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Amputation clinical trials

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NCT ID: NCT06293443 Recruiting - Amputation Clinical Trials

Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

NCT ID: NCT06284005 Completed - Amputation Clinical Trials

Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral Level

MOTU-ATP
Start date: July 27, 2020
Phase: N/A
Study type: Interventional

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees. The main question it aims to answer are: - Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device. - Provide an indication of the functional effectiveness of the device and its satisfaction by patients. Participants will perform: - walking tests inside parallel bars on flat and/or inclined terrain; - walking tests on treadmill; - stair climbing/descent tests.

NCT ID: NCT06275282 Recruiting - Amputation Clinical Trials

Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration. The main questions it aims to answer are: 1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery? 2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom? 3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback? Consenting participants with unilateral transfemoral amputation (TFA) will: 1. Undergo RPNI surgery and electrode implantation in the residual limb. 2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation. 3. Undergo explantation of electrodes following the conclusion of data collection.

NCT ID: NCT06259695 Active, not recruiting - Amputation Clinical Trials

Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy. Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss. The pool environment offloads body weight, which can improve comfort on a residual limb and increase confidence in activities outside of the pool. The properties of water also assist in strengthening exercises and reducing pain. Currently, most individuals do not have a prosthesis to use in the pool. Water specific prosthesis are often not covered by insurance and can be expensive. For someone that doesn't have a water specific prosthesis, they may not be able to do therapy tasks on two legs, limiting what activities or exercises can be performed. Through creating an adjustable prosthesis, it will allow persons with limb loss to have access to a water specific leg in a time efficient, cost effective, and safe manner for rehabilitation. This study involves a novel prosthesis for use in aquatic therapy. This novel design will have an adjustable circumference, residual limb length, and height, allowing a greater number of patients to use the prosthesis.

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: NCT06249594 Completed - Amputation Clinical Trials

Targeted Sensory Reinnervation (TSR) in Hand Amputation

Start date: May 18, 2022
Phase:
Study type: Observational

If a person has to have a part of their body amputated, in this case their hand, the patient then lacks information about the missing limb, which in many cases leads to pain that severely restricts their quality of life and participation in everyday life. This is usually phantom and/or neuroma pain. Phantom pain is usually caused by many different mechanisms and occurs in 80-90% of patients. Pain caused by terminal neuromas affects 13-32% of amputees and manifests itself as residual limb pain. A neuroma itself is a benign lump that can develop at the site of the defect after a nerve has been severed (neurectomy). In some cases the impairment is so severe that prosthetic tolerance, functional independence and quality of life can be severely affected. Numerous treatment options for these types of pain are far from satisfactory for many patients and remain a major challenge for both the clinician and the person affected. It is often no longer possible for the patients to pursue a profession or hobby due to the pain as well as due to the pain medication required and its possible side effects. Surgical intervention can therefore be considered for patients who do not (or no longer) respond to conservative pain treatment. In recent years, many surgical approaches have been introduced to treat or prevent post-amputee pain. One of these methods can make it possible to create an authentic feeling of the missing limb and thus reduce or eliminate phantom pain by means of targeted sensory reinnervation (TSR) of the lost body part. Sensory reinnervation means that a nerve which enables a (sensory) perception associated with a sense is "redirected" to a new area of the body and can therefore fulfil at least part of its task again. In this case, an authentic feeling of the lost body part. The aim of this retrospective data-analysis is to evaluate data from patients with hand amputation (planned surgery or caused by accident/infection..) who have undergone TSR surgery to treat or prevent phantom and neuro-pain with regard to different parameters.

NCT ID: NCT06214026 Recruiting - Amputation Clinical Trials

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility. The main study questions/goals are: 1a) To determine if frontal plane adaptation in a foot prosthesis impacts performance, comfort, activities of daily living, and community mobility in the study populations. To answer this question, we will compare a locked and unlocked version of the novel prosthesis. 1b) To determine how the unlocked investigational foot condition compares to the person's usual foot using the outcomes listed above. 2) To examine the participants' lived experience during community activities. The study will use performance tests, questionnaires, logbooks, and interviews to monitor person-centered outcomes and perceptions of personal functioning during the use of the investigational foot (locked and unlocked) compared to the person's usual foot.

NCT ID: NCT06210620 Recruiting - Amputation Clinical Trials

Pro APP Prosthetic Outcome Registry

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.

NCT ID: NCT06194838 Recruiting - Amputation Clinical Trials

Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

Start date: September 12, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06182202 Recruiting - Amputation Clinical Trials

Comparing Intact and Residual Amputated Muscle

Start date: June 17, 2022
Phase: N/A
Study type: Interventional

Lower limb amputees rely on their prosthetic to remain active and lead an independent life. In recent years, measuring residual muscle activity has been used to interpret a user's intent and thereby modulate prosthesis control. However, little knowledge is held on how residual muscle activity differs from non-amputated muscle. The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees' non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles. Such information will inform design of modern prosthesis controllers.