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Amputation clinical trials

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NCT ID: NCT03433300 Completed - Amputation Clinical Trials

Microprocessor Knees in Early Rehabilitation

Start date: April 13, 2018
Phase: N/A
Study type: Interventional

High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury. The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.

NCT ID: NCT03411148 Completed - Physical Activity Clinical Trials

Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Start date: April 5, 2018
Phase: N/A
Study type: Interventional

Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.

NCT ID: NCT03409133 Recruiting - Amputation Clinical Trials

Feasibility of Sensory Feedback for Lower Limb Amputees

Start date: November 5, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

NCT ID: NCT03390153 Completed - Amputation Clinical Trials

Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees

Start date: April 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo making our prosthetic system a more comfortable experience for the prosthetic user.

NCT ID: NCT03389334 Completed - Amputation Clinical Trials

Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees

Start date: March 29, 2018
Phase: N/A
Study type: Interventional

The purpose of this graduate research study is to explore the therapeutic benefits of Myofascial Release massage on lower limb amputees with pain levels, range of motion, and muscle strength.

NCT ID: NCT03383640 Not yet recruiting - Amputation Clinical Trials

Early Active Finger Exercises in Replanted Fingers

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

A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.

NCT ID: NCT03374319 Active, not recruiting - Amputation Clinical Trials

Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

The hypothesis of this research protocol is that we will be able to redesign the manner in which lower limb amputations are performed so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses. The specific aims of the project are as follows: 1. To define a standardized approach to the performance of a novel operative procedure for both below knee (BKA) and above knee (AKA) amputations 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive and other sensory feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BKA and AKA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

NCT ID: NCT03350061 Completed - Amputation Clinical Trials

Prosthesis With Sensations

Start date: November 12, 2017
Phase: N/A
Study type: Interventional

Lower limb amputees suffer complete lack of sensory feedback of current available prostheses, which excludes the central nervous system from the correct sensory-motor integration. It causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive burden, and phantom limb pain occurrence. Investigators will provide amputees with a prosthesis restoring sensory feedback and will assess its benefits on the users.

NCT ID: NCT03329326 Completed - Amputation Clinical Trials

Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome

Start date: November 1, 2017
Phase:
Study type: Observational

Background and rational: A large number of instruments exists to assess upper limb prosthetic function. However, they differ substantially in terms of psychometric properties and content. Furthermore, there is no "gold standard" and nearly every single center uses a unique set of instruments. This fact prevents the linking of the commonly small (due to the limited number of patients in each center) data sets of different centers and makes comparisons between different fittings or treatment protocols difficult. To generate accepted evidence, we need large data sets with similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in the recent years, the need to evaluate the impact of this intervention on daily life, including productivity, self-care and leisure becomes increasingly relevant. Moreover, self-reported instruments and observation-based instruments exist, but there is a lack of data if, for example, the self-reported instrument (which is easier and less health-professional's-time-consuming to perform) could "replace" a performance or observation-based instrument. Therefore, the aim of this study is to determine psychometric properties of the existing instruments (SHAP, DASH, SF-36 and ACMC) in a large international data set, to explore possible linkage between self-reported and performance or observation-based instruments and to develop state-of-the art recommendations/points to consider on how to assess functioning in prosthetic care.

NCT ID: NCT03326115 Not yet recruiting - Amputation Clinical Trials

Effectiveness of a Peer Visitation Program to Improve Patient Activation and Quality of Life During Amputation Rehabilitation

AC PVP
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

There is no known interventional clinical trial evidence for existing support and the reintegration strategy of a peer visitation program following amputation. The Amputee Coalition Peer Visitation Program is the only national and VA recognized program for amputees, however, it has not been rigorously tested for effectiveness. Therefore, the objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC PVP) will improve functional outcomes for Service Members, Veterans, and civilians during amputation rehabilitation.