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| Name | Class |
|---|---|
| Shirley Ryan AbilityLab | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Predicate Ankle | Active Comparator | The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSR Ankle | Device | This is the experimental ankle component used in the overall prosthetic intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Orthotics Prosthetics User Survey (OPUS) Device Satisfaction | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611-4805 | United States |
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3 of 5 patients completed this cross-over study.
5 patients were enrolled between August 22, 2023 and November 19, 2024 at the Shirley Ryan AbilityLab in Chicago, IL.
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| ID | Title | Description |
|---|---|---|
| FG000 | Predicate Ankle, Then DSR Ankle | Participants first performed assessments with their predicate (daily use) prosthetic ankle. After a washout period of at least 2 weeks, they were trained and assessed with the 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. |
| FG001 | DSR Ankle, Then Predicate Ankle | Participants first performed assessments with the 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. After a washout period of at least 2 weeks, they were trained and assessed with their predicate (daily use) prosthetic ankle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Predicate Ankle, Then DSR Ankle | Participants first performed assessments with their predicate (daily use) prosthetic ankle. After a washout period of at least 2 weeks, they were trained and assessed with the 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | centimeters | after up to 3 weeks of training |
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For each intervention, the period of time for adverse event monitoring was the 3 to 4 hour period during which the device was worn for the in-lab gait sessions. The participants did not wear the experimental intervention for home or daily use in this study.
The risks associated with study participation are no greater than minimal risk as defined in 45 CFR 46.102(i): "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arun Jayaraman | Shirley Ryan AbilityLab | 312-238-6875 | ajayaraman@sralab.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 6, 2025 | May 8, 2025 | Prot_SAP_ICF_000.pdf |
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AB/BA
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| Predicate Ankle | Device | This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention. |
|
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| after up to 3 weeks of training |
| 10 Meter Walk Test (10 MWT) | The 10 MWT assesses walking speed in meters per second over a distance of 10 meters. | after up to 3 weeks of training |
| Six Minute Walk Test (6 MWT) | The 6 MWT assesses walking distance in meters over a period of 6 minutes. | after up to 3 weeks of training |
| Timed Up and Go (TUG) | The TUG assesses mobility, balance, walking ability, and fall risk in older adults. | after up to 3 weeks of training |
| BG001 | DSR Ankle, Then Predicate Ankle | Participants first performed assessments with the 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. After a washout period of at least 2 weeks, they were trained and assessed with their predicate (daily use) prosthetic ankle. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | seconds | after up to 3 weeks of training |
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|
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| Secondary | Orthotics Prosthetics User Survey (OPUS) Device Satisfaction | 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. | Posted | Mean | Standard Deviation | units on a scale | after up to 3 weeks of training |
|
|
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| Secondary | 10 Meter Walk Test (10 MWT) | The 10 MWT assesses walking speed in meters per second over a distance of 10 meters. | Posted | Mean | Standard Deviation | meters per second | after up to 3 weeks of training |
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| Secondary | Six Minute Walk Test (6 MWT) | The 6 MWT assesses walking distance in meters over a period of 6 minutes. | Posted | Mean | Standard Deviation | meters | after up to 3 weeks of training |
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|
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| Secondary | Timed Up and Go (TUG) | The TUG assesses mobility, balance, walking ability, and fall risk in older adults. | Posted | Mean | Standard Deviation | seconds | after up to 3 weeks of training |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Predicate Ankle | The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention. | 0 | 5 | 0 | 5 | 0 | 5 |
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