23 Clinical Trials for Various Conditions
Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members. Aim 2: Compare the validated domains, such as functional, quality of life and pain scores, from the preoperative baseline to follow-up visits to determine if persons with transtibial amputations treated with OPRA osseointegrated prostheses demonstrate statistically significant and clinically relevant improvements. Aim 3: Compare physical performance measures preoperatively to follow-up visits for persons with transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant improvements. Aim 4: Quantify the biomechanical loading and bone quality changes that are directly associated with patient reported outcomes for persons with transtibial amputations treated with OPRA osseointegration. Aim 5: Compare outcome measures between persons with traditional socket prostheses (patients as self-controls) and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI. Subject Population: Male and female military health care beneficiaries age 22 to 65 years old presenting with a Transtibial limb loss. Study Design: This is a 4-year, prospective cohort FDA pivotal study involving off-label use of the OPRA OI implant in persons with transtibial amputation. Procedures: SURGICAL PROCEDURES: Surgery Stage I: The distal part of the tibia is exposed, preferably using existing incisions, to produce an appropriate fasciocutaneous flap. By the use of fluoroscopy and guiding devices the correct position of the fixture in the medullary canal is found. The canal is reamed step by step to a proper diameter to facilitate insertion of the implant. If the bone quality is poor, as determined by the operating surgeon, autologous bone graft from the iliac crest and/or the medullary canal is used. The fixture is then implanted into the intramedullary canal. Careful surgical technique is essential not to damage the tissue and to achieve osseointegration. A central screw, healing cylinder, and healing bolt are inserted. A myodesis is performed, and the wound is closed using suture. The sutures are removed 2-3 weeks postoperatively. When the skin is completely healed the Patient's conventional socket prosthesis could, in some instances, be used. Surgery Stage II (3-5 months after Stage I): The tibia is exposed via the incision from the Stage I-Surgery. The healing cylinder is removed and the tissues are trimmed in a way that the distal end of the bone protrudes a few millimeters. The skin will be attached directly to it. The endosteal canal is reamed to facilitate placement of the abutment. The skin in the abutment area is then trimmed to a diameter equal to the protruding end of the tibia. This is done to remove the subcutaneous fat and facilitate healing of the dermal layer to the distal end of the bone. The subcutaneous tissue is affixed to the periosteum using absorbable suture to prevent skin movement. A 8mm punch biopsy tool is used to create a circular hole in the skin precisely over the residual tibial canal. The remaining portion of the fasciocutaneous flap is sutured into position. A bolster dressing is placed and routine postoperative wound care is performed by daily dressing changes. Sutures are removed 2-3 weeks postoperatively. CLINICAL PROCEDURES A pre-study visit will be conducted up to 6 months prior to Surgery Stage I. Postoperative visits will occur 2-3 weeks after each surgery. Additional follow-up visits will occur 6, 12, 24, 36, 48 and 60 months post-Surgery Stage II. It is standard of care to follow patients postoperatively from time to time to ensure the wound(s) is /are healing, surveil for complications, and ensure rehabilitation is progressing. That said, the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol. Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical status/bone healing. RESEARCH PROCEDURES Timepoints: Baseline, Post-Op Stage II, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months The patients will be assessed before and after the surgery regularly. Both performance and safety data will be recorded on specially designed electronic Case Report Forms (eCRFs). Clinical and radiological assessments are performed preoperatively (in connection with the surgical procedures.
The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence. There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA. Participants will be asked to: * come to 1 hour dance classes, once per week, for 8 weeks. * do mobility tests before and after the program * complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks.
The purpose of this graduate student research study is to test that a specifically designed and novel robotic prosthetic leg (RPL) is feasible, safe and improves symmetry, efficiency, and metabolic function during sit-to-stand and stand-to-sit transitions as compared to the subject's prescribed device, and as compared to no device at all.
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a larger spectrum of patient populations (K2-K4), as well as testing additional Power Knees currently in development that are expected to become commercialized in the near future. The investigators intend to use this Level 2 trial data to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with MPKs is needed to allow for improved clinical decision making and clinical outcomes.
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are: * Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? * Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs? Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.
In this clinical research study the investigators will test the efficacy of an innovative, non-invasive methodology to reduce mortality and lower limb loss among high-risk medically-underserved patients with cardiovascular disease in North Philadelphia. Patients with cardiovascular disease and recent lower limb amputation will be treated with an intermittent compression device on the remaining lower limb to prevent dual amputation. The study hypothesis is that the study intervention will protect against further lower limb-loss/death and reduce cardiovascular mortality in these patients (one year effect against limb-loss/death). This study may result in better secondary prevention strategies for disadvantaged urban populations as well as the general population.
Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.
The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis. The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation. The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees.
The purpose of this study is to investigate the relationship between thigh strength and walking ability and assess if using a blood pressure cuff on the leg improves strength and walking performance.
The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase knee extension strength, increase volume of the residual limb and decrease chronic and phantom pain.
The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is investigating prosthesis fit, alignment and condition of the residual limb. As there are no validated measures of fit and alignment (factors known to impact comfort, function and performance among amputees) the TAOS study includes a provision in the protocol for acquisition of photographs, video and radiographs in order to help develop uniform assessments of the residual limb. The goal of the ProFit study is to validate and refine the prosthetic assessment tool (ProFit) that was developed by an expert panel of certified orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a measurement scientist and a biomedical engineer from the BADER consortium.
The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral limb through prosthetic ambulation. If specialized prosthetic gait training and proper use of the appropriate prosthetic foot can decrease forces on the intact limb, the long term health and quality of life of veterans with amputations could be substantially improved. We will address two key questions: Key Question 1: After receiving specialized gait training and a new prosthetic socket, will subjects demonstrate differences in gait symmetry and external mechanical work between the bionic and conventional prosthetic feet, while performing various functional activities. Key Question 2: Can external mechanical work be used as a clinically friendly measure to differentiate between prosthetic feet?
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking speed is likely influenced by elevated metabolic energy, but the underlying reason for slower preferred walking speeds is not fully understood. Unilateral amputees exhibit highly asymmetrical gait patterns that likely require more metabolic energy and impair functional mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to reduce metabolic energy would be especially useful for rehabilitation in older, ill individuals with reduced exercise capacities and could literally restore walking ability in people that are currently non-ambulatory. Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed, and improved gait symmetry during walking than amputees wearing a conventional prosthesis and will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during walking as age, gender, height, and weight matched non-amputees.
The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.