Assessment of a Microprocessor Ankle for Low Mobility Individuals
Phase: NA
Conditions: Amputation, Limb Deficiencies
Sponsor: Synchro Motion LLC

Title: Assessment of a Microprocessor Ankle for Low Mobility Individuals 
NCT #: NCT05955378 
Document Date: 
05/06/2025 
 
Protocol and StaƟsƟcal Analysis Plan 
 
 

1. Study Aim, Background and Design 
Over 600,000 people in the US had a major lower limb amputaƟon in 2005, and that 
number is expected to double by 2050 [1]. Within this populaƟon, up to 44% of individuals 
are classiﬁed as low mobility prostheƟc users or below (described subsequently) [2]. Major 
lower limb amputaƟons are deﬁned as those with at least an ankle amputaƟon, and as such, 
all these individuals require at least an ankle prosthesis to restore ambulatory mobility. 
The Centers for Medicare and Medicaid Services (CMS) deﬁnes a range of Medicare 
FuncƟonal ClassiﬁcaƟon Levels (MFCLs) through the Healthcare Common Procedure Coding 
System (HCPCS) to categorize mobility levels for individuals with lower limb amputaƟon 
(ILLAs) [3]. These levels, which range from zero to four, are referred to as K-levels. The HCPCS 
also includes codes for prostheƟc and orthoƟc devices, preﬁxed with the leter ‘L’, and known 
as L-codes. This classiﬁcaƟon aids in medical coding for reimbursement, as diﬀerent K-levels 
qualify for diﬀerent L-codes. Although intended for Medicare use, private insurers use these 
guidelines to determine whether to reimburse for services or devices, and how much to pay 
for them. Consequently, the devices for which an individual is deemed eligible are determined 
by their mobility level. 
A criƟcal disƟncƟon between mobility levels is the transiƟon from K2 to K3. The 
disƟnguishing feature of the K3 mobility level is “the ability or potenƟal for ambulaƟon with 
variable cadence” [3]. An individual who qualiﬁes as K3 is able to access a wider range of L-
codes, and, in turn, more advanced devices. However, the nature of the prostheƟc 
intervenƟon aﬀects the ease with which someone can vary their cadence. Furthermore, MPC 
prostheses have been shown not only to help K2 users transiƟon to K3 [4], but also to improve 
safety measures [5, 6] that are equally, if not more, relevant to the K2 populaƟon. 
Synchro MoƟon, LLC developed a novel MPC ankle that is based upon actuator technology 
originally from Vanderbilt University. Because of its unique actuaƟon scheme, the prosthesis 
can behave as: (1) a lockable conformal damper, (2) a variable set-point spring, and (3) an 
acƟvely reposiƟonable joint. The invesƟgators therefore refer to the device as the damping, 
sƟﬀness, and reposiƟoning (DSR) ankle. Compared to a fully powered prosthesis, the DSR 
ankle is small, lightweight, quiet, and runs for mulƟple days on a single charge. 
The aim of this project is to conduct a preliminary invesƟgaƟon into the potenƟal mobility, 
stability, and safety beneﬁts of the DSR prostheƟc ankle-foot for persons with amputaƟon at 
a K2-level. Although the DSR ankle was originally developed for K3/K4 individuals with lower 
limb amputaƟon (ILLAs), the invesƟgators hypothesize that the DSR ankle may also beneﬁt K2 
ILLAs. The Center for Bionic Medicine (CBM) at the Shirley Ryan AbilityLab (SRALab) in Chicago 
and Synchro MoƟon have partnered in order to perform a pilot study to quanƟfy the 
eﬀecƟveness of the proposed ankle as compared to a predicate non-MPC ankle in improving 
performance for K2 individuals with lower limb amputaƟon. 
 
2. ParƟcipant PopulaƟon 
The parƟcipant populaƟon consists of adults (aged between 18 and 89 years) who have a 
unilateral transƟbial amputaƟon and who are able to wear and use a prosthesis and who 

currently use a passive, non-MPC prosthesis. All subjects are expected to be healthy 
individuals. The proposed study will require subjects to be ﬁted with the DSR ankle, using 
their own socket, and to receive training using both their own prosthesis and the DSR ankle. 
Subjects will be recruited from the prostheƟcs and orthoƟcs clinic and physicians at the 
SRALab or through an SRALab registry lisƟng individuals with amputaƟons who are willing to 
parƟcipate in research. They may also include people who have previously taken part in 
research projects at the Center for Bionic Medicine (CBM) or SRALab. Subjects will undergo 
prostheƟc ﬁƫng, training, and outcomes tesƟng at the SRALab. 
 
