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Amputation clinical trials

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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: NCT04169594 Completed - Stroke Clinical Trials

Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation

Start date: June 19, 2020
Phase:
Study type: Observational

Gait analysis is commonly performed in clinical practice. However, it is complex and requires an understanding of the activation of muscles in lower limbs, trunk, and upper limbs in a specific spatiotemporal pattern and the appropriate joint positions which support and advance the body weight in different phases of gait cycles. In study, we plan to pilot the application of 3D gait analysis with statistical modelling in 2 common causes of gait deviation: unilateral hemiplegic stroke and unilateral lower limb amputation.

NCT ID: NCT04086641 Completed - Amputation Clinical Trials

Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)

Start date: July 22, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the prosthetic socket, rather than the distal end. The hypothesis is that the high-profile foot (i.e., the crossover foot) will lead to functional and biomechanical improvements compared to low-profile feet.

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: NCT04070105 Completed - Amputation Clinical Trials

No Power Bionic Lower Extremity Prosthesis

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

Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.

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: 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: NCT04043234 Completed - Amputation Clinical Trials

RESCU System for Robust Upper Limb Prosthesis Control

RESCU
Start date: November 7, 2023
Phase:
Study type: Interventional

This study will compare the use of RESCU [Experimental] Prosthesis with a [Standard] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.

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: 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.