Clinical Research Directory

Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation

Different ways of controlling an upper-limb prosthesis can affect how easy it is to use and how helpful it is in everyday activities. One common method, called direct control, uses signals from two muscles and can make switching between movements difficult. Another clinically available option, called pattern recognition control, uses signals from several muscles to better understand the user's intended movement and may feel more natural to use. This study compares these two control methods to see how they affect function for adults with below-the-elbow limb loss.

Impact of Improving Footwear Options

Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis will be tested in this project with women Veterans with amputations to determine the impact of improving footwear options on body image and community participation.

Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation

This study aims to evaluate the relationship between evacuation time, tourniquet use, and the development of post-traumatic stress disorder (PTSD) in patients with combat-related amputations. In the context of modern warfare, prolonged evacuation times and extended tourniquet application may contribute not only to physical injury but also to psychological trauma. The study will prospectively follow patients over 18 months to identify key predictors of PTSD and to assess their interaction.

Effect of PNF-Based Upper Extremity Strengthening With Core Stabilization on Fitness in Amputee Football Players

Amputee football (AF) is a disability-specific football in which amputees can participate. This study aims to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on physical fitness parameters in amputee football players. In the study, amputee soccer players will be randomly divided into two groups training and control groups. In addition to the standard training programs in the off-season, the amputee athletes in the training group will receive PNF-based upper extremity strengthening training combined with core stabilization training by the same physiotherapist 3 days a week for 8 weeks. The amputee football players in the control group will be given upper extremity strengthening training with free weights in addition to core stabilization training 3 days a week for 8 weeks. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Initial evaluations will be made before the start of the exercise training program and secondary evaluations will be made at the end of 8 weeks. Detailed information about the participants will be obtained with the Descriptive Characteristics Information Form. Single Leg Balance Test, Berg Balance Scale and Activity Specific Balance Confidence Scale will be used to obtain information about postural control and balance strategies of the participants. Pressure Feedback Unit will be used to measure the stabilization capacity of deep spinal muscles. Trunk muscle endurance tests developed by McGill will be used to assess the level of core stability. Isokinetic muscle strength of the upper extremity muscles will be measured with the ISOMED 2000 (2017-Germany) device. Hand grip strength will be measured with Jamar Hand Dynanometer. Closed Kinetic Ring Upper Extremity Test will be used to measure the strength, anaerobic power, and closed kinetic chain stability of the upper extremity. The Distance Triple Hop Test will be used to assess the strength, speed, balance, and control ability of a lower extremity with special emphasis on the distance traveled by the lower extremity. Sprint Test will be used to measure the running performance of amputee soccer players. The data will then be analyzed and interpreted with appropriate statistical methods.

Prosthetic Socket Fit Testing System

Ensuring a well fitting prosthetic socket is a major challenge in the care of people with amputation. Poor fit causes pain, skin issues, reduced mobility, and lower satisfaction, affecting daily activity and quality of life. Current prosthetic socket fit assessment relies on prosthesis user feedback, prosthetist experience or intrusive equipment. The investigators have developed a non-invasive prototype socket fit testing system that attaches externally to the end of any prosthetic socket and uses two air cylinders to apply resistance and track motion. During testing, socket motion is mapped to a cursor on a screen. Participants perform a test where they move their leg and socket to randomly presented targets. Movement duration and accuracy provide measures of how well the socket and leg move together. This pilot study will assess feasibility and validity of the socket fit testing system performance for above-the-knee prosthesis users.

Feasibility of Neural Feedback for Lower Limb Amputees

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses

Our sense of touch is essential to explore our environment and experience life and is based on signals from receptors in the body that are sensitive to different types of stimulation. The TACTHUM projects aims to investigate the fundamental firing of mechanoreceptors in the body to various external stimuli, with an end-aim to better understand the human somatosensory system and to apply this knowledge to provide comprehensive sensory feedback in prosthetics. We have a vast system of peripheral receptors in the skin and muscles that provide us with exquisitely detailed information about our everyday interactions. When there is injury to a body part, such as in amputation, there is a significant loss of somatosensory input. Prosthetic devices have greatly developmed in the past few years, especially with the introduction of useful sensory feedback. However, there is a lot to discover both about the workings of the somatosensory system and how to recreate this to give feedback in a prosthetic device. The main objective of the TACTHUM project is to understand how to recover and apply useful somatosensory feedback in prostheses for amputees. There are a number of other sub-objectives, to: 1. Determine how tactile mechanoreceptors encode the texture of natural surfaces during passive and active exploration. 2. Investigate how our sense of touch varies with emotional state. 3. Explore what happens to our sense of touch when we explore surfaces at different temperatures. 4. Understand the origin of our perception of humidity. 5. Investigate differences in the encoding of tactile information with age. 6. Determine the perceptions generated by the stimulation of single tactile afferents. 7. Study changes in spontaneous activity and responses to tactile stimulation on the residual limb of amputees. To accomplish these objectives, we will primarily use the technique of microneurography, in vivo recordings from peripheral nerves, to gain direct information about the firing of peripheral neurons in humans. In conjunction with this, we will use a variety of mechanical and thermal stimuli to excite somatosensory fibers and register the activity of other physiological and perceptual measures. This will allow us to gain a fuller understanding of how the incoming somatosensory signals are interpreted and processed. Overall, we aim to explore how more naturalistic tactile interactions are encoded and how these can be translated to provide realistic prosthetic feedback.

