Assessing the DSR Ankle
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: DSR Ankle
This is the experimental ankle component used in the overall prosthetic intervention.
Other Names:
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| Active Comparator: Predicate Ankle The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. |
Device: Predicate Ankle
This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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.
- Maximum Lyapunov Exponent [after up to 3 weeks of training]
The maximum Lyapunov exponent is a measure of dynamic gait stability that uses nonlinear time series analysis.
- Weight Bearing Symmetry [after up to 3 weeks of training]
Weight bearing symmetry is a measure of standing stability represented by the ratio of left to right side weight bearing.
- Center of Pressure RMS Velocity [after up to 3 weeks of training]
Center of pressure RMS velocity is measured by calculating the velocity of the COP from force plate data while standing.
Secondary Outcome Measures
- 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.
- Numerical Pain Rating Scale (NPRS) [after up to 3 weeks of training]
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
- Borg Rating Scale (RPE) [after up to 3 weeks of training]
The RPE is a tool for measuring an individual's effort and exertion, breathlessness and fatigue during physical work.
- Modified Falls Efficacy Scale (mFES) [after up to 3 weeks of training]
The mFES indicates the level of perceived confidence an individual has about carrying out everyday activities without falling. The modified version includes outdoor activities.
- 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.
- Berg Balance Test (BBS) [after up to 3 weeks of training]
The BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18-89 years
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Patients who have a unilateral transtibial amputation who are able to use a prosthesis and who currently use a passive, non-MPC prosthesis
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K2 level ambulators
Exclusion Criteria:
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Pregnant women
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Children (<18 years old)
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Prisoners or institutionalized individuals
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Individuals who have the inability to give informed consent
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Participants unable to walk for 2 minutes without an assistive device
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Participants with complicating health conditions that interfere with the study
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Synchro Motion LLC
- Shirley Ryan AbilityLab
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00217993