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Amputation, Traumatic clinical trials

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NCT ID: NCT05220553 Not yet recruiting - Amputation Clinical Trials

A Sensorimotor Prosthesis for the Upper Limb

PROLIMB
Start date: March 31, 2022
Phase: N/A
Study type: Interventional

The finger and fingertip are the most frequently amputated body parts, due to work-related incidents. Yet because of space, weight and cost constraints, prosthetic fingers and fingertips are heavy and bulky with limited active motion and sensation. Most are basic variations on the hook and claw. Lower limb prostheses have become extremely technologically advanced in their design and materials, and upper limbs lag behind in all of these areas. This is due to the complexity of the anatomy and function of the upper limb compared to the lower. There are no commercially available prostheses that offers direct sensory feedback and as such, rely on visual feedback from the wearer. The original PROLIMB study (PROLIMB I) used a Leap Motion Controller (LMC) to investigate the type of grasp adaptation that have been undertaken by patients during the rehabilitation process following amputation and compared this to similar data from healthy volunteers. PROLIMB I also looked at refining the tactile feedback system by investigating the sensation felt on amputation sites in order to feed this information into the haptic feedback system. The vision of the PROLIMB II project is to build on the work completed in PROLIMB I and develop and combine mechanistic models of hand motion and haptic sensing to deliver novel, affordable body-powered prosthetic fingertip digits with enhanced motion and sensation to address current clinical needs and support the quality of life of amputees. With collaboration from the University of Warwick (UoW) and University College London (UCL), Steeper Group and Naked Prosthetics the PROLIMB II study will aim to model, design, fabricate and validate a body-powered prosthetic fingertip digit with integrated sensory feedback. The University Hospital Coventry & Warwickshire (UHCW) will provide the clinical facility with which to assess the comfort, usability and acceptance of this prosthetic in the daily lives of patients with digit amputations. This project will be a proof of concept study with verification of the prosthetic in motion capture (gait) laboratories as well as the use of simple validation data collection over a longer period.

NCT ID: NCT05188599 Completed - Clinical trials for Amputation, Traumatic

Isokinetic Parameters and the Amputee Mobility Predictor Scale

Start date: March 1, 2022
Phase:
Study type: Observational

There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. It is hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation.

NCT ID: NCT05177341 Not yet recruiting - Clinical trials for Amputation, Traumatic

Investigating The Effect of Phantom Sensation on Gait in Individuals With Unilateral Below-Knee Amputation

Start date: January 2022
Phase:
Study type: Observational

Amputation is a problem that can be encountered for many reasons, can cause functional disability in varying severities and puts a multifaceted financial burden on individuals, society, and states. The phantom feeling is the state of the sensory sensation of a limb that does not already exist and is observed in various forms in individuals with amputation. The aim of this project is to investigate whether the phantom sensation affects autocorrelation of gait in unilateral amputated individuals and thus to determine whether the phantom sensation is a functional sensation that affects the multifaceted nature of gait. In addition, the measurement of whether phantom sensation contributes to the ability of amputees to adapt to changing conditions and obtaining a unique calculation method that determines autocorrelation are other specific aspects of the study. The study will be conducted on individuals with unilateral traumatic transtibial amputation who have acceptable phantom sensation, individuals with no-phantom sensation and healthy individuals. Individuals who meet the inclusion criteria will be included in the gait assessment. During the evaluation, at least 512 consecutive steps will be collected from each individual when walking on the treadmill at their preferred speed. The walk test will then be repeated on the perturbation treadmill of 5-10%. It will be determined whether the gait characteristics obtained by gait analysis show autocorrelation by using signal processing methods.

NCT ID: NCT05155735 Recruiting - Clinical trials for Amputation; Traumatic, Hand

Functional Outcomes of Single Digit Replantation Versus Revision Amputation

Start date: January 17, 2023
Phase:
Study type: Observational

The purpose of this study is to compare functional outcomes in single digit replantation subjects compared with revision amputation. Functional outcomes will be assessed by DASH (disabilities of the arm, shoulder and hand) score and with Purdue Pegboard Test by the subject's respective hand therapist at their last visit. Results will contribute to generating a preoperative decision algorithm for single digit amputation injuries.

NCT ID: NCT05112679 Completed - Amputation Clinical Trials

Limb Health and Socket Pressure in Response to Powered Ankle Protheses

OPORP
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.

NCT ID: NCT05059886 Completed - Clinical trials for Traumatic Amputation

The Injury and Its Consequences in the Sports Lower Limb Amputee

PREV'AMP SPORT
Start date: January 11, 2022
Phase:
Study type: Observational

This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact. It aims to study sports-related injuries in lower limb amputees. Its objective is to determine the prevalence, but also to describe the injuries (type, location, duration, type of management) and their repercussions in terms of after-effects, and repercussions on sports, professional and personal practice. It also aims to begin a correlation between injury and sports load, type of sport (discipline, practice modality), technical aids used

NCT ID: NCT05048394 Completed - Clinical trials for Amputation; Traumatic, Arm, Upper

Teleoperation Experimental Comparison With Able-bodied Subjects

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

To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. In a randomized order, subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. A TASKA prosthetic hand will be sensorized using the Point Touch technology. Then, the subjects will perform the ACMC outcome measure using each experimental condition. Trained observers will record the measure. Then, a direct comparison can be made both within subject performance and across subjects for the semi-autonomous control algorithm developed in Aim 2.1 and the standard of care myoelectric system used in the TASKA prosthetic hand.

NCT ID: NCT05038566 Completed - Amputation Clinical Trials

Dexterous Partial Hand Prosthesis Outcomes

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participants' existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.

NCT ID: NCT05012683 Completed - Clinical trials for Amputation; Traumatic, Hand

To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees

Start date: January 5, 2021
Phase: N/A
Study type: Interventional

This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment. The use of the Point Partial outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.

NCT ID: NCT05012657 Completed - Clinical trials for Amputation; Traumatic, Hand

Validation of Point Partial User Needs With Partial Finger Amputees

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

The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.