TOE Study: Treatment and Gait Analysis fOllowing an Excised Lesser Toe

Summary of study The study will examine patients with Diabetes Mellitus (DM) who have had a lesser toe amputations (LTA) (toes 2nd3rd,4th or 5th). It is currently not understood how this affects the way patients walk and foot function. No previous studies have been undertaken to examine this and its potential for causing further ulceration risk. This study is a feasibility study. It is designed to see if it is possible to undertake a large, randomised trial. It will explore how participants are recruited, kept in the study and how easy it is to follow the study protocol. Aim of the study Establish the feasibility of a corresponding full scale investigation into to the effectiveness of a toe divider made from Otoform for patients with DM following an LTA. Study Design 1. Participants will be recruited from Mid Yorkshire NHS teaching Hospital. 2. Participants will be randomised to receive either standard care or an otoform toe divider. 3. Participants age, gender, medical history, medication and blood sugar levels will be recorded. 4. Vascular and neurological assessments, foot posture and toe deformities will be undertaken and recorded. 5. All participants will have pressures measured on the plantar aspects of both feet. 6. Follow up visits will be arranged every 6 weeks for12 months for all participants to monitor foot health and changes in walking pattern and pressure redistribution. 7. If an ulceration or other foot complication occurs, the participants will be removed from the study and appropriate treatment given (the rescue arm of the study).

Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation

The purpose of this research study is to see how well a new type of myoelectric prosthesis works. A myoelectric prosthesis is a robotic limb for amputees that is controlled by sensing the activity of muscles in the body above the amputation level. This study involves a medical procedure to implant the Myoelectric Implantable Recording Array (MIRA) in the residual limb. The procedure will be performed under sedation by a physician. When muscles contract, they generate an electrical signal that can be sensed by MIRA and used to control the prosthetic limb. Myoelectric prosthetic limbs normally use electrodes that are placed on the surface of the skin to control different movements. However, MIRA is implanted under the skin, which could improve the ability to control the myoelectric prosthesis. After the MIRA is implanted, training will occur to learn how to control the prosthesis using the muscles in the residual limb. The device can stay implanted for up to one year. The device will be removed (explanted) by a physician.

Amputations in Childhood and Neuropathic Pain

This observational study aims to assess the presence of neuropathic pain in children and adolescents who underwent limb amputation during childhood. The study focuses on two types of neuropathic pain: phantom limb pain and residual limb pain. It also evaluates quality of life and functional autonomy in this population and explores potential associations between neuropathic pain, autonomy, quality of life, and age at amputation. Using a mixed retrospective and prospective design, data are collected from medical records and standardized questionnaires administered during routine follow-up visits at a specialized pediatric limb anomaly center. The study seeks to improve understanding of neuropathic pain after pediatric amputation and its impact on daily functioning.

Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs

The overall goal of this project is to model human joint biomechanics over continuously-varying locomotion to enable adaptive control of powered above-knee prostheses. The central hypothesis of this project is that variable joint impedance can be parameterized by a continuous model based on measurable quantities called phase and task variables. This project will use machine learning to identify variable impedance functions from able-bodied data including joint perturbation responses across the phase/task space to bias the solution toward biological values.

Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators

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.

Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD. All eligible consenting patients will undergo daily stoma management per standard of care. Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes. Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes. Follow-up: Study participants will be followed at 1 week and 2 weeks.

Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation

Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, \~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.

Sonomyographic Upper Limb Prosthetics: A New Paradigm

The vast majority of all trauma-related amputations in the United States involve the upper limbs. Approximately half of those individuals who receive a upper extremity myoelectric prosthesis eventually abandon use of the system, primarily because of their limited functionality. Thus, there continues to be a need for a significant improvement in prosthetic control strategies. The objective of this bioengineering research program is to develop and clinically evaluate a prototype prosthetic control system that uses imaging to sense residual muscle activity, rather than electromyography. This novel approach can better distinguish between different functional compartments in the forearm muscles, and provide robust control signals that are proportional to muscle activity. This improved sensing strategy has the potential to significantly improve functionality of upper extremity prostheses, and provide dexterous intuitive control that is a significant improvement over current state of the art noninvasive control methods. This interdisciplinary project brings together investigators at George Mason University, commercial partners at Infinite Biomedical Technologies as well as clinicians at MedStar National Rehabilitation Hospital. The investigators will optimize and implement algorithms for real-time classification and control with multiple degrees of freedom (DOF) using a miniaturized ultrasound system incorporated into a prosthetic socket. The investigators will then compare control performance between and sonomyography and myoelectric control (both direct control and pattern recognition) using a virtual environment as well as for performance of tasks related to activities of daily living. The investigators have two specific aims. Specific Aim 1: Compare between sonomyography and myoelectric direct control Specific Aim 2: Compare between sonomyography and pattern recognition with velocity control The successful completion of this project will lead to the first in human evaluation of an integrated prototype that uses low-power portable imaging sensors and real-time image analysis to sense residual muscle activity for prosthetic control. In the long term, the investigators anticipate that the improvements in functionality and intuitiveness of control will increase acceptance by amputees.

