Evaluating the Experience of Upper Limb Prosthesis Use

Sponsor

Louis Stokes VA Medical Center (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04855214

Collaborator

United States Department of Defense (U.S. Fed)

138

Enrollment

Location

21.5

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prosthesis User Amputation Upper Limb Amputation at the Wrist Upper Limb Amputation Above Elbow (Injury) Upper Limb Amputation Below Elbow (Injury)	Other: Qualitative Analysis

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 Design

Study Type:

Observational

Anticipated Enrollment :

138 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 16, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Patient Experience Measure (PEM) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)