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Amputation clinical trials

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NCT ID: NCT05855980 Recruiting - Diabetic Foot Clinical Trials

Toe Amputations in Patients With Diabetes

PANDORAT
Start date: May 22, 2023
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

NCT ID: NCT05840601 Withdrawn - Amputation Clinical Trials

Evaluation of Dexterous Terminal Device

Start date: December 22, 2022
Phase: N/A
Study type: Interventional

Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.

NCT ID: NCT05807607 Enrolling by invitation - Amputation Clinical Trials

Study of Lower-limb Phantom Pain Syndrome Using Peripheral Nerve and Spinal Cord Stimulation

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

Brief Summary: The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord (SCS) stimulation with implantable electrodes. The researchers expect that PLP in patients with lower limb amputation will be relieved by peripheral nerve and the spinal cord stimulation. The possibility of finding EEG biomarkers for phantom pain will be explored.

NCT ID: NCT05804565 Recruiting - Diabetic Foot Clinical Trials

MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

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

Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut. For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen. Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.

NCT ID: NCT05804097 Recruiting - Diabetic Foot Ulcer Clinical Trials

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

DIONYSIUS
Start date: October 8, 2021
Phase: Phase 4
Study type: Interventional

The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is: - What is the difference is the major amputation rate between the study arms? Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.

NCT ID: NCT05798091 Recruiting - Amputation Clinical Trials

Psychosocial Transitional Group Pragmatic Trial

Start date: June 28, 2023
Phase: N/A
Study type: Interventional

People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally have poorer quality of life. To proactively address the mental health needs of this population, St. John's Rehab recruited two psychiatrists to provide mental health support to their inpatient population groups. Because there are limits to mental health resources and because group therapy facilitates patients learning from each other, the investigators plan to test an innovative psychological group therapy program designed for limb loss inpatients to address mental health challenges, and to better prepare them to integrate back into the community. Our designed psychosocial group therapy is led by a psychiatrist and an occupational therapist who create a structured process for inpatients to discuss their challenges and identify coping strategies that will help them transition back into the community. The investigators will recruit 130 inpatients with limb loss, with 65 taking part in a weekly psychosocial group therapy program and 65 receiving treatment as usual. The investigators will evaluate if anxiety and depression significantly decreases in our treatment group compared to those who received treatment as usual. The findings of this work will provide needed evidence for the clinical feasibility and utility of a rehabilitation inpatient group therapy program, which can serve as a useful model for other limb loss sites across Canada.

NCT ID: NCT05784285 Not yet recruiting - Cerebral Palsy Clinical Trials

Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities

Start date: November 2023
Phase: N/A
Study type: Interventional

Participation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional meaningful activities within the youth's natural environment. Investigators' initial results from studies in Quebec show that targeting intervention at the activity/participation level can result in improvement of impaired body functions (e.g., balance, attention, anxiety) - important components to address in rehabilitation. Investigators' team aims to continue studying the impact of participation by launching a larger more rigorous study. Investigators have partnered with major organizations providing rehabilitation services for youth as well as key community-based stakeholders including youth, clinicians, and managers, and together investigators plan to further examine whether engaging in an 8-week community-based activity individually chosen by the youth (e.g., sledge hockey, drawing, playing a musical instrument) can lead to a significant improvement in three key body functions: motor, behavioral and emotional. One hundred and fifty youth with physical disabilities living in Quebec and Ontario will participate and engage in an activity of choice. Changes in their body functions (e.g., movement, attention, mood) will be measured multiple times before, during and after engagement in the chosen activity. Findings of this study can guide clinicians, families and policy-makers to select effective approaches that not only promote participation but also facilitate additional motor and mental benefits from a single intervention. Such 'real-world' treatment approaches involving activities of choice can also increase motivation, compliance and reduce burden on the healthcare system and on the youth and families.

NCT ID: NCT05778799 Completed - Amputation Clinical Trials

Physical Activity and Sports for People With Special Needs

Start date: September 11, 2021
Phase:
Study type: Observational

Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and disability experience.

NCT ID: NCT05778474 Recruiting - Multiple Sclerosis Clinical Trials

Mechanical Determinants of Upper Limbs Oscillation During Gait

CLAPENDAS
Start date: May 27, 2020
Phase:
Study type: Observational

It is unclear why humans typically swing their arms during gait. To date, the debate on how to arm swing comes about (i.e. whether it is caused by accelerations of the shoulder girdle or muscular activity) is still going on. There needs to be consensus on whether the arm swing is actively controlled or merely passive and on why humans swing their arms during walking (i.e. what the purpose of arm swing is, if any). Suggested reasons include minimising energy consumption, optimising stability, and optimising neural control. Pathologies such as hemiplegia after stroke, Parkinson's disease, Cerebral Palsy, Spinal Cord Injury, and Multiple Sclerosis may directly affect arm swing during gait. Emerging evidence indicates that including arm movements in gait rehabilitation may be beneficial in restoring interlimb coordination and decreasing energy expenditure. This project hypothesises that the arms swing, at least at low and intermediate walking speeds, reflects the body's Center of Mass (CoM) accelerations. Arm swing may thus depend mainly upon the system's intrinsic mechanical properties (e.g., gravity and inertia). In this perspective, the CoM is seen as moving relative to the upper limbs rather than the other way around. The contribution of major lower limb joints, in terms of power injected into the body motion, will be simultaneously explored. The study aims to investigate the mechanism and functions of arm swinging during walking on a force treadmill. To simulate asymmetric walking, healthy subjects will be asked to walk with a toes-up orthosis to induce claudication and asymmetry in ankle power. In this way, it will be possible to highlight the correlation among arm swinging, ankle power, and the acceleration of the CoM in a 3D framework. In addition, subjects affected by unilateral motor impairments will be asked to walk on the force treadmill to test the experimental model and highlight significant differences in the kinematic parameters of the upper limbs. The question of whether arm swing is actively controlled or merely passive and the relationship between arm swinging and the total mechanical energy of the CoM will be faced. Asymmetric oscillations of the upper limb will be related to dynamic asymmetries of the COM motion, and of the motion of lower limbs. In addition, cause-effect relationships will be hypothesized. Finally, the dynamic correlates of upper limb oscillations will make the clinical observation an interpretable clinical sign applicable to rehabilitation medicine. Results from the present study will also foster the identification of practical rehabilitation exercises on gait asymmetries in many human nervous diseases.

NCT ID: NCT05773560 Recruiting - Rehabilitation Clinical Trials

Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation.

Start date: November 29, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation. The main questions it aims to answer are: - Does the virtual-reality-assisted rehabilitation improve the life quality of patients (i.e. lesser pain, better spirit)? - Does the virtual-reality-assisted rehabilitation improve the daily life function of the patients? Participants will received a virtual-reality-assisted rehabilitation on the second postoperative day for ten days. The rehabilitation would be carried out two times per day and 30 minutes per training.