Actively Recruiting
Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology
Led by Louis Stokes VA Medical Center · Updated on 2025-04-04
178
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the factors that influence how people accept and use upper limb prostheses after losing an arm. The study aims to create a unified model that explains the psychological and social experiences of using these devices and predicts outcome acceptance. It also explores experiences with prosthesis education, selection, and training, as well as the impact of psychological and social issues on prosthesis use. Findings will help improve understanding for healthcare providers, device developers, and researchers. The study uses a mixed methods observational design. It includes telephone interviews with 42 participants and surveys with 120 participants who have unilateral upper limb loss at the trans-radial or trans-humeral level and currently use prosthetic devices. Up to 16 participants will join focus groups to provide feedback on the developed model. The study groups include users of body-powered prostheses, single and multi-movement myoelectric prostheses, and those using sensory augmentation technologies. Participants will share their experiences through interviews, surveys, and focus groups. Researchers will collect data on psychosocial factors, prosthesis dexterity, control, sensory feedback, and care experiences. The main outcome measure is the Patient Experience Measure (PEM) assessed over two years. The study will analyze the data to understand prosthesis acceptance and develop a decision tool to better match patients with suitable prosthetic devices. The total duration for participant involvement varies with the study components.
CONDITIONS
Brief Title
Evaluating the Experience of Upper Limb Prosthesis Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (except sensory augmentation users)
You will not qualify if you...
- Significant hearing impairment preventing telephone communication
- Unwillingness or inability to discuss experiences with prostheses
- Emotional disturbance related to discussion of prosthesis or limb loss
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (telephone)
Duration - Up to 2 years
Participants share their experiences and perspectives regarding upper limb prosthesis use through interviews and surveys to help understand factors influencing prosthesis acceptance.
Multiple telephone interviews and survey assessments over the study period
Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
M
Melissa S Schmitt, BSN
J
Jessica Jarvela, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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