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Amputation, Traumatic clinical trials

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NCT ID: NCT05827744 Recruiting - Clinical trials for Amputation, Traumatic

The Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles

Start date: May 15, 2023
Phase:
Study type: Observational

The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

NCT ID: NCT05786690 Not yet recruiting - Gait Clinical Trials

The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption

Start date: March 23, 2023
Phase:
Study type: Observational

The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

NCT ID: NCT05768802 Recruiting - Amputation Clinical Trials

Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation

MIRA
Start date: March 2024
Phase: N/A
Study type: Interventional

The purpose of this research study is to see how well a new type of myoelectric prosthesis works. A myoelectric prosthesis is a robotic limb for amputees that is controlled by sensing the activity of muscles in the body above the amputation level. This study involves a medical procedure to implant the Myoelectric Implantable Recording Array (MIRA) in the residual limb. The procedure will be performed under sedation by a physician. When muscles contract, they generate an electrical signal that can be sensed by MIRA and used to control the prosthetic limb. Myoelectric prosthetic limbs normally use electrodes that are placed on the surface of the skin to control different movements. However, MIRA is implanted under the skin, which could improve the ability to control the myoelectric prosthesis. After the MIRA is implanted, training will occur to learn how to control the prosthesis using the muscles in the residual limb. The device can stay implanted for up to one year. The device will be removed (explanted) by a physician.

NCT ID: NCT05597696 Completed - Amputation Clinical Trials

Sitting Balance in Lower Limb Amputees

Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

NCT ID: NCT05444868 Completed - Clinical trials for Amputation; Traumatic, Limb, Lower

Validity and Reliability Study of Glittre Activities Of Daily Living Test in Amputees

Start date: July 15, 2022
Phase:
Study type: Observational

Glittre activities of daily living test is used in different populations. The test, which is valid and reliable in different populations, has not been validated in amputees. In our study, we wanted to investigate the validity and reliability of the Glittre activities of daily living test (Glittre ADL) test in amputees using a lower extremity prosthesis.

NCT ID: NCT05435326 Not yet recruiting - Clinical trials for Amputation, Traumatic

The Relationship of Stump Length With Muscle Strength in Patients With Traumatic Unilateral Transfemoral Amputation

Start date: July 18, 2022
Phase:
Study type: Observational

Amputation is the loss or removal of a body part such as an arm or leg. It is the last option in trauma treatment and irreversible procedure. Amputation rehabilitation begins in the pre-amputation period. The goal of rehabilitation after an amputation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life. Many factors can affect the success of lower limb amputation rehabilitation, and stump length is one of them. A sufficient stump length provides a large contact surface and increases the stability of the socket unit.

NCT ID: NCT05328934 Enrolling by invitation - Clinical trials for Amputation, Traumatic

SoftHand Comparison Study

Start date: April 28, 2022
Phase: N/A
Study type: Interventional

A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.

NCT ID: NCT05318508 Completed - Low Back Pain Clinical Trials

Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

Start date: April 10, 2022
Phase:
Study type: Observational

The aim of this study is to investigate the relationship between sagittal spinopelvic parameters and low back pain and quality of life in individuals with lower extremity amputation.

NCT ID: NCT05297266 Recruiting - Ischemia Clinical Trials

Early Discovery of Ischemia After Replantation Surgery of the Extremities

EDIR
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity. IscAlert is measuring continuously CO2 in muscular and subcutaneous tissue. IscAlert is inserted distal to the operative field into normal muscle and/or subcutaneous tissue in the replanted extremity. Local tissue CO2 and temperature will be monitored continuously postoperatively for the next 10 days. If a reduced or totally obstructed blood flow appear (thrombosis), an increase in tissue CO2 and a lower local temperature will emerge rapidly as a sign of ischemia. This will be detected by the sensor which will alarm the investigators. This will lead to assessment of the replanted extremity and if restricted blood flow is diagnosed, a reoperation will be performed. After reoperation new sensors will be implanted for another ten days if applicable. Sixty patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the hospital or a maximum of 10 days (the event that occurs first). 500 devices is planned to be used in this clinical study.

NCT ID: NCT05267639 Recruiting - Amputation Clinical Trials

Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a larger spectrum of patient populations (K2-K4), as well as testing additional Power Knees currently in development that are expected to become commercialized in the near future. The investigators intend to use this Level 2 trial data to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with MPKs is needed to allow for improved clinical decision making and clinical outcomes.