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Amputation clinical trials

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NCT ID: NCT03517774 Completed - Amputation Clinical Trials

Improving Prosthetic Care for Patients With a Lower Limb Amputation

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Adults with lower limb amputation undergo rehabilitation in order to learn how to effectively use a lower limb prosthesis. Unfortunately, the process of being fitted a prosthesis can be delayed due to resource constraints and manufacturing times, which delays the rehabilitation process and puts patients at higher risk for functional decline. Preliminary work by our team have shown that our 3D printing system, 3DPrintAbility Devices by NIA (http://niatech.org/), perform at the same level of efficacy as traditionally manufactured prosthetics, which suggests that a digital manufacturing tool-chain is a viable alternative and may be desirable given the time savings involved. In order to lead to improved processes related to prosthesis fitting for adult transtibial amputees, we want to assess the feasibility and acceptability of using 3DPrintAbility sockets in this population. Specifically, we want to determine if: 1) the 3D printing of transtibial prosthetic sockets can provide better quality prosthetic care in regards to cost, timeliness, and accessibility; 2) 3D printed sockets are equivalent in quality to standard thermoplastic preparatory sockets in regards to safety, fit, durability and comfort; and 3) whether a 3D scanning, design and printing process can be integrated into the workflow of current rehab centres. If successful, the findings from this work can provide an innovative approach for facilitating the fitting of a socket for adults with amputation might provide significant savings to the healthcare system by making the process more efficient while optimizing clinical outcomes by allowing patients to begin their rehabilitation sooner

NCT ID: NCT03484429 Completed - Chronic Pain Clinical Trials

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

NCT ID: NCT03433300 Completed - Amputation Clinical Trials

Microprocessor Knees in Early Rehabilitation

Start date: April 13, 2018
Phase: N/A
Study type: Interventional

High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury. The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.

NCT ID: NCT03411148 Completed - Physical Activity Clinical Trials

Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Start date: April 5, 2018
Phase: N/A
Study type: Interventional

Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.

NCT ID: NCT03390153 Completed - Amputation Clinical Trials

Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees

Start date: April 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo making our prosthetic system a more comfortable experience for the prosthetic user.

NCT ID: NCT03389334 Completed - Amputation Clinical Trials

Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees

Start date: March 29, 2018
Phase: N/A
Study type: Interventional

The purpose of this graduate research study is to explore the therapeutic benefits of Myofascial Release massage on lower limb amputees with pain levels, range of motion, and muscle strength.

NCT ID: NCT03350061 Completed - Amputation Clinical Trials

Prosthesis With Sensations

Start date: November 12, 2017
Phase: N/A
Study type: Interventional

Lower limb amputees suffer complete lack of sensory feedback of current available prostheses, which excludes the central nervous system from the correct sensory-motor integration. It causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive burden, and phantom limb pain occurrence. Investigators will provide amputees with a prosthesis restoring sensory feedback and will assess its benefits on the users.

NCT ID: NCT03329326 Completed - Amputation Clinical Trials

Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome

Start date: November 1, 2017
Phase:
Study type: Observational

Background and rational: A large number of instruments exists to assess upper limb prosthetic function. However, they differ substantially in terms of psychometric properties and content. Furthermore, there is no "gold standard" and nearly every single center uses a unique set of instruments. This fact prevents the linking of the commonly small (due to the limited number of patients in each center) data sets of different centers and makes comparisons between different fittings or treatment protocols difficult. To generate accepted evidence, we need large data sets with similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in the recent years, the need to evaluate the impact of this intervention on daily life, including productivity, self-care and leisure becomes increasingly relevant. Moreover, self-reported instruments and observation-based instruments exist, but there is a lack of data if, for example, the self-reported instrument (which is easier and less health-professional's-time-consuming to perform) could "replace" a performance or observation-based instrument. Therefore, the aim of this study is to determine psychometric properties of the existing instruments (SHAP, DASH, SF-36 and ACMC) in a large international data set, to explore possible linkage between self-reported and performance or observation-based instruments and to develop state-of-the art recommendations/points to consider on how to assess functioning in prosthetic care.

NCT ID: NCT03316248 Completed - Amputation Clinical Trials

The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation

Start date: January 25, 2017
Phase: N/A
Study type: Interventional

This study was conducted to examine the effect of visual feedback on function, stability and quality of life in transtibial amputees. A total of 24 subjects who had unilateral transtibial amputations, used prosthesis with total surface bearing socket (TSB) for at least 1 year and volunteered to participate in the study were included. Before and after Treatment subjects were evaluated with "LASAR Posture" for prosthetic weight bearing (PWB), "Berg Balance Scale (BBS)" and "Timed Up& Go Test (TUG)" for balance and functional mobility, "2-Minute-Walk-Test (2MWT)" for physical performance, "Satisfaction with the Prosthesis Questionnaire (SATPRO)" for prosthetic pleasure and "Nottingham Health Profile (NHP)" for health- related quality of life. Participants were randomly divided into two equal groups as study and control groups. After the evaluations the same exercises; PWB exercises, balance exercises, anteroposterior and lateral weight shifting, obstacle course, walking on different grounds were applied to the the study group with visual feedback methods and control group.

NCT ID: NCT03161327 Completed - Hypertension Clinical Trials

Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease

Start date: July 15, 2017
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden, currently estimated to be greater than cancer and heart disease. Older age (> 65 years), smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known to have increased morbidity and mortality.Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative Services Task Force as an affordable and effective screening tool for evaluating PAD risk. QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital device that is used as a screening tool to measure ABI of patients at risk of PAD. This single center prospective clinical trial will evaluate the sensitivity and specificity of digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital ABI in detecting PAD.