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Amputation, Traumatic clinical trials

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NCT ID: NCT06433648 Recruiting - Amputation Clinical Trials

Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.

NCT ID: NCT06420687 Recruiting - Amputation Clinical Trials

GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices

Start date: April 20, 2020
Phase: N/A
Study type: Interventional

The goal of this study is to utilize the Gaze and Movement Assessment (GaMA) metric to assess the effect of different prosthetic components on compensatory movements used to complete activities of daily living.

NCT ID: NCT06334146 Recruiting - Clinical trials for Amputation; Traumatic, Leg, Lower

Tap Dance for Adults With Lower Limb Amputation

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence. There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA. Participants will be asked to: - come to 1 hour dance classes, once per week, for 8 weeks. - do mobility tests before and after the program - complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks.

NCT ID: NCT06293443 Recruiting - Amputation Clinical Trials

Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

NCT ID: NCT06284733 Completed - Clinical trials for Amputation; Traumatic, Leg, Lower

Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees

Start date: November 5, 2023
Phase: N/A
Study type: Interventional

This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital. All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

NCT ID: NCT06284005 Completed - Amputation Clinical Trials

Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral Level

MOTU-ATP
Start date: July 27, 2020
Phase: N/A
Study type: Interventional

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees. The main question it aims to answer are: - Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device. - Provide an indication of the functional effectiveness of the device and its satisfaction by patients. Participants will perform: - walking tests inside parallel bars on flat and/or inclined terrain; - walking tests on treadmill; - stair climbing/descent tests.

NCT ID: NCT06194838 Recruiting - Amputation Clinical Trials

Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

Start date: September 12, 2023
Phase: N/A
Study type: Interventional

The goal of this proposed project is to gather community-based data from the K2-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 intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population 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 the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.

NCT ID: NCT06161961 Completed - Amputation Clinical Trials

Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations

Start date: July 21, 2020
Phase: N/A
Study type: Interventional

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees. The main question it aims to answer are: - Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device. - Provide an indication of the functional effectiveness of the device and its satisfaction by patients. Participants will perform: - walking tests inside parallel bars on flat and/or inclined terrain; - walking tests on treadmill; - stair climbing/descent tests.

NCT ID: NCT06071715 Recruiting - Phantom Limb Pain Clinical Trials

Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted individuals, and there is currently no reliable definitive treatment. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that actually increase with worsening phantom pain. These abnormal changes may often be corrected by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain with a simultaneous resolution of the phantom limb pain. However, when the nerve block resolves after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation are not necessarily fixed, and may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many months rather than hours-may permanently reverse the abnormal changes in the brain, and provide definitive relief from phantom pain. A prolonged nerve block lasting a few months may be provided by freezing the nerve using a process called "cryoneurolysis". The ultimate objective of the proposed research study is to determine if cryoanalgesia is an effective treatment for intractable post-amputation phantom limb pain. The proposed pilot study will include subjects with an existing above-knee amputation who experience intractable daily phantom limb pain. A single ultrasound-guided treatment of cryoneurolysis (or sham block-determined randomly like a flip of a coin) will be applied to the major nerves of the thigh. Although not required, each subject may return 4-6 months later for the alternative treatment (if the first treatment is sham, then the second treatment would be cryoneurolysis) so that all participants have the option of receiving the active treatment. Subjects will be followed for a total of 12 months with data collected by telephone.

NCT ID: NCT05929508 Recruiting - Clinical trials for Traumatic Amputation of Lower Extremity

Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the relationship between thigh strength and walking ability and assess if using a blood pressure cuff on the leg improves strength and walking performance.