RECRUITING

Evaluating the Experience of Upper Limb Prosthesis Use

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology

Quick Facts

Study Start:2020-12-16
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04855214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Ability to give verbal informed consent
  3. * Ability to speak and understand English
  4. * Unilateral acquired trans-radial or trans-humeral amputee
  5. * At least six months from time of limb loss
  6. * Current user of an upper limb prosthesis
  7. * Use of the device they will be describing for at least six months (with the exception of sensory augmentation)
  1. * Significant hearing impairment which would prevent telephone communication.
  2. * Unwillingness or inability to discuss experiences with prostheses
  3. * Emotional disturbance related to discussion the prosthesis or limb loss

Contacts and Locations

Study Contact

Melissa S Schmitt, BSN
CONTACT
216-791-3800
Melissa.Schmitt@va.gov
Jessica Jarvela, MS
CONTACT
216-791-3800
Jessica.Jarvela@va.gov

Principal Investigator

Emily L Graczyk, PhD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center
Dustin J Tyler, PhD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center

Study Locations (Sites)

Louis Stokes VA Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Louis Stokes VA Medical Center

  • Emily L Graczyk, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center
  • Dustin J Tyler, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-16
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2020-12-16
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Upper Limb Prosthesis User
  • Survey
  • Interview
  • User Experience
  • Body-powered
  • Myoelectric
  • Multiple degree of freedom
  • Sensory Feedback
  • Prosthetic device features
  • Upper Limb Loss
  • Amputee
  • Outcome Acceptance
  • Qualitative Research

Additional Relevant MeSH Terms

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