Evaluating the Experience of Upper Limb Prosthesis Use

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Louis Stokes VA Medical Center
Study ID
NCT04855214
Status
Recruiting
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Conditions

  • Amputation
  • Prosthesis User
  • Upper Limb Amputation Above Elbow (Injury)
  • Upper Limb Amputation Below Elbow (Injury)
  • Upper Limb Amputation at the Wrist

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Qualitative Analysis — OTHER
    Mixed methods analysis of the user's experience with upper limb prosthetics.

Study Details

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.

Key Dates

Start date
Dec 16, 2020
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
178 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Single degree-of-freedom (DOF) myoelectric prosthesis users
    Individuals who use a myoelectric prosthesis that can perform only one movement.
  • Arm: Multi-DOF myoelectric prosthesis users
    Individuals who use a myoelectric prosthesis that can perform more than one movement.
  • Arm: 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.

Primary Outcome Measure

Patient Experience Measure (PEM) [ Time Frame: Two years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical CenterClevelandOhio44106
Holly Henry
[email protected]
216-791-3800

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By research site
Louis Stokes VA Medical Center· Cleveland, OH

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