Evaluating the Experience of Upper Limb Prosthesis Use

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855214
• Other study ID #: 20-02
• Status: Recruiting
• Start date: December 16, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2021
• Source: Louis Stokes VA Medical Center
• Contact: Alesia N Lambert, BS
• Phone: 440-645-8710
• Email: axl854[@]case.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Prosthesis User
• Upper Limb Amputation at the Wrist
• Upper Limb Amputation Below Elbow (Injury)
• Wounds and Injuries

Intervention

Other:
• Qualitative Analysis
Mixed methods analysis of the user's experience with upper limb prosthetics.

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two years