Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistan
When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural
| Condition(s) | Lower Extremity Amputation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in-person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. The investigators seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socke |
| Who can participate | 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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | VA Office of Research and Development |
| Locations | Seattle, Washington, United States |
| Start date | 2023-07-01 |
| NCT ID | NCT05884203 |
| Official listing | https://clinicaltrials.gov/study/NCT05884203 |