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.
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
- Conditions the study is for
- Prosthesis User, Amputation, Upper Limb Amputation at the Wrist
- 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
- Recruiting
Louis Stokes VA Medical Center
Cleveland, Ohio, 44106
Holly Henry, 216-791-3800 ext. 64657, Holly.Henry@va.gov
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.
- Conditions
- Prosthesis User, Amputation, Upper Limb Amputation at the Wrist, Upper Limb Amputation Above Elbow (Injury), Upper Limb Amputation Below Elbow (Injury)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Qualitative Analysis | |
| Single degree-of-freedom (DOF) myoelectric prosthesis users | Individuals who use a myoelectric prosthesis that can perform only one movement. Receives: Other: Qualitative Analysis | |
| Multi-DOF myoelectric prosthesis users | Individuals who use a myoelectric prosthesis that can perform more than one movement. Receives: Other: Qualitative Analysis | |
| 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. Receives: Other: Qualitative Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted22 Apr 2021
- Study start16 Dec 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emily Graczyk, Louis Stokes VA Medical Center
- Investigators
- Emily L Graczyk, PhD, Principal investigator, Louis Stokes VA Medical CenterDustin J Tyler, PhD, Principal investigator, Louis Stokes VA Medical Center
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology
- ClinicalTrials.gov ID
- NCT04855214
- Acronym / sponsor ID
- 20-02
- Conditions
- Prosthesis User, Amputation, Upper Limb Amputation at the Wrist, Upper Limb Amputation Above Elbow (Injury), Upper Limb Amputation Below Elbow (Injury)
- Keywords
- Upper Limb Prosthesis User, Survey, Interview, User Experience, Body-powered, Myoelectric, Multiple degree of freedom, Sensory Feedback
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Body-powered Prosthesis User | – | Other: Qualitative AnalysisIndividuals 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. |
| Single degree-of-freedom (DOF) myoelectric prosthesis users | – | Other: Qualitative AnalysisIndividuals who use a myoelectric prosthesis that can perform only one movement. |
| Multi-DOF myoelectric prosthesis users | – | Other: Qualitative AnalysisIndividuals who use a myoelectric prosthesis that can perform more than one movement. |
| Sensory Augmentation | – | Other: Qualitative AnalysisIndividuals who experience augmented prosthesis sensory feedback through vibrating devices or pressure bladders, using electrical stimulation applied to the residual limb, or using neural implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative AnalysisAlso: Mixed MethodsMixed methods analysis of the user's experience with upper limb prosthetics. | Other | Body-powered Prosthesis User, Multi-DOF myoelectric prosthesis users, Sensory Augmentation, Single degree-of-freedom (DOF) myoelectric prosthesis users |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. De-identified data will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily L Graczyk, PhD principal investigator
Louis Stokes VA Medical Center
Dustin J Tyler, PhD principal investigator
Louis Stokes VA Medical Center
1 site in 1 country: see every site and its status.
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.