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Transtibial Amputation clinical trials

View clinical trials related to Transtibial Amputation.

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NCT ID: NCT05989243 Recruiting - Clinical trials for Transfemoral Amputation

Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

SocketFit
Start date: January 31, 2022
Phase:
Study type: Observational

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

NCT ID: NCT04157608 Withdrawn - Clinical trials for Transtibial Amputation

Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Start date: October 2, 2019
Phase: N/A
Study type: Interventional

The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait. The investigators will also evaluate whether prosthetic users are able to wear and use the e-MIP device long-term.

NCT ID: NCT03995238 Recruiting - Diabetes Mellitus Clinical Trials

Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation

GEM
Start date: October 9, 2019
Phase: N/A
Study type: Interventional

The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.

NCT ID: NCT02891707 Active, not recruiting - Clinical trials for Transfemoral Amputation

Mobile Device Outcomes-based Rehabilitation Program

MDORP
Start date: May 2016
Phase: N/A
Study type: Interventional

This joint research project between the Department of Veterans Affairs (VA) and Department of Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based Rehabilitation Program (MDORP) will improve the quality of rehabilitative care at a decreased cost to the healthcare system and a reduced burden for service members (SMs) and veterans with lower limb loss. The development of the MDORP will be executed by a multisite translational clinical care team that will use web-based mobile computing devices designed to assess mobility, enable remote prescription of targeted exercise program, and provide continual measureable outcomes to document the continuum of care with the intent of maximizing prosthetic performance while minimizing adverse medical events. The information obtained from this web-based mobile device application will be used by clinicians to promote continuity of care from the DoD and VA facilities nationwide to the community and at home.

NCT ID: NCT02440711 Completed - Clinical trials for Transtibial Amputation

Evaluation of a Modified Running-specific Prosthetic Foot

Start date: May 2015
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.

NCT ID: NCT02328859 Completed - Clinical trials for Transtibial Amputation

Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation

Start date: April 1, 2016
Phase: Early Phase 1
Study type: Interventional

A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation. The system is composed of a treadmill that can simulate different environmental situations such as walking up stairs and hills and going around curves. The treadmill is synchronized with an immersive display and an avatar of the user. The combination of variable terrain and visual feedback is extremely promising as a means for amputee patients to achieve improved functional mobility after gait training. The proposed work is relevant to public health because it is the first step in developing a novel rehabilitation system that will use visual feedback for gait training in amputees and others with pathological gait disorders. The research is pertinent to the mission of the Department of Veterans Affairs which is committed to improve the quality of life of Veterans with disability.

NCT ID: NCT02026570 Active, not recruiting - Clinical trials for Transtibial Amputation

Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.

Start date: June 2013
Phase: N/A
Study type: Interventional

Objectives: The purpose of this study is to investigate attentional (internal vs. external) focus effects on persons with amputation to perform a defined compensatory movement to reduce the likelihood of a fall. An internal focus of attention directs a person's conscious attention to their body's movements, whereas an external focus of attention directs a person's conscious attention to the effects of their movements or specific features in the environment. Numerous experiments have investigated the effects of an internal and external focus of attention on motor performance and the findings are in favor of an external focus of attention. In our work, we propose a motor learning research experiment to evaluate attentional focus strategies on the rehabilitation outcomes of learning and adaptation to the new proprioceptive information for persons with a recent transtibial amputation. Research Design and Methodology: For this pilot study, six participants with recent unilateral transtibial amputation will be recruited. Four participants will receive internal and external focus of attention training methods while the other two (control group) will receive standard prosthetic training instructions. The experiment will be conducted in three phases: Phase 1 -- Baseline Performance Test, Phase 2 -- Training sessions, and Phase 3 - Learning Test. The training will utilize a vibrotactile device designed to generate tactile sensations at the skin-socket interface simulating contact of the prosthesis with the environment. The sensation simulates a perturbation that signals a potential fall event. During the experiment the augmented sensory information will be introduced randomly while participants walk at a preferred pace on a level surface. Movement kinematics and kinetics of the body will be recorded for analyses using a motion capture system with force plates. Finding: It is hypothesized that the external focus of attention condition will outperform the internal focus of attention condition when responding to perturbations. The external focus of attention condition will yield faster response time and show improved compensatory responses compared to the internal focus of attention group by producing a greater lateral displacement of the artificial limb relative to the line of progression. In addition, the external condition will demonstrate a greater step length and step height than the internal focus of attention condition when provided with a perturbation. Clinical Significance: Current practices within the field of Physical Therapy reveal that there is little therapeutic intervention for fall prevention. Instructions are traditionally provided on how to reduce the risk of falling through preparation of a room or obstacle avoidance or on the proper way to fall to decrease injury. However, there are no protocols for providing a prosthetic user with compensatory strategies to avoid a fall after a perturbation occurs. The research findings can result in improved training protocols, which can improve rehabilitative outcome. Impact/Significance: The growing number of prosthetic users presents a need for improved patient care and effective prosthetic training and rehabilitation methods. Complimentary to the mission of the VA, the results of this research could enhance the quality of patient care and further assist these patients toward becoming prosthetically rehabilitated.

NCT ID: NCT01821976 Completed - Clinical trials for Transtibial Amputation

Transtibial Amputation Outcomes Study

TAOS
Start date: March 2013
Phase: N/A
Study type: Interventional

The goals of the TAOS study is to determine the best procedures for below the knee amputations. There are two different procedures currently used by surgeons around the county: the Erlt procedure and the Burgess procedure. Proponents of the Ertl procedure advocate that the surgical formation of a tibia to fibula bone bridge provides stability, shape and weight bearing capability to the residual limb that result in less pain and better prosthetic fit and alignment. This procedure is popular especially among the military but it's advantages over the Burgess procedure are not well supported by current research. This study aims to compare the two amputation procedures in an adequately powered randomized trial.

NCT ID: NCT00693628 Completed - Clinical trials for Transtibial Amputation

Effects of Shrinker Use on Healing and Volume

Start date: March 2007
Phase: N/A
Study type: Interventional

We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".

NCT ID: NCT00494143 Completed - Clinical trials for Transtibial Amputation

Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot

Start date: July 2007
Phase: Phase 3
Study type: Interventional

To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.