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Amputation Stump clinical trials

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NCT ID: NCT06258343 Recruiting - Amputation Clinical Trials

Extremity Thermographic Values in Individuals With Transtibial Amputation

Start date: February 20, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare thermographic values in the knee region of the healthy extremity and the amputated extremity and learn about the relationship between thermographic value and pain in the knee region of the amputated extremity. The main questions it aims to answer are: 1. Do thermal values in the knee region of the amputated extremity and the intact extremity differ in individuals with transtibial amputation? 2. Is there a relationship between the pain felt in the knee region of the amputated limb and the difference in thermal values between the extremities in individuals with transtibial amputation?

NCT ID: NCT06255288 Recruiting - Venous Leg Ulcer Clinical Trials

Time to Heal (Wound, Healing, Dialogue, Nutrition)

SNAK
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.

NCT ID: NCT05247827 Completed - Amputation Clinical Trials

The Effects of Targeted Phantom Motor Execution on Phantom Limb Control

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Lower limb amputations account for more than 85% of all amputations. In Canada, it has been reported that transtibial amputation (TTA) is the most common level of amputation. Many people with limb amputation have awareness and feel that their missing limb still exists (phantom limb), with perceptions of sensation or pain, and the ability to move the limb with or without intention. Phantom limb sensation (PLS) is defined as all non-painful somatic sensations (e.g. sense of the limb position, touch, pressure, warmth or cold, or movement) in the missing part of the limb. The incidence of PLS is about 60% in adults after 17 months. In addition to PLS, 60-70% of people with amputation experience phantom limb pain (PLP), an intense chronic pain perception in their phantom limb, in the first year after amputation. Although PLP is well known to decrease the quality of life and lessen function, little is known about PLS and phantom limb control (PLC), the ability to intentionally move or control movements of the phantom limb. Enhancing PLS and PLC especially in the immediate months after amputation, could decrease painful perception, facilitate prosthetic control, and improve the function of people with amputations. Keeping this therapeutic and rehabilitative significance in mind, it is hypothesized that a targeted program of phantom motor execution, designed to address phantom limb awareness (PLA), the general knowledge of the presence or existence of the missing limb as one's own, could be associated with improving PLC in people with TTA. Furthermore, prosthetic embodiment, the sense that the prosthesis is accepted as a part of the body with the same functional abilities, may play a role in PLC. Investigating the association of PLC, as one of the phantom phenomena (i.e. PLA, PLS, PLP, and PLC), with surgical, clinical, and demographic characteristics of people with TTA will provide better insight into how phantom phenomena develop. The association of PLC with physical function has significant clinical importance that has never been investigated in people with TTA.

NCT ID: NCT05124873 Completed - Amputation Clinical Trials

Moisture Management Liner At-Home Evaluation

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

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 nonbreathable and non-thermally conductive materials that can create a warm and ultimately moist environment. The investigators have developed a silicone liner approach to passively conduct heat from the skin using thermally conductive elastomers. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.

NCT ID: NCT04709367 Completed - Amputation Stump Clinical Trials

Characterization of Residual Limb Volume Changes in Transfemoral Amputees

Start date: May 11, 2018
Phase:
Study type: Observational

This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.

NCT ID: NCT04494555 Recruiting - Amputation Stump Clinical Trials

Do Adaptable Sockets Improve Military Performance?

Start date: November 4, 2020
Phase: N/A
Study type: Interventional

This is a repeated measures prospective study and is no greater than a minimal risk study. All study procedures will be conducted at the Center for the Intrepid (CFI) through collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Data collected at the CFI will be coded, compiled, and shared with the University of Washington investigators.The objective of the research is to test if microprocessor-adjusting sockets improve Service member performance in Military specific activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets users adjust themselves), and (b) static (traditional) sockets. Investigators also test if microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if self-reported outcomes are more favorable than for user-operated or static sockets. The hypotheses to be tested include: During intense Military specific tasks, compared to the user-adjusted socket and the static socket, the microprocessor-adjusting socket will: 1. minimize translational movement between the residual limb and the prosthetic socket; 2. maintain residual limb fluid volume; and 3. maximize prosthetic socket comfort. When using the microprocessor-adjusting socket compared to the user-adjusted socket and the static socket, participants will: 1. cover the greatest distance during a simulated combat patrol; 2. perform all high intensity Military specific tasks with less pain; 3. perform a simulated combat patrol nearer to uninjured levels of performance; and 4. rank usability at a level similar to the static socket. The specific aims are to: 1. Fabricate microprocessor-adjusting sockets specific for Service members and Veterans with goals of returning to high-level physical activities 2. Evaluate Military task performance in Service members with transtibial amputation using "Readiness Assessments," while wearing three socket configurations: microprocessor-adjusting, user-adjusting, and static - Simulated combat patrol in a Virtual Realty Environment - Military version of a Functional Capacity Evaluation 3. Characterize user preference and usability of different socket configurations

NCT ID: NCT04484805 Completed - Amputation Clinical Trials

Socket Cooling Effectiveness Take Home Study

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03948087 Not yet recruiting - Edema Leg Clinical Trials

Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation

EMPAR
Start date: May 2019
Phase: N/A
Study type: Interventional

Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation.

NCT ID: NCT03544853 Completed - Amputation Stump Clinical Trials

Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets

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

The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The main hypothesis of this proposal is that the novel quantitative interface is equivalent to, or better than, a conventional interface in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire.

NCT ID: NCT02436148 Completed - Amputation Stump Clinical Trials

Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire

Start date: March 2015
Phase: N/A
Study type: Observational [Patient Registry]

The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.