CompletedNot Applicable

Assessing the DSR Ankle

United States5 participantsStarted 2023-08-22

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓. Adults aged 18-89 years
✓. Patients who have a unilateral transtibial amputation who are able to use a prosthesis and who currently use a passive, non-MPC prosthesis
✓. K2 level ambulators

Exclusion criteria

✕. Pregnant women
✕. Children (\<18 years old)
✕. Prisoners or institutionalized individuals
✕. Individuals who have the inability to give informed consent
✕. Participants unable to walk for 2 minutes without an assistive device
✕. Participants with complicating health conditions that interfere with the study
✕. Inability to read and understand the English language. As this is a pilot study with a small sample size, it is prohibitive to translate Study documents to other languages as recruitment will be from a sample of convenience.

What they're measuring

Minimum Foot Clearance

Timeframe: after up to 3 weeks of training

Time to Foot Flat

Timeframe: after up to 3 weeks of training

Trial details

NCT IDNCT05955378

SponsorSynchro Motion LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-19

Results submitted2025-05-08

View on ClinicalTrials.gov More Amputation trials