Clinical trial NCT05601869: Impact of Improving Footwear Options
Official title: Impact of Improving Footwear Options for Women Veterans With Amputations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Keywords: Artificial Limbs
Amputation
Leg Prosthesis
Body Image
Community Participation
Social Participation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Minnesota
First posted: 2022-11-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pretest-Posttest Design
Primary purpose: SUPPORTIVE_CARE

Brief summary: Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis will be tested in this project with women Veterans with amputations to determine the impact of improving footwear options on body image and community participation.

Detailed description: Background - Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The investigators seek to understand the impact of improving footwear options for women Veterans with amputations on body image and community participation following a 6-month take-home trial.

Research Questions (Objectives) - The purpose of this project is to evaluate the effect of a new prosthetic ankle-feet system on body image and participation among women Veterans with lower limb amputations.

Relevance to VA - Women Veterans with amputations is a small but growing demographic of US military Veterans. Women with amputations receive more frequent prosthetics care, but are less satisfied with the fit, comfort, and appearance of their prostheses than men. These findings are not surprising as most prosthesis components are not gender-specific and seem to have been designed for men. The investigators' group has developed a 3D-printed ankle feet system customized to fit a wide range of footwear, including shoes of different heel heights and widths. This new prosthesis system dramatically improves footwear options for persons using leg prostheses, enabling potential to increase body image and community participation for women Veterans with leg amputations. This study is an important next step in the investigators' line of research and is needed to determine the impact of improving footwear options for this important and growing subpopulation of Veterans.

Number of Research Participants (Sample Size) - We will recruit up to 18 women Veterans with transtibial amputations to participate and anticipate that at least 12 participants will complete the entire study. The investigators plan to screen women Veterans from a national sample to accomplish the recruitment and completion goals.

Participating Sites - Minneapolis VA Health Care System

Duration of Participant Intake (Study Duration) - This project is projected to occur over three years. The project will begin with a 6-month start-up period and recruitment will continue for two years following start-up. Recruitment will conclude with 6-months remaining in the study timeline, which will be used for dissemination of results and closure of the project.

Treatment (follow-up) - The intervention being tested is a new prosthetic ankle-feet prosthesis that women Veterans will wear for 6-months in their home and community environments. The investigators will follow-up with participants after 1-month and after 6-months of home and community use.

Endpoints - The primary outcomes for this study are body image (Amputee-specific Body Image Scale - Revised) and ability to participate in social roles and activities (PROMIS - Ability to Participate in Social Roles and Activities).

Qualitative Data - In addition to measuring body image and participation, the investigators will conduct semi-structured interviews will participants to develop further understanding of the benefits and drawbacks of using the new prosthetic ankle-feet system. Participants will also complete a photovoice task in which they will be asked to take photos regarding their experience using the new prosthetic ankle-feet system. These photos will then be used as talking points during the semi-structured interview to improve the understanding of the user experience with the system.

Eligibility criteria: Inclusion Criteria:

* US military Veterans that identify as women
* Transtibial (below-knee) amputation
* Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
* Well fitting and well aligned prosthesis
* Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
* Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection

Exclusion Criteria:

* Residual limb skin problems
* Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
* Unable or unwilling to travel to Minneapolis
* Not a regular prosthesis user
* Mass over 125 kg
* Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
* Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)

Primary outcomes:
measure: Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
timeFrame: Baseline, 1-month, 6-months
measure: PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change
timeFrame: Baseline, 1-month, 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Andrew H Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: