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Amputation clinical trials

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NCT ID: NCT05768802 Recruiting - Amputation Clinical Trials

Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation

MIRA
Start date: October 2024
Phase: N/A
Study type: Interventional

The purpose of this research study is to see how well a new type of myoelectric prosthesis works. A myoelectric prosthesis is a robotic limb for amputees that is controlled by sensing the activity of muscles in the body above the amputation level. This study involves a medical procedure to implant the Myoelectric Implantable Recording Array (MIRA) in the residual limb. The procedure will be performed under sedation by a physician. When muscles contract, they generate an electrical signal that can be sensed by MIRA and used to control the prosthetic limb. Myoelectric prosthetic limbs normally use electrodes that are placed on the surface of the skin to control different movements. However, MIRA is implanted under the skin, which could improve the ability to control the myoelectric prosthesis. After the MIRA is implanted, training will occur to learn how to control the prosthesis using the muscles in the residual limb. The device can stay implanted for up to one year. The device will be removed (explanted) by a physician.

NCT ID: NCT05749952 Completed - Amputation Clinical Trials

Digital Weight Bearing Shape Capture Socket Technology

DWB
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

NCT ID: NCT05747066 Active, not recruiting - Amputation Clinical Trials

Nutrition in People With a Lower Limb Amputation

Start date: February 21, 2023
Phase:
Study type: Observational

The goal of this prospective longitudinal observational cohort study is to determine the nutritional intake, nutritional status, and physical activity level in people who have undergone a major dysvascular lower limb amputation (LLA) at different moments post-LLA (during hospital admission several days post-LLA, and at 5 weeks, 6 months, and 9 months post-LLA). The main questions this study aims to answer are: - What is the nutritional intake, nutritional status, and physical activity level at different moments post-LLA? - What is the association between nutritional intake and physical activity level, and nutritional status? - What is the association between nutritional intake, nutritional status and physical activity level and clinical outcomes (mortality, wound healing, quality of life, physical functioning)?

NCT ID: NCT05706818 Completed - Amputation Clinical Trials

Validity and Reliability of the Community Integration Questionnaire-Revised in Lower Limb Amputees

Start date: November 20, 2019
Phase:
Study type: Observational

The goal of this clinical trial is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. The main questions it aims to answer are: - The Turkish version of the Community Integration Questionnaire-Revised is valid for lower extremity amputees. - The Turkish version of the Community Integration Questionnaire-Revised is reliable for lower extremity amputees. Participants will: • Fill out general information, CIQ-R, TAPES, and ABIS forms.

NCT ID: NCT05699174 Recruiting - Amputation Clinical Trials

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

POvIV2
Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

NCT ID: NCT05695911 Recruiting - Amputation Clinical Trials

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

TOPLOAD
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).

NCT ID: NCT05656924 Recruiting - Amputation Clinical Trials

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.

NCT ID: NCT05650931 Enrolling by invitation - Amputation Clinical Trials

Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

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 upper 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: NCT05628064 Not yet recruiting - Amputation Clinical Trials

1C70 Feasibility Study

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to characterize the extend of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.

NCT ID: NCT05615402 Recruiting - Cerebral Palsy Clinical Trials

Intervention on Bone Health in Wheelchair Users

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

The low mechanical loading of bones among wheelchair users leads to an increased risk of bone fractures and associated complications due to low bone mineral density (BMD). Adding mechanical loading through physical activity in combination with optimizing nutrition may counteract these negative consequences in wheelchair users and thereby provide positive impact for bone health, as well as for physical and mental health. In this project, a multidisciplinary team will tailor a bone-specific exercise and nutrition program to increase BMD in sport active and non-active wheelchair users with initial low BMD.