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Amputation, Traumatic clinical trials

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NCT ID: NCT04484805 Completed - Amputation Clinical Trials

Socket Cooling Effectiveness Take Home Study

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

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.

NCT ID: NCT04456244 Completed - Postural; Defect Clinical Trials

Comparison of Transtibial and Transfemoral Amputees' Posture Parameters

Start date: January 3, 2021
Phase:
Study type: Observational

With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. The aim of this study is to determine the static postural adaptations that appear at different amputation levels.

NCT ID: NCT04272593 Completed - Prosthesis User Clinical Trials

Pattern Recognition Prosthetic Control

Simultaneous
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.

NCT ID: NCT04272489 Completed - Prosthesis User Clinical Trials

Pattern Recognition Prosthetic Control

Adaptation
Start date: December 17, 2020
Phase: N/A
Study type: Interventional

Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control. Conventional control systems require frequent recalibration in order to achieve consistent performance which can lead to prosthetic users choosing to wear their device less. This study investigates a new adaptive pattern recognition control algorithm that retrains, rather than overwrite, the existing control system each instance users recalibrate. The study hypothesis is that such adaptive control system will lead to more satisfactory prosthesis control thus reducing the need for recalibration and increasing how often users wear their device. Participants will wear their prosthesis as they would normally at-home using each control system (adaptive and non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored during each period in order to compare user wear time and recalibration frequency when using adaptive or non-adaptive control. Participants will also play a set of virtual games on a computer at the start (0-months), mid-point (1-months) and end (2-months) of each period that will test their ability to control prosthesis movement using each control system. Changes in user performance will be evaluated during each period and compared between the two control systems. This study will not only evaluate the effectiveness of adaptive pattern recognition control, but it will be done at-home under typical and realistic prosthetic use conditions.

NCT ID: NCT04262297 Completed - Clinical trials for Amputation, Traumatic

Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

Start date: October 1, 2018
Phase:
Study type: Observational

Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial 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: NCT04057989 Completed - Analgesia Clinical Trials

Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

Start date: August 2014
Phase:
Study type: Observational

Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.

NCT ID: NCT03924310 Completed - Clinical trials for Amputation; Traumatic, Hand

Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment

FeetBack
Start date: August 9, 2021
Phase: N/A
Study type: Interventional

State-of-the-art myoelectric prostheses provide upper limb amputees with a remarkable variety of grip patterns but lack proper feedback from touch sensation. This restriction limits the controllability of multi-articulated robotic hands, resulting in the rejection of the device in many cases. Amputees have often reminiscing sensations in the stump, i.e. by touching certain regions, it feels as if no longer existing fingers were touched. These regions form a phantom map and show promising results for touch feedback. However, not every amputee has one and the socket of a prosthesis offers limited space for additional devices. Thus, the investigators developed a feedback display which is worn in the shoe instead of the prosthesis itself. The investigators want to assess the viability of vibrotactile feedback stimulus on the foot as a substitution for pressure on the fingers of an artificial hand in a clinical study. The efforts are based on the hypothesis that a hand prosthesis with tactile feedback has better performance in manipulating fragile and heavy objects, compared with a standard commercial hand prosthesis without tactile feedback.

NCT ID: NCT03876405 Completed - Prosthesis User Clinical Trials

Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses

Start date: April 1, 2015
Phase: N/A
Study type: Interventional

Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.

NCT ID: NCT03498872 Completed - Prosthesis User Clinical Trials

Strategic Research Program 17 (VUB Funding)

Start date: October 1, 2016
Phase: N/A
Study type: Interventional

Objectives: The main objectives are to determine neural dynamics during gait using electro-encephalography as well as brain sources and to investigate the attentional demand during walking in able-bodied individuals, and individuals with an amputation. Materials & Methods: 6 able-bodied individuals conducted one experimental trial, and 6 unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental trials; the first with the current and the second with a novel powered transtibial prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2 walking tasks; 6 and 2min treadmill walking at normal speed interspersed by 5min of rest. During 6min walking the sustained attention to response (go-no go) task, with measures reaction time and accuracy, was performed. Electro-encephalographic (EEG) data were gathered when subjects walked 2min. Motor-related cortical potentials and brain activity during gait are extracted using EEG.