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Amputation clinical trials

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NCT ID: NCT05601869 Recruiting - Amputation Clinical Trials

Impact of Improving Footwear Options

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

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.

NCT ID: NCT05597696 Completed - Amputation Clinical Trials

Sitting Balance in Lower Limb Amputees

Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

NCT ID: NCT05595291 Not yet recruiting - Amputation Clinical Trials

Walking Characteristics of Patients With Amputation

Start date: February 5, 2023
Phase:
Study type: Observational

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

NCT ID: NCT05569967 Recruiting - Amputation Clinical Trials

COMPARISON OF THE EFFECTS OF TELEREHABILITATION AND FACE-TO-FACE SPINAL STABILIZATION TRAININGS ON GAIT BIOMECHANICS, BALANCE AND JOINT POSITION SENSE IN TRANSTIBIAL AMPUTEES: A RANDOMIZED CONTROLLED, SINGLE BLIND STUDY

Start date: August 25, 2022
Phase: N/A
Study type: Interventional

After transtibial amputations, biomechanical changes in the trunk, pelvis, and lumbar region cause asymmetrical strength and core muscle activation on the amputated side, which negatively affects the gait biomechanics of individuals. However, routine treatment programs do not use treatment approaches based on the core region. This study will focus on the effects of telerehabilitation and face-to-face spinal stabilization exercise training on gait, balance, joint position sense, core muscle function, and perceived mobility in transtibial amputees, after treatment, and after long-term follow-up.

NCT ID: NCT05560061 Recruiting - Amputation Clinical Trials

An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation

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

To attain high levels of mobility, people with lower limb amputation must build both the skill and the confidence to rely on their prosthesis in the environments that they will encounter in daily life. The purpose of this research is to determine whether practicing walking on an uneven terrain surface, specifically designed to present a modest, manageable disturbance to walking, can improve balance, locomotor flexibility (i.e. the ability to adapt walking to different walking contexts) and balance confidence, to a greater extent than walking on level ground alone. This preliminary study aims to determine whether uneven terrain walking is feasible and acceptable in the target population, and also to establish preliminary efficacy.

NCT ID: NCT05551988 Completed - Diabetic Foot Ulcer Clinical Trials

Predictors of Foot Amputation in Diabetic Foot Ulcers

Start date: June 1, 2021
Phase:
Study type: Observational

Diabetes affects 463 million population of the world. Diabetic foot is one of the complications of uncontrolled diabetes which can lead to amputation in 5- 24% of non-healing diabetic foot ulcers. Every 30 seconds a lower extremity is amputated in the world due to diabetes. This is a retrospective study conducted in Balochistan, Pakistan. In this study investigators explored the risk factor of amputation in diabetic patients. Baseline characteristics, clinical profile, and lab tests were retrieved retrospectively and presented in the forms of tables. Investigators compared the categorical variables in amputees vs non-amputees and analyzed associated risk factors of amputation.

NCT ID: NCT05550623 Recruiting - Amputation Clinical Trials

Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

Lower extremity amputation patients represent a frail group of patients with extensive comorbidity. The most common indication of amputation is ischemia, infection and concomitant ischemic pain due to underlying chronic disease, especially arteriosclerosis and diabetes. Prolonged general anesthesia and surgery as well as increased blood loss may result in impaired patient safety. Previous studies have shown total blood loss approx. 1000 mL in transfemoral amputations (TFA). Substantial blood loss during surgery increases the risk of anemic complications and death for this already weakened patient group. The aim of this randomized controlled trial is to improve patient safety by exploring the possibility of a more precautious surgical procedure for TFA. Hence, investigating the total blood loss and secondary differences in complications after TFA between patients operated with use of pneumatic tourniquet versus no tourniquet. Total blood loss is calculated via Nadlers approach. From a pilot series, sample size was calculated to 124, allocated 1:1 in two groups of 62 participants, to ensure detection of at least 200 mL difference in total blood loss. The hypothesis is that use of tourniquet will decrease the total blood loss, the amount of blood transfusions, time of surgery and complications related to postoperative anemia without a higher rate of adverse events. The secondary and explorative outcomes are blood transfusions, intraoperative blood loss, length of stay, time of surgery, risk of readmission, risk of re-operation, risk of mortality, complications during admission, quality of life (QoL), prosthesis use and the prosthesis-specific survey Prothesis Evaluation Questionnaire (PEQ). QoL is measured with the validated questionnaire EQ-5D-5L preoperatively, and at 3, 6, and 12 months postoperatively. The possibility to enhance patient safety is highly relevant, and this trial will aid in establishing evidence-based guidelines for TFA surgery.

NCT ID: NCT05548322 Not yet recruiting - Aging Clinical Trials

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

TACTHUM
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05542901 Completed - Amputation Clinical Trials

Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

This study evaluated the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to diabetic polyneuropathy. Study group consisted of 16 subjects with unilateral transtibial amputation due to diabetic polyneuropathy and control group consisted of 16 subjects with unilateral transtibial amputation due to traumatic reasons.

NCT ID: NCT05537792 Completed - Amputation Clinical Trials

Intent Recognition for Prosthesis Control

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

This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.