NCT05955378

Assessing the DSR Ankle

Assessment of a Microprocessor Ankle for Low Mobility Individuals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Synchro Motion LLC · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle. The DSR ankle is a new design to support a person while they walk on both even and uneven ground, as well as with bending the ankle for safe foot clearance while a person takes a step. In particular, in this study we are interested in seeing how this type of new device may benefit people who are rated as a K2-level ambulator.

Detailed description

Synchro Motion, LLC developed a novel MPC ankle. Because of its unique actuation scheme, the prosthesis can behave as: (1) a lockable conformal damper, (2) a variable set-point spring, and (3) an actively repositionable joint. The investigators therefore refer to the device as the damping, stiffness, and repositioning (DSR) ankle. The DSR ankle is small, lightweight, quiet, and runs for multiple days on a single charge. No other commercially available prosthesis combines this set of features. It will be shown in preliminary work that the features of the DSR ankle can increase toe clearance in swing, reduce the time-to-foot-flat after heel strike, and improve weight bearing symmetry when standing on slopes for K3 Individuals with Lower Limb Amputation (ILLAs). These biomechanical functions have all been linked to improved safety and stability, which leads the investigators to hypothesize that the DSR ankle may provide benefits to K2 ILLAs as well. The main purpose of this research is to determine the ways in which the DSR ankle may be adapted to provide benefits specifically to ILLAs who use their prosthesis at the K2 level. For purposes of the Phase I work, the development and assessment will be performed exclusively with K2 ILLAs in order to provide an opportunity to implement any necessary refinements to the DSR ankle to ensure optimal K2 performance. The remainder of the research is to quantify the effectiveness of the DSR ankle as compared to a predicate non-MPC ankle in improving performance for K2 ILLAs.

Conditions

• Amputation
• Limb Deficiencies

Interventions

Type	Name	Description
DEVICE	DSR Ankle	This is the experimental ankle component used in the overall prosthetic intervention.
DEVICE	Predicate Ankle	This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.

Timeline

• Start date: 2023-08-22
• Primary completion: 2024-11-19
• Completion: 2024-12-19
• First posted: 2023-07-21
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

1 site across 1 country: United States