Evaluating the Experience of Upper Limb Prosthesis Use

Recruiting now

Conditions studied: Prosthesis User, Amputation, Upper Limb Amputation at the Wrist, Upper Limb Amputation Above Elbow (Injury), Upper Limb Amputation Below Elbow (Injury)

In brief

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.

Key facts

Study ID

NCT04855214

Run by

Louis Stokes VA Medical Center

People needed

178

Starts

2020-12-16

Expected to finish

2026-09-30

Last updated by the study team

2025-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (with the exception of sensory augmentation)

You may not qualify if…

• 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

Where it is running

• Louis Stokes VA Medical Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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