Evaluating the Experience of Upper Limb Prosthesis Use

April 19, 2021 updated by: Dustin J.Tyler PhD, Louis Stokes VA Medical Center

Evaluating the Impact of Prosthetic Device Features on the Experience of Prosthesis Use

Our goal is to understand the critical factors associated with outcome acceptance following upper limb loss. We 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. 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 two-year 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 18 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Use of an upper limb prosthesis can improve function and quality of life, but these devices are frequently abandoned or used only intermittently. Two critical reasons for abandonment identified by prosthesis rejecters are insufficient prosthesis functionality and insufficient sensory feedback. Living with major limb loss is a complex experience involving multiple physical, psychological, and social factors. While many studies have investigated the needs and design priorities of prosthesis users, few have investigated how prosthesis features interact with other psychosocial aspects of the prosthesis use experience and overall attitude towards or acceptance of the device (outcome acceptance). To provide better prosthetic device options and improve rehabilitation outcomes, we must understand the relationships between prosthesis functional and sensory capabilities, the subjective experience of the prosthesis, and outcome acceptance following limb loss.

Objective Our goal is to understand the critical factors associated with outcome acceptance following upper limb loss. We 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. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes.

Specific Aims

  • Specific Aim 1: Assess the impact of the experience of prosthesis dexterity and control on outcome acceptance.
  • Specific Aim 2: Assess the impact of sensory feedback experience on outcome acceptance.
  • Specific Aim 3: Refine the theoretical model derived from qualitative analyses by exploring the quantitative relationships between aspects of the model of outcome acceptance.

Hypotheses Qualitative analyses will yield a theoretical model of outcome acceptance that includes psychosocial factors and prosthetic device factors related to dexterity, control, and sensory feedback. We hypothesize that experiences of prosthesis dexterity, control, and sensory feedback will both directly influence and modulate psychosocial factors of prosthesis use and user attitudes. We hypothesize that quantitative data collected through survey research will triangulate findings from the qualitative analyses, confirm the directionality of the conceptual relationships, and predict the relative weightings of relationships.

Study Design 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 18 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration and analyses of standardized measures quantifying constructs of the theoretical model in 120 participants and use of these measures in 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.

Study Type

Observational

Enrollment (Anticipated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alesia N Lambert, BS
  • Phone Number: 440-645-8710
  • Email: axl854@case.edu

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Louis Stokes VA Medical Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The proposed study will recruit a total of 138 persons with unilateral upper limb loss at the trans radial or trans humeral level. Participants may be users of any currently available prosthetic device brand, model, or terminal device, as long as their prosthesis can be classified into one of the four groups : 1) body-powered prosthesis users, 2) single degree-of-freedom (DOF) myoelectric prosthesis users, 3) multi-DOF myoelectric prosthesis users, and 4) user's who experience augmented sensory feedback in their prosthesis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Qualitative Analysis
Mixed methods analysis of the user's experience with upper limb prosthetics.
Other Names:
  • Mixed Methods
Single degree-of-freedom (DOF) myoelectric prosthesis users
Individuals who use a myoelectric prosthesis that can perform only one movement.
Other: Qualitative Analysis
Mixed methods analysis of the user's experience with upper limb prosthetics.
Other Names:
  • Mixed Methods
Multi-DOF myoelectric prosthesis users
Individuals who use a myoelectric prosthesis that can perform more than one movement.
Other: Qualitative Analysis
Mixed methods analysis of the user's experience with upper limb prosthetics.
Other Names:
  • Mixed Methods
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.
Other: Qualitative Analysis
Mixed methods analysis of the user's experience with upper limb prosthetics.
Other Names:
  • Mixed Methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experience Measure (PEM)
Time Frame: Two years
Measures the participant's perception of various psychosocial outcomes including self-efficacy, embodiment, body image, prosthesis efficiency, and social touch. It is rated 0-4, where a higher score in each sub-scale indicates a better outcome.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Stokes VA Medical Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Dustin J Tyler, PhD, 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 Major Dates

Study Start (ACTUAL)

December 16, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (ACTUAL)

April 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data will be made available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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