N/A
N=5
Assessing the DSR Ankle
Amputation · Limb Deficiencies
Bottom Line
View on ClinicalTrials.gov: NCT05955378 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Minimum Foot Clearance — 4.07; 3.87 centimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DSR Ankle (Device); Predicate Ankle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synchro Motion LLC
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimum Foot Clearance |
4.07; 3.87 | — |
| PRIMARY Time to Foot Flat |
0.31; 0.27 | — |
| SECONDARY Orthotics Prosthetics User Survey (OPUS) Device Satisfaction |
45; 44.5 | — |
| SECONDARY 10 Meter Walk Test (10 MWT) |
0.41; 0.53 | — |
| SECONDARY Six Minute Walk Test (6 MWT) |
145.1; 162.9 | — |
| SECONDARY Timed Up and Go (TUG) |
42.17; 23.13 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05955378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.