RecruitingNCT04855214

Evaluating the Experience of Upper Limb Prosthesis Use

Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology


Sponsor

Louis Stokes VA Medical Center

Enrollment

178 participants

Start Date

Dec 16, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is focused on understanding the lived experience of people who use upper limb prostheses — artificial arms or hands. Rather than testing a new device or treatment, researchers want to hear directly from prosthesis users about what works well, what is frustrating, and how using a prosthesis affects daily life. This kind of qualitative research helps designers and clinicians build better, more useful devices. Participants will take part in a telephone interview where they discuss their experiences with their prosthesis. The conversation will cover topics such as comfort, function, emotional adjustment, and how well the device meets their needs in everyday activities. You may be eligible if: - You are 18 years or older - You have had a single arm amputation (below or above the elbow) from injury or illness - It has been at least 6 months since your amputation - You currently use an upper limb prosthesis - You have been using the specific device you'll describe for at least 6 months - You can speak and understand English You may NOT be eligible if: - You have significant hearing loss that prevents phone communication - You are unwilling or unable to discuss your prosthesis or limb loss - Discussing your prosthesis or limb loss causes you significant emotional distress Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERQualitative Analysis

Mixed methods analysis of the user's experience with upper limb prosthetics.


Locations(1)

Louis Stokes VA Medical Center

Cleveland, Ohio, United States

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NCT04855214


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