Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Minneapolis Veterans Affairs Medical Center | FED |
| INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro) | UNKNOWN |
| University of Washington | OTHER |
Not provided
Not provided
Not provided
Not provided
The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.
One of the most important components of restoring function in persons with lower limb amputation is the precise fitting of the prosthetic socket to the residual limb. However, this is challenging because the residual limb is dynamic in shape and volume. Additionally, prosthetic socket fabrication processes influence socket fit. These processes typically consist of residual limb shape capture, positive mold rectification, initial diagnostic socket fitting, and definitive prosthesis delivery. The most prevalent residual limb shape capture method involves a negative wrap cast in a non-weight bearing position and manual manipulation of the cast to conform to the residual limb shape. With this technique it is challenging to accurately capture the bony contours and distribute pressure evenly around the residual limb. To improve shape capture, techniques that rely less on manual manipulation by the prosthetist, such as standing hydrostatic pressure casting with a water cylinder have been developed. Given the use of physics to shape the residual limb, it has been proposed that pressure casting results in better fitting and more comfortable sockets, however this has not yet been demonstrated. The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Casting | Active Comparator | hand cast will be taken using a circumferential plaster of Paris or fiber glass wrap of the residual limb with the subject in a seated position |
|
| standing hydrostatic pressure casting with a water cylinder | Active Comparator | hand cast will be taken using a circumferential plaster of Paris wrap of the residual limb with the subject in a seated position. The residual limb is then placed into the Symphonie Aqua System while in a weight bearing standing position. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symphonie Aqua SystemTM | Device | a water filled cylinder that can be pressurized around the residual limb to support body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Socket Comfort Score | Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket | at study completion, 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cast/Socket volume | digitized volume and shape of cast and socket | at every study visit, up to 1 month |
| Procedure time | Time to cast, rectify and fit the socket |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Gard, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUPOC | Chicago | Illinois | 60611 | United States | ||
| Minneapolis VA Heath Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41270063 | Derived | Fatone S, Gravely A, Cutti AG, Hansen AH, Gard SA; Residual Limb Shape Capture Group. Randomized crossover trial of hand and hydrostatic casting for custom lower limb prosthetic sockets: Assessing socket comfort and fabrication time. PLoS One. 2025 Nov 21;20(11):e0337185. doi: 10.1371/journal.pone.0337185. eCollection 2025. |
Not provided
Not provided
Data generated by the funded research will be made available to the research community and to the public under the auspices of the PI. Prior to sharing, data will be de-identified and redacted to reduce the risk of subject identification.
Not provided
Data will be shared after acceptance for publication of the main findings from the final dataset.
The PI will share data upon request with anyone via a unique link to a file or folder within Northwestern Box. A data-sharing agreement will be used to ensure that the data is only used for the purpose described, users acknowledge the data source in any use of the data, agree to provide the PI with copies of any presentation or publication that uses the data, prohibit sharing of the data with others without those parties having their own data use agreement, and prohibit manipulation of data for the purposes of identifying subjects.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2024 | Aug 2, 2024 | ICF_000.pdf |
Not provided
Prospective, multi-center, assessor-blinded, cross-over study
Not provided
Not provided
Not provided
| Hand Casting | Procedure | plaster of Paris or fiberglass bandages are wrapped around the residual limb |
|
| at every study visit, 1 month |
| Socket Fit | checklist will be used to assess fit of socket | at study completion, 1 month |
| Socket preference | subject's preference for socket to continue wearing | at study completion, 1 month |
| Minneapolis |
| Minnesota |
| 55417 |
| United States |
| INAIL | Bologna | Emilia-Romagna | 40139 | Italy |