Understanding the experiences of upper limb prosthesis users
Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology
This study is trying to understand how people who use upper limb prostheses feel about them and what affects their acceptance, to help match them with the right devices and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 178 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Louis Stokes VA Medical Center Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04855214 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the psychosocial factors influencing the acceptance of upper limb prostheses among individuals who have experienced limb loss. By employing a mixed methods approach, the study will gather qualitative and quantitative data through surveys and interviews to develop a theoretical model that captures the user experience and predicts outcomes related to prosthesis use. The findings will inform the creation of a decision tool to better match individuals with appropriate prosthetic devices, ultimately enhancing rehabilitation and quality of life for users.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are unilateral trans-radial or trans-humeral amputees and have been using an upper limb prosthesis for at least six months.
Not a fit: Patients who may not benefit from this study include those with significant hearing impairments or emotional disturbances that hinder their ability to discuss their prosthesis experiences.
Why it matters
Potential benefit: If successful, this study could lead to improved matching of prosthetic devices to users, enhancing their functionality and acceptance.
How similar studies have performed: While many studies have focused on prosthesis functionality, this study's comprehensive approach to understanding psychosocial factors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Emily L Graczyk, PhD — Louis Stokes VA Medical Center
- Study coordinator: Melissa S Schmitt, BSN
- Email: Melissa.Schmitt@va.gov
- Phone: 216-791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.