Actively Recruiting
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
Eligibility Criteria
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)
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
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Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
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
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