Actively Recruiting

Age: 18Years +
All Genders
NCT04855214

Evaluating the Experience of Upper Limb Prosthesis Use

Led by Louis Stokes VA Medical Center · Updated on 2025-04-04

178

Participants Needed

1

Research Sites

302 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluating the Experience of Upper Limb Prosthesis Use

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Ability to give verbal informed consent
  • Ability to speak and understand English
  • Unilateral acquired trans-radial or trans-humeral amputee
  • At least six months from time of limb loss
  • Current user of an upper limb prosthesis
  • Use of the device they will be describing for at least six months (except sensory augmentation)
Not Eligible

You will not qualify if you...

  • Significant hearing impairment preventing telephone communication
  • Unwillingness or inability to discuss experiences with prostheses
  • Emotional disturbance related to discussing the prosthesis or limb loss

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Louis Stokes VA Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

Loading map...

Research Team

M

Melissa S Schmitt, BSN

CONTACT

J

Jessica Jarvela, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here