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Amputation clinical trials

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NCT ID: NCT03097978 Completed - Amputation Clinical Trials

Comparison of Pattern Recognition Control and Direct Control in TMR

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

Targeted Muscle Reinnervation increases the control signals available for commercial arm systems. A new type of control, pattern recognition, has been developed into a form that allows use with commercially available arm system. The goal of this project is a home trial, in which people who have had TMR will try the new controls and the new arm to find out if they are better than what is currently available. Home trials will also allow us to see what needs to be done to make our inventions work even better.

NCT ID: NCT03012529 Recruiting - Diabetes Clinical Trials

Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics

VA INTREPID
Start date: January 22, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.

NCT ID: NCT02988310 Not yet recruiting - Amputation Clinical Trials

Comparison of Gait Characteristics in Individuals With Above and Below Knee Limb Loss

Start date: December 2016
Phase: N/A
Study type: Observational

Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.

NCT ID: NCT02958553 Completed - Amputation Clinical Trials

EmPOWERing Active Seniors With Energy

EASE
Start date: February 10, 2017
Phase: N/A
Study type: Interventional

A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.

NCT ID: NCT02886936 Completed - Amputation Clinical Trials

Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

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

iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials. The aim of this project is to assess the design, user satisfaction and feasibility of this device. The investigators will be fitting transtibial and transfemoral amputees with the iFIT prosthetic system. Patients will wear the device for 2 weeks in order to compare the device to their own prosthetic (if they currently have one). They will report any device breakages or adverse events. They will also fill out a questionnaire to determine if the iFIT prosthetic is a feasible option for treating patients with limb loss.

NCT ID: NCT02864693 Completed - Amputation Clinical Trials

Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees

Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.

NCT ID: NCT02859740 Completed - Amputation Clinical Trials

Validation of the SIGAM/VF Mobility Grade

SIGAM
Start date: August 2013
Phase: N/A
Study type: Observational

The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.

NCT ID: NCT02800434 Completed - Amputation Clinical Trials

Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases

Start date: January 2000
Phase: N/A
Study type: Interventional

The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities. The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution. The objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph

NCT ID: NCT02773056 Completed - Amputation Clinical Trials

Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

Start date: June 2016
Phase: N/A
Study type: Interventional

The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.

NCT ID: NCT02766387 Enrolling by invitation - Amputation Clinical Trials

Evaluation of Correlations Between Different Walk Tests in Patients With Transfemoral Amputees

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

Lower limb amputation (LLA) is a major public health problem, with significant human and financial impact. Epidemiological data remain scarce in the literature. The primary objective of the equipment of lower limb amputees is to give a walking ability and autonomy that are closest to the previous state before the amputation. About microprocessor-controlled prosthetic knees (MPKs), there are currently three in France who benefit from support by health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France). These prostheses have the common feature of being equipped with a single-axis prosthetic knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking speed changes. They are indicated in the proximal amputations of the lower limbs from knee disarticulation included. Their prescription can only be made by a doctor of Physical Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et Prestations Remboursables). This criteria are the ability to: have a walking speed greater than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk down the stairs step by step. These criteria must be validated after a minimum trial period of 15 days. These attribution criteria raise the question today of how they are measured, no recommendation defining this procedure. While many standardized assessment tests of different gait parameters are available and used in clinical research, the attribution criteria are not being built in reference to these tests. The overall objective of the study is to evaluate the diagnostic value of two simple clinical tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).