Assessing the DSR Ankle

NCT05955378 | Completed Results

• 1 other identifier: STU00217993
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Limb Deficiencies

Keywords

Amputation; Transtibial; K2; Limited Community Ambulator

Outcome Measures

Primary Outcomes (2)

• Minimum Foot Clearance

  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.

  after up to 3 weeks of training

• Time to Foot Flat

  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.

  after up to 3 weeks of training

Secondary Outcomes (4)

• Orthotics Prosthetics User Survey (OPUS) Device Satisfaction

  after up to 3 weeks of training

• 10 Meter Walk Test (10 MWT)

  after up to 3 weeks of training

• Six Minute Walk Test (6 MWT)

  after up to 3 weeks of training

• Timed Up and Go (TUG)

  after up to 3 weeks of training

Study Arms (2)

DSR Ankle

EXPERIMENTAL

The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector.

Device: DSR Ankle

Predicate Ankle

ACTIVE COMPARATOR

The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living.

Device: Predicate Ankle

Interventions

DSR Ankle DEVICE

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

Also known as: The Damping, Stiffness and Repositioning Ankle

DSR Ankle

Predicate Ankle DEVICE

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

Also known as: Daily Use Ankle

Predicate Ankle

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synchro Motion LLC: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611-4805, United States

Location

Results Point of Contact

• Title: Arun Jayaraman
• Organization: Shirley Ryan AbilityLab

ajayaraman@sralab.org

312-238-6875

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: AB/BA

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 21, 2023
• Study Start: August 22, 2023
• Primary Completion: November 19, 2024
• Study Completion: December 19, 2024
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)