Evaluating the Experience of Upper Limb Prosthesis Use

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLouis Stokes VA Medical Center

About this trial

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 criteria

Qualifiers

18 years or older

Ability to give verbal informed consent

Ability to speak and understand English

Unilateral acquired trans-radial or trans-humeral amputee

Disqualifiers

Significant hearing impairment which would prevent telephone communication.

Unwillingness or inability to discuss experiences with prostheses

Emotional disturbance related to discussion the prosthesis or limb loss

Trial design

Treatments tested in this trial

  • Qualitative Analysis

Treatment groups

178 Participants
are divided into 4 treatment groups

Sponsors and collaborators