Improving prosthetic fitting for Veterans in rural areas using digital technology
Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance
This study is testing if using digital technology to capture the shape of a Veteran's limb at home can help create a well-fitting prosthetic socket without needing multiple trips to the clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05884203 on ClinicalTrials.gov |
What this trial studies
This research aims to enhance the provision of prosthetic sockets for Veterans with lower limb amputations living in rural communities by utilizing digital technology for limb shape capture. Instead of requiring multiple in-person visits to a prosthetist, the study investigates whether an untrained helper can assist in capturing the residual limb shape remotely. The goal is to determine if this method can produce a prosthetic socket that fits as well as those made using traditional casting techniques. By reducing travel burdens and improving access to care, this approach seeks to provide a more efficient and patient-centered solution for prosthetic fitting.
Who should consider this trial
Good fit: Ideal candidates include Veterans with unilateral transtibial amputations who have been using a prosthesis for at least six months and can walk on a treadmill.
Not a fit: Patients who have current skin issues, improper fit with their current prosthesis, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve access to well-fitting prosthetics for Veterans in rural areas, enhancing their mobility and quality of life.
How similar studies have performed: While the approach of using digital technology for prosthetic fitting is innovative, similar studies have shown promise in improving access and outcomes for patients with mobility challenges.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral transtibial amputation * Been fit with a prosthesis and used it for at least 6 months * Wear the prosthesis for 4 or more hours on average per day * Has a prosthesis that bolts to the bottom of the socket * Be at least one-year post-amputation * Able to walk on a treadmill * Have an eligible and available study helper Exclusion Criteria: * Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources * Current skin irritation or injury on residual limb * Osteoarthritis, injury, or pain that interferes with walking ability * Currently incarcerated * Pregnant * Inadequate cognitive function or language proficiency to consent to participate
Where this trial is running
Seattle, Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Glenn K Klute, PhD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Glenn K Klute, PhD
- Email: Glenn.Klute@va.gov
- Phone: (206) 764-2991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.