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Evaluating the Experience of Upper Limb Prosthesis Use

NCT04855214 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Prosthesis User
  • Amputation
  • Upper Limb Amputation at the Wrist
  • Upper Limb Amputation Above Elbow (Injury)
  • Upper Limb Amputation Below Elbow (Injury)

Interventions

OTHER

Qualitative Analysis

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

Sponsors & Collaborators

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Emily L Graczyk, PhD · Louis Stokes VA Medical Center

  • Dustin J Tyler, PhD · Louis Stokes VA Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855214 on ClinicalTrials.gov