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Amputation clinical trials

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NCT ID: NCT06468059 Active, not recruiting - Amputation Clinical Trials

Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

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

The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.

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: NCT05915065 Active, not recruiting - Amputation Clinical Trials

VR to Evaluate Phantom Limb Pain

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation. We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.

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: NCT05301270 Active, not recruiting - Amputation Clinical Trials

The Dynamic Postural Changes in Transtibial and Transfemoral Amputees

Start date: February 24, 2023
Phase:
Study type: Observational [Patient Registry]

This research was planned to examine how unpredictable movements on the support surface will affect muscle activation and kinematic parameters in individuals with transtibial and transfemoral amputations. Individuals aged between 18-45 years, using prostheses for at least 1 year, able to stand and walk independently without a walking aid, and volunteered to participate in the study with unilateral transtibial and unilateral transfemoral amputation, and healthy individuals similar to these individuals in terms of age and gender will be included in the study.

NCT ID: NCT04903756 Active, not recruiting - Diabetes Mellitus Clinical Trials

PrEdiction of Risk and Communication of outcomE followIng Major Lower Limb Amputation - a collaboratiVE Study

PERCEIVE
Start date: October 1, 2020
Phase:
Study type: Observational

The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.

NCT ID: NCT04536025 Active, not recruiting - Amputation Clinical Trials

Shared Decision Making Aid for Prosthetic Design

D-MAP
Start date: June 6, 2020
Phase:
Study type: Observational

This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.

NCT ID: NCT04069793 Active, not recruiting - Amputation Clinical Trials

Functional Importance of a Powered Multifunction Wrist Protocol

Start date: January 18, 2018
Phase: N/A
Study type: Interventional

The focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. This study will enable the investigator to quantify the relative functional value of powered wrist flexion during both in-laboratory testing and home use. In addition, the investigators will address the effectiveness of different hand-wrist combinations to enhance patient-centered clinical decision making.

NCT ID: NCT04038580 Active, not recruiting - Amputation Clinical Trials

A Comparative Assessment of Transfemoral Prosthetic Sockets

Start date: August 15, 2019
Phase: N/A
Study type: Interventional

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

NCT ID: NCT03930199 Active, not recruiting - Amputation Clinical Trials

Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures, participant-reported measures, and structured interviews to create a clinical toolbox to (i) identify individuals who exhibit reduced prosthesis use (compared to expected usage levels based on K-level designation and/or participant goals of community mobility and social interaction), (ii) identify prosthetic/physical and psychological factors that limit prosthesis use, and (iii) determine the effect of targeted interventions to increase prosthesis use and facilitate achievement of participant goals. Objective sensor-based measurement of home and community activities will allow for the correlation of real-world function to in-clinic assessments and to monitor changes resulting from rehabilitation interventions in real time. Machine-learning and data mining techniques will be used to identify a subset of measures from this toolbox that sensitively and accurately reflect real-world function, enabling clinicians to predict and assess activity and provide effective interventions to optimize prosthesis use. The goal of this project, to improve overall performance with respect to activities of daily living and other real-world activities, thus addresses the Fiscal Year 2017 (FY17) Orthotics and Prosthetics Outcomes Research Program (OPORP) Focus Area of Orthotic or Prosthetic Device Function.