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Amputation, Traumatic clinical trials

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NCT ID: NCT04547582 Recruiting - Phantom Limb Pain Clinical Trials

Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day

SCS-90
Start date: December 16, 2016
Phase: N/A
Study type: Interventional

The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.

NCT ID: NCT04486534 Completed - Clinical trials for Cartilage Degeneration

The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation

Start date: July 26, 2020
Phase:
Study type: Observational

Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower limb amputation. Although there are many studies on knee joint of intact limb of amputees in the literature, the number of studies on intact foot and ankle is extremely limited. The primary aim of the study is to compare the intact talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee patients with that of healthy individuals using ultrasound. The secondary aim is to investigate the relationship between cartilage and muscle thickness measurements with clinical parameters.

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: NCT04192084 Not yet recruiting - Hand Injuries Clinical Trials

Microvascular Partial Toe Transfer

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

Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits

NCT ID: NCT04078854 Terminated - Sexual Dysfunction Clinical Trials

The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention

Start date: July 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of two types of education on HbA1c level and future amputations in inpatient diabetics after initial minor foot 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.