Assessing the DSR Ankle
- Conditions
- AmputationLimb Deficiencies
- Interventions
- Device: DSR AnkleDevice: Predicate Ankle
- Registration Number
- NCT05955378
- Lead Sponsor
- Synchro Motion LLC
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DSR Ankle DSR Ankle 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. Predicate Ankle Predicate Ankle The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living.
- Primary Outcome Measures
Name Time Method Minimum Foot Clearance 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.
Time to Foot Flat 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 Outcome Measures
Name Time Method Orthotics Prosthetics User Survey (OPUS) 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.
10 Meter Walk Test (10 MWT) after up to 3 weeks of training The 10 MWT assesses walking speed in meters per second over a distance of 10 meters.
Six Minute Walk Test (6 MWT) after up to 3 weeks of training The 6 MWT assesses walking distance in meters over a period of 6 minutes.
Functional Gait Assessment (FGA) after up to 3 weeks of training The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking.
Hill Assessment Index (HAI) after up to 3 weeks of training The HAI is scored on an ordinal scale from 0 to 11 and measures the patient's ability to navigate sloped terrain.
Timed Up and Go (TUG) after up to 3 weeks of training The TUG assesses mobility, balance, walking ability, and fall risk in older adults.
Trial Locations
- Locations (1)
Shirley Ryan AbilityLab
🇺🇸Chicago, Illinois, United States