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Prosthesis UserNCT04855214

Evaluating the Experience of Upper Limb Prosthesis Use

An observational study of Prosthesis User and Amputation, run by Louis Stokes VA Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Qualitative Analysis
How many people
178 participants
Where
1 siteUnited States
Study dates
16 Dec 2020to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Louis Stokes VA Medical Center

    Cleveland, Ohio, 44106

    Holly Henry, 216-791-3800 ext. 64657, Holly.Henry@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology

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.

Read the 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, investigators must understand the relationships between prosthesis functional and sensory capabilities, the subjective experience of the prosthesis, and outcome acceptance following limb loss.

Objective 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. 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 Aim 1: Assess the impact of the experience of prosthesis dexterity and control on outcome acceptance. Aim 2: Assess the impact of sensory feedback experience on outcome acceptance. Aim 3: Refine the theoretical model derived from qualitative analyses by exploring the quantitative relationships between aspects of the model of outcome acceptance. Aim 4: Examine how access to care and experiences with care shape acceptance of prosthetic devices Aim 5: Examine how perceived societal views affect prosthesis choice and acceptance Aim 6: Examine how patient-specific needs interact with expectations about device benefits and limitations to impact prosthesis acceptance Aim 7: Utilize clinician input and findings from qualitative analyses to design a prototype decision tool (TOP-MATCH) to facilitate matching patients with upper limb prostheses

Hypotheses For aims 1-3: 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.

For aims 4-7: The long-term goal of this line of research is to improve satisfaction with and adoption of upper limb prostheses. The overarching objectives of this proposal are to 1) produce a grounded theory explaining how patient-specific needs, expectations, psychosocial factors, and care experiences interact with prosthetic device features to drive prosthesis acceptance and 2) use this framework to develop a prototype decision tool to assist with matching persons to prostheses. The theoretical model will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use. The clinical decision tool will incorporate the theoretical model to help clinicians and researchers navigate patient-specific needs and preferences to better optimize patient-specific technology prescription and identify best approaches to mitigate device abandonment. The research findings will be useful for increasing prosthesis satisfaction and decreasing rejection rates, ultimately helping providers and health systems make decisions to utilize resources judiciously.

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 42 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. Using the above information, 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model created.

Being tested
Qualitative Analysis
Keywords
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
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qualitative AnalysisOther

    Also called Mixed Methods

    Mixed methods analysis of the user's experience with upper limb prosthetics.

Study groups in NCT04855214
Study groupRoleWhat they receive
Body-powered Prosthesis UserIndividuals 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.
Receives: Other: Qualitative Analysis
Single degree-of-freedom (DOF) myoelectric prosthesis usersIndividuals who use a myoelectric prosthesis that can perform only one movement.
Receives: Other: Qualitative Analysis
Multi-DOF myoelectric prosthesis usersIndividuals who use a myoelectric prosthesis that can perform more than one movement.
Receives: Other: Qualitative Analysis
Sensory AugmentationIndividuals who experience augmented prosthesis sensory feedback through vibrating devices or pressure bladders, using electrical stimulation applied to the residual limb, or using neural implants.
Receives: Other: Qualitative Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Experience Measure (PEM)

    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.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start16 Dec 2020
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855214
Sponsor's protocol ID
20-02
Status last verified
Aug 2026
First submitted
19 Apr 2021
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data will be made available upon request.

Questions about this trial

What is this clinical trial studying?

An observational study of Prosthesis User and Amputation, run by Louis Stokes VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa S Schmitt, BSN (216-791-3800 ext. 63801, Melissa.Schmitt@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Experience Measure (PEM) (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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Evaluating the Experience of Upper Limb Prosthesis Use | AzTrials