3. Study Procedures 
Subjects will be recruited and provide informed consent before enrolling in this study. 
Once the subject has given writen consent to parƟcipate, a clinician will interview the 
subjects and do an appropriate exam with respect to the amputated limb and their ability to 
use a prosthesis. Subjects will be examined to determine the range of moƟon and strength in 
all of their extremiƟes including the amputated limb. We will obtain a brief medical history, 
indicaƟng when their amputaƟon was performed and what type of prosthesis and assisƟve 
device they use. Subjects will also undergo a brief physical exam to ensure they meet the 
inclusion criteria, and we will collect residual limb measurements and obtain subjects’ weight 
and height. 
The DSR ankle will be atached to the parƟcipant’s own socket (parƟcipants will each have 
at least 2 visits for device ﬁƫng). For each ankle, subjects will receive approximately 4 training 
sessions over two weeks (1-2 per week), followed by a 3-4 assessment sessions. All training 
and tesƟng will take place in the laboratory. AŌer tesƟng with the ﬁrst device is complete, 
there will be a 2-week washout before training and tesƟng on the second device.  
No specimens will be obtained from subjects. We will obtain informaƟon from standard 
performance measures and paƟent-reported measures. All data will be collected at the 
SRALab. 
 
4. StaƟsƟcal Analysis Plan 
This is a preliminary pilot study intended to gather the iniƟal data necessary for proper 
staƟsƟcal design and power calculaƟons in a subsequent Phase II proposal. Because pilot data 
has not yet been collected on the target populaƟon, power calculaƟons are not currently 
possible. Furthermore, since the number of subjects in this study is small, the staƟsƟcal power 
from this study on its own is likely to be low, but it is hoped that the results will jusƟfy a Phase 
II study that is likely to achieve staƟsƟcally signiﬁcant results with a reasonable sample size. 
 
5. Research Risks 
The risks of the experimental part of the study are small.  
• The largest risk is the risk of falling, which is a risk for all lower limb prosthesis users.  
• Other risks include minor skin irritaƟon, minor muscle soreness, and faƟgue.  

• There is some risk that subjects’ idenƟƟes may be revealed as a result of parƟcipaƟng 
in this study.  
• There are no other known social, legal, or other risks in these experiments.  
 
6. Funding Sources 
This work is funded by the Eunice Kennedy Shriver NaƟonal InsƟtute of Child Health and Human 
Development through a Phase I STTR award. 
 
7. References 
[1] Ziegler-Graham, K., MacKenzie, E.J., Ephraim, P.L., Travison, T.G., et al., EsƟmaƟng the 
Prevalence of Limb Loss in the United States: 2005 to 2050. Arch. Phys. Med. Rehabil. 2008, 
89, 422–429. 
[2] Whiteside, S., PracƟce Analysis of CerƟﬁed PracƟƟoners in the Disciplines of OrthoƟcs and 
ProstheƟcs. 2015. 
[3] Lower Limb ProstheƟc Workgroup Consensus Document. n.d. 
[4] Hafner, B.J., Smith, D.G., Diﬀerences in funcƟon and safety between medicare funcƟonal 
classiﬁcaƟon level-2 and -3 transfemoral amputees and inﬂuence of prostheƟc knee joint 
control. J. Rehabil. Res. Amp Dev. 2009, 46, 417–434. 
[5] Hafner, B.J., Willingham, L.L., Buell, N.C., Allyn, K.J., et al., EvaluaƟon of FuncƟon, 
Performance, and Preference as Transfemoral Amputees TransiƟon From Mechanical to 
Microprocessor Control of the ProstheƟc Knee. Arch. Phys. Med. Rehabil. 2007, 88, 207–
217. 
[6] Kaufman, K.R., Bernhardt, K.A., Symms