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Clinical Trial Summary

Our goal is to understand the critical factors associated with outcome acceptance following upper limb loss. We 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. 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 two-year 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 18 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.


Clinical Trial Description

Background Use of an upper limb prosthesis can improve function and quality of life, but these devices are frequently abandoned or used only intermittently. Two critical reasons for abandonment identified by prosthesis rejecters are insufficient prosthesis functionality and insufficient sensory feedback. Living with major limb loss is a complex experience involving multiple physical, psychological, and social factors. While many studies have investigated the needs and design priorities of prosthesis users, few have investigated how prosthesis features interact with other psychosocial aspects of the prosthesis use experience and overall attitude towards or acceptance of the device (outcome acceptance). To provide better prosthetic device options and improve rehabilitation outcomes, we must understand the relationships between prosthesis functional and sensory capabilities, the subjective experience of the prosthesis, and outcome acceptance following limb loss. Objective Our goal is to understand the critical factors associated with outcome acceptance following upper limb loss. We 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. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. Specific Aims - Specific Aim 1: Assess the impact of the experience of prosthesis dexterity and control on outcome acceptance. - Specific Aim 2: Assess the impact of sensory feedback experience on outcome acceptance. - Specific Aim 3: Refine the theoretical model derived from qualitative analyses by exploring the quantitative relationships between aspects of the model of outcome acceptance. Hypotheses Qualitative analyses will yield a theoretical model of outcome acceptance that includes psychosocial factors and prosthetic device factors related to dexterity, control, and sensory feedback. We hypothesize that experiences of prosthesis dexterity, control, and sensory feedback will both directly influence and modulate psychosocial factors of prosthesis use and user attitudes. We hypothesize that quantitative data collected through survey research will triangulate findings from the qualitative analyses, confirm the directionality of the conceptual relationships, and predict the relative weightings of relationships. Study Design 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 18 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration and analyses of standardized measures quantifying constructs of the theoretical model in 120 participants and use of these measures in 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04855214
Study type Observational
Source Louis Stokes VA Medical Center
Contact Alesia N Lambert, BS
Phone 440-645-8710
Email [email protected]
Status Recruiting
Phase
Start date December 16, 2020
Completion date September 30, 2022

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