NCT04855214 Evaluating the Experience of Upper Limb Prosthesis Use
| NCT ID | NCT04855214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Louis Stokes VA Medical Center |
| Condition | Prosthesis User |
| Study Type | OBSERVATIONAL |
| Enrollment | 178 participants |
| Start Date | 2020-12-16 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 178 participants in total. It began in 2020-12-16 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Emily L Graczyk, PhD
PRINCIPAL INVESTIGATOR
Louis Stokes VA Medical Center
Frequently Asked Questions
Who can join the NCT04855214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prosthesis User. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04855214 currently recruiting?
Yes, NCT04855214 is actively recruiting participants. Contact the research team at Melissa.Schmitt@va.gov for enrollment information.
Where is the NCT04855214 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT04855214 clinical trial?
NCT04855214 is sponsored by Louis Stokes VA Medical Center. The principal investigator is Emily L Graczyk, PhD at Louis Stokes VA Medical Center. The trial plans to enroll 178 participants.