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

Analgesic Amputation for Algodystrophy: Feedback From a Case Series

What is the aim of the research? The study aims to describe the time interval between amputation for post-traumatic complex regional pain syndrome (CRPS) and functional prosthetic fitting of the amputated limb, within a series of patients managed in an expert center after failure of conventional treatments, in order to improve knowledge and medical practices in this field. What data are used? The data used in this study come from your medical record. They include administrative information (age, sex, date of hospitalization, department, length of stay), medical information (diagnoses, surgical procedures, operative and consultation reports), follow-up information (functional progress, return to activities, occurrence of complications), rehabilitation and prosthetic fitting information (dates of prosthesis fitting, whether it was accepted or not, functional rehabilitation), and information from pain centers if present in the hospital medical record. These data will be pseudonymized; that is, they will be coded and will not include your first or last name. They will be processed confidentially, only by authorized members of the research team, for exclusively scientific purposes. Who will receive the data? Authorized members of the research team who carry out the analyses will have access to the study data in coordination with the scientific lead. All these individuals are bound by professional secrecy and confidentiality. The results of the analyses will be published in scientific journals or presented at conferences. They will always be reported in aggregate form, so that it will be completely impossible to identify a study participant. How is the study conducted and how is your data security ensured? A computerized file containing only the data strictly necessary for the study will be created within Brest University Hospital (CHU de Brest). Your first and last names will not appear in this file. Only authorized members of the research team will be able to access the data. Access to the database will be secured by an individual password. Analyses will always be carried out confidentially. No individual data will be extracted from the database. The results of the study will help improve current knowledge and optimize the care of patients who may experience the same medical situation as the one you have experienced. Your health data collected as part of this research will be kept and archived for a maximum of 5 years after the end of the study.

A Comparison of Myoelectric and Bionic Hands

This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction. The main questions it aims to answer are: \- Does upper extremity function differ between bionic and myoelectric hands? The main questions it aims to answer are: Does upper extremity function differ between bionic and myoelectric hands?

Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration

The specific aim of this research is to compare three clinically available liners, each intended to address problems of residual limb perspiration, with the as-prescribed liner of lower limb prosthesis user and determine their effect on stability, suspension, and comfort.

Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users

The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures, participant-reported measures, and structured interviews to create a clinical toolbox to (i) identify individuals who exhibit reduced prosthesis use (compared to expected usage levels based on K-level designation and/or participant goals of community mobility and social interaction), (ii) identify prosthetic/physical and psychological factors that limit prosthesis use, and (iii) determine the effect of targeted interventions to increase prosthesis use and facilitate achievement of participant goals. Objective sensor-based measurement of home and community activities will allow for the correlation of real-world function to in-clinic assessments and to monitor changes resulting from rehabilitation interventions in real time. Machine-learning and data mining techniques will be used to identify a subset of measures from this toolbox that sensitively and accurately reflect real-world function, enabling clinicians to predict and assess activity and provide effective interventions to optimize prosthesis use. The goal of this project, to improve overall performance with respect to activities of daily living and other real-world activities, thus addresses the Fiscal Year 2017 (FY17) Orthotics and Prosthetics Outcomes Research Program (OPORP) Focus Area of Orthotic or Prosthetic Device Function.

Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain

The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.

Impact Evaluation of Breizh Fabribus Intervention for Personalized Assistive Technology Creation or Adaptation

In France, more than 14 million individuals report severe functional limitations, and nearly 5 million struggle with essential daily activities. Traditional barriers to assistive technology-high costs, lengthy funding delays, lack of information, and poorly fitting off-the-shelf solutions-frequently lead to underuse, dissatisfaction, and environmental waste The BFB-IMPACT study evaluates the real-world effectiveness of Breizh Fabribus, a mobile workshop equipped with 3D printing and laser-cutting that produces and customizes assistive devices on site for people with disabilities in Finistère, France region. This retrospective, single-center investigation includes all service recipients from January 2024 to December 2025 and measures changes in users' ability to perform targeted activities at three months post-intervention. Secondary outcomes include user satisfaction and device utilization. Data collection occurs from October 2025 to May 2026, with analysis anticipated in June 2026 and results published in the second half of 2026.

Prosthetic Performance Enhancement Trial

The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors

Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet. Peer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living. The investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.