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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Qualitative Analysis

    Other intervention

    Mixed methods analysis of the user's experience with upper limb prosthetics.

Treatment groups

178 Participants
are divided into 4 treatment groups
Group A: Body-powered Prosthesis User1 intervention
Group B: Single degree-of-freedom (DOF) myoelectric prosthesis users1 intervention
Group C: Multi-DOF myoelectric prosthesis users1 intervention
Group D: Sensory Augmentation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Two years

Secondary outcomes

Other outcomes

Sponsors and contacts

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