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OpenTrials
Completed

NCT Number: NCT05955378

Assessing the DSR Ankle

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611-4805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSR Ankle

Device

This is the experimental ankle component used in the overall prosthetic intervention.

Other names: The Damping, Stiffness and Repositioning Ankle

Predicate Ankle

Device

This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.

Other names: Daily Use Ankle

Primary outcomes

  1. Minimum Foot Clearance

    Time frame: after up to 3 weeks of training

    Minimum foot clearance is the shortest distance between the foot and the ground during swing, and it occurs approximately halfway through the swing phase of gait.

  2. Time to Foot Flat

    Time frame: after up to 3 weeks of training

    Time to foot flat is the duration of time between initial contact at heel strike and the full contact of the sole of the foot on the ground in stance.

Secondary outcomes

  1. Orthotics Prosthetics User Survey (OPUS) Device Satisfaction

    Time frame: after up to 3 weeks of training

    The OPUS is a self-report questionnaire consisting of 5 modules. It can be used for prosthetic and orthotic programs for quality assessment, to maintain awareness of improvement in activities, to evaluate changes in patient's functional status and quality of life, and to assess satisfaction with devices and services. The Device Satisfaction module uses a 5-point Likert scale (1 to 5), with a total score range of 11 to 55. Higher values indicate higher levels of satisfaction.

  2. 10 Meter Walk Test (10 MWT)

    Time frame: after up to 3 weeks of training

    The 10 MWT assesses walking speed in meters per second over a distance of 10 meters.

  3. Six Minute Walk Test (6 MWT)

    Time frame: after up to 3 weeks of training

    The 6 MWT assesses walking distance in meters over a period of 6 minutes.

  4. Timed Up and Go (TUG)

    Time frame: after up to 3 weeks of training

    The TUG assesses mobility, balance, walking ability, and fall risk in older adults.

Sponsors and collaborators

Lead sponsor

Synchro Motion LLC

Industry

Collaborators

  • Shirley Ryan AbilityLab

Registry information

Official study title

Assessment of a Microprocessor Ankle for Low Mobility Individuals

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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