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Amputation clinical trials

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NCT ID: NCT04392466 Recruiting - Amputation Clinical Trials

Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals

Start date: February 15, 2020
Phase:
Study type: Observational

In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.

NCT ID: NCT04388488 Recruiting - Amputation Clinical Trials

Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System

Start date: August 3, 2020
Phase: N/A
Study type: Interventional

The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.

NCT ID: NCT04248725 Recruiting - Multiple Sclerosis Clinical Trials

Telehealth Pain Self-Management for Employed Adults

E-TIPS
Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.

NCT ID: NCT04238533 Recruiting - Amputation Clinical Trials

Enhanced Auto-Diagnostic Adaptive Precision Trainer for Myoelectric Prosthetic Users

eADAPT
Start date: March 18, 2020
Phase: N/A
Study type: Interventional

The eADAPT training consists of a variety of mobile games played on a mobile app (phone or tablet). A band is worn on the residual limb. Participants use muscle activation to send signals to execute certain movements in the game.

NCT ID: NCT04230512 Recruiting - Amputation Clinical Trials

Hybrid Pump Technology

HIPPI
Start date: April 4, 2020
Phase: N/A
Study type: Interventional

Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over other techniques including improved limb health and mobility. A new pump design will be tested by prosthesis users in the laboratory to verify its functionality during walking.

NCT ID: NCT04212299 Recruiting - Amputation Clinical Trials

Transfemoral Socket Design and Muscle Function

Start date: September 24, 2019
Phase: N/A
Study type: Interventional

The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in Service members, Veterans, and civilians who use above-the-knee prostheses. Traditional above-the-knee socket designs provide pelvic support that interferes with hip motion. They may also reduce the effort required from amputated limb hip muscles to stabilize the hip and amputated limb, risking further loss of muscle mass and strength beyond that due to amputation. Long-standing use of above-the-knee sockets with pelvic support may therefore intensify amputated limb muscle loss and weakness, leading to challenges with walking and balance, increasing the effort required to walk, and contributing to degenerative changes in the hips and knees. Alternative socket designs that lessen the loss of muscle mass and strength are therefore required. The investigators have developed a new socket without pelvic support for above-the-knee prosthesis users called the Northwestern University Flexible Sub-Ischial Suction (NU-FlexSIS) Socket. This new socket design increases user comfort and is often preferred by users over sockets with pelvic support. This new socket does not lessen the mechanical function of the socket, or walking and balance performance. Our recent research suggests that walking with this new socket may also increase amputated limb hip muscle size. However, more research is needed to demonstrate that this new socket design improves amputated limb hip muscle strength and endurance, leading to better function. A socket design that increases amputated limb hip muscle strength and endurance would provide a simple way to restore amputated limb hip muscle weakness in above-the-knee prosthesis users. Despite a considerable decrease in hip muscle size and strength due to amputation surgery, amputated limb hip muscles are expected to compensate for the loss of knee and ankle function by providing stability and propulsion during walking. Walking in the new socket design without pelvic support is expected to increase amputated limb hip muscle strength and endurance, providing an appealing alternative to traditional resistance training in order to retain hip muscle strength. Unlike traditional resistance training, using this new socket design would not require additional time or equipment, and may be effective just by walking in the home, community, or workplace. Due to existing infrastructure (e.g., ongoing clinical adoption of the NU-FlexSIS Socket, existing instructional materials and courses for fabrication and fitting of the NU-FlexSIS Socket, as well as a continuing partnership with Chicago's largest provider of prosthetic clinical care), the investigators anticipate being able to translate our research results to clinical practice by the end of the project period. The investigators expect the results of the proposed pilot research project to directly and positively benefit the health and well-being of Service members, Veterans, and civilians who are above-the-knee prosthesis users. Benefits of increasing amputated limb hip muscle strength and endurance may include: i) improved control over the prosthesis, ii) better balance, iii) reduced effort to walk, and iv) protection against joint degeneration. For Service members these benefits could improve their performance on challenging and/or uneven ground, and increase the distance and speed they can walk or run. For Veterans, these benefits could lead to greater independence during activities of daily living, and fewer falls, reducing the physical and emotional burden on family members and caregivers.

NCT ID: NCT04083456 Recruiting - Diabetes Mellitus Clinical Trials

Dysvascular Amputation Self-Management of Health

DASH
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

NCT ID: NCT04063592 Recruiting - Amputation Clinical Trials

AMI Construction in Lower Extremity Residual Limbs

Start date: February 24, 2020
Phase: N/A
Study type: Interventional

This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy

NCT ID: NCT04038151 Recruiting - Amputation Clinical Trials

Intuitive Control of a Hybrid Prosthetic Leg During Ambulation

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The objective of this research is to determine the clinical benefits of an innovative and lightweight powered leg controlled using our intent recognition framework in laboratory and community environments.

NCT ID: NCT03989063 Recruiting - Diabetes Mellitus Clinical Trials

Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Inadequate rehabilitation training after amputation can result in poor patient outcomes, injuries, and wasted healthcare resources. This is a serious public health problem due to an aging population and rising prevalence of diabetes (main cause of amputation in the U.S.). In this study, the investigators will examine the effects of external vs. internal attentional focus instruction on learning of a balance task in individuals with existing amputation and those at risk of amputation (older adults with diabetes). With the proposed research, the investigators aim to expand the understanding of motor learning in individuals with and at risk of lower limb loss to provide knowledge that will lead to more effective and efficient rehabilitation.