Evaluating the Experience of Upper Limb Prosthesis Use
Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology
1 other identifier
observational
178
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2020
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
April 4, 2025
April 1, 2025
5.8 years
April 19, 2021
April 1, 2025
Conditions
Keywords
Outcome Measures
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.
Two years
Study Arms (4)
Body-powered Prosthesis User
Individuals who use a prosthesis that relies on a system of cables or harnesses which are operated using other parts of the body like the shoulders, chest, or elbows.
Single degree-of-freedom (DOF) myoelectric prosthesis users
Individuals who use a myoelectric prosthesis that can perform only one movement.
Multi-DOF myoelectric prosthesis users
Individuals who use a myoelectric prosthesis that can perform more than one movement.
Sensory Augmentation
Individuals who experience augmented prosthesis sensory feedback through vibrating devices or pressure bladders, using electrical stimulation applied to the residual limb, or using neural implants.
Interventions
Mixed methods analysis of the user's experience with upper limb prosthetics.
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes VA Medical Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Emily L Graczyk, PhD
Louis Stokes VA Medical Center
- PRINCIPAL INVESTIGATOR
Dustin J Tyler, PhD
Louis Stokes VA Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Career Scientist
Study Record Dates
First Submitted
April 19, 2021
First Posted
April 22, 2021
Study Start
December 16, 2020
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
De-identified data will be made available upon request.