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
This trial does not accept healthy volunteersQualifiers
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 population
The proposed study will recruit a total of 138 persons with unilateral upper limb loss at the trans radial or trans humeral level. Participants may be users of any currently available prosthetic device brand, model, or terminal device, as long as their prosthesis can be classified into one of the four groups : 1) body-powered prosthesis users, 2) single degree-of-freedom (DOF) myoelectric prosthesis users, 3) multi-DOF myoelectric prosthesis users, and 4) user's who experience augmented sensory feedback in their prosthesis.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Qualitative Analysis
Other interventionMixed methods analysis of the user's experience with upper limb prosthetics.
Treatment groups
Trial outcomes
Primary outcomes
Patient Experience Measure (PEM)
Measures the participant's perception of various psychosocial outcomes including self-efficacy, embodiment, body image, prosthesis efficiency, and social touch. It is rated 0-4, where a higher score in each sub-scale indicates a better outcome.
Sponsors and contacts
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