gait symmetry and walking economy of a transfemoral amputee during walking. State of the art prosthetic knees can be classified into three main classes: a) mechanically passive, b) variable-damping, and c) powered. Although the devices within each of these classes offer some advantages for above-knee amputees, their overall performance still presents some deficiencies. Artificial knees in the first two groups are predominantly damping devices, incapable of providing positive power output. Moreover, current powered prostheses are heavy and inefficient in their energy consumption, and/or they have a limited range of motion. To overcome such inadequacies, we have designed a novel prosthetic knee device with a biomimetic approach. The design of the active knee prosthesis is inspired by the antagonistic muscle anatomy of the human knee joint. This device mimics the synergistic muscle activity at the knee using a double series-elastic actuator (SEA) system that resembles the major mono-articular muscle groups that help flex and extend the knee joint. The agonist-antagonist SEA knee architecture will allow for precise force control of the knee joint, mimicking the spring-like behavior of the human knee, as well as providing adequate energy for forward progression of the body. The SEA has been previously developed and tested on legged robots. Also, the SEA has been successfully applied to the development of an actuated ankle-foot orthoses (AAFO) at MIT AI Lab. The mechanical architecture of the active knee prosthesis allows for independent engagement of flexion and extension tendon-like, series springs for the control of joint position and impedance, as well as net joint torque. Furthermore, this architecture permits a joint rotation with near zero friction, allowing the controller to take advantage of the passive dynamics of the system, thus, augmenting the overall energetic efficiency of the system.

NCT ID: NCT00768248 Terminated - Amputation Clinical Trials

Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Start date: October 2008
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine if putting local anesthetic—or numbing medication—through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.

NCT ID: NCT00667264 Completed - Amputation Clinical Trials

Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Start date: October 2008
Phase: N/A
Study type: Interventional

Research study to determine if putting local anesthetic—or numbing medication—through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.

NCT ID: NCT00663663 Completed - Multiple Sclerosis Clinical Trials

Telephone Intervention for Pain Study (TIPS)

TIPS
Start date: September 2009
Phase: N/A
Study type: Interventional

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 persons with multiple sclerosis, spinal cord injury or 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.

NCT ID: NCT00623818 Completed - Amputation Clinical Trials

Mirror Therapy for Phantom Limb Pain

Start date: March 5, 2008
Phase:
Study type: Observational

This study, conducted at the National Institutes of Health (NIH) and at Walter Reed Army Medical Center (WRAMC), will explore the phenomenon of phantom limb pain (a continued feeling of pain in an amputated limb) and will use functional magnetic resonance imaging (fMRI) to investigate the effect of mirror therapy on phantom limb pain. Right-handed people between 18 and 75 years of age who are in the WRAMC Military Amputee Research Program and healthy control subjects may be eligible for this study. Participants undergo the following procedures: Amputees - Questionnaires to assess strength of handedness and footedness and pain perception. - Mirror therapy for phantom limb pain five times a week for 4 weeks in 15-minute sessions. - MRI and fMRI scans before starting mirror therapy, after 2 weeks of therapy and after 4 weeks of therapy. MRI uses a magnetic field and radio waves to image brain tissue. The subject lies on a table that can slide in and out of the scanner (a metal cylinder). The structural MRI scan lasts about 30 minutes. For fMRI, the subject performs tasks while in the scanner in order to show changes in brain activity involved in performing those tasks. Subjects are shown pictures of feet and other body parts, are asked to move their feet, and receive tactile (touch) stimulation of the foot or other body parts. Control Subjects One group of control subjects undergoes a single fMRI procedure. A second group of control subjects undergoes the same sequence of three fMRIs over the same time period as the amputee subjects. None of the control subjects undergo mirror therapy. ...

NCT ID: NCT00499356 Completed - Diabetes Clinical Trials

Shear and Pressure Reducing Insoles for the Diabetic Foot

GlideSoft
Start date: May 2002
Phase: N/A
Study type: Interventional

We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear. Although insurance providers spend millions on diabetics’ therapeutic insoles, there is no scientific data about shear or pressure reduction. We will evaluate the optimal bonded materials from Phase I compared to the Glidesoft™ design using the same combination of viscoelastic materials. We evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month trial. The control group patient arm wore a traditional bonded insole whereas another the second arm receive the GlideSoft™. At baseline, and at the end of the 18 month trial, in-shoe gait lab and in vitro biomechanical parameters measured pressure, shear, and material properties as these changed with wear. This Phase II eighteen (18) month clinical trial evaluated the effectiveness of ShearSole™ reducing the incidence of diabetic ulcers. The overall study hypothesis was that GlideSoft™ provides significant shear reduction as compared to traditional insoles without sacrificing pressure reduction characteristics or durability.