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Prosthesis User clinical trials

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NCT ID: NCT06361966 Completed - Amputation Clinical Trials

Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets

Start date: January 11, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model. The main question[s] it aims to answer are: 1. To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods. 2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method. 3. To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket. Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis. Participants will attend 6 visits across a total duration of 11 weeks during the course of the study.

NCT ID: NCT06357143 Not yet recruiting - Prosthesis User Clinical Trials

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

Start date: January 2025
Phase: N/A
Study type: Interventional

The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.

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: NCT06109792 Completed - Prosthesis User Clinical Trials

Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques

Start date: April 10, 2021
Phase: N/A
Study type: Interventional

This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture

NCT ID: NCT06109519 Completed - Prosthesis User Clinical Trials

Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture

Start date: February 16, 2020
Phase: N/A
Study type: Interventional

This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments

NCT ID: NCT06105944 Completed - Amputation Clinical Trials

Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation

Start date: December 17, 2022
Phase:
Study type: Observational

The goal of this retrospective questionnaire study is to evaluate the cost-effectiveness of non-microprocessor controlled prosthetic knees (NMPK) versus microprocessor controlled prosthetic knees (MPK) in persons with a knee-disarticulation or transfemoral amputation. The main aims are: - to provide an overview of the costs, health-related quality of life, and user experiences associated with the use of different types of prosthetic knees. - to evaluate the cost-effectiveness of the NMPK compared to the MPK for adult prosthesis users. Participants will fill out three questionnaires about (1) their medical consumption and productivity costs; (2) health-related quality of life; (3) utility, ambulation and well-being. Researchers will compare the persons with a NMPK to the persons with an MPK to investigate the cost-efficiency of both types of knees.

NCT ID: NCT06100354 Active, not recruiting - Orthopedic Disorder Clinical Trials

Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.

FKprefPat
Start date: December 12, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are: - What is the acceptability of new customization and connectivity technologies by patients? - Are they all at the same level of acceptability? Participants will have to answer to a questionnaire of choice.

NCT ID: NCT06052501 Not yet recruiting - Prosthesis User Clinical Trials

3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations

Start date: March 30, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. In a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient. The use of 3D facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.

NCT ID: NCT06031922 Recruiting - Amputation Clinical Trials

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

Start date: June 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to investigate the effectiveness of NMPKs versus MPKs in persons with an LLA in the standard healthcare system in the Netherlands taking all levels of the ICF model into account. Our main aim is to assess the effect of MPK use compared to NMPK use on walking distance, as this is one of the most used outcome variables in literature and thus enables comparison with previous studies. Our secondary aim is to investigate the effect of NMPKs versus MPKs on all ICF-levels: body structures and function, activities and participation. Participants will be seen four times in a year. During these measurement moments they will: - Perform two physical tests - Fill out a set of questionnaires - Wear an activity tracker for one week

NCT ID: NCT05999539 Completed - Quality of Life Clinical Trials

Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Start date: August 25, 2023
Phase:
Study type: Observational

Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.