Clinical trial NCT04855214: Evaluating the Experience of Upper Limb Prosthesis Use
Official title: Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Prosthetic device features
Upper Limb Loss
Amputee
Outcome Acceptance
Qualitative Research
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
First posted: 2021-04-22
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Experience Measure (PEM)
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center
name: Emily L Graczyk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louis Stokes VA Medical Center
name: Dustin J Tyler, PhD
role: PRINCIPAL_INVESTIGATOR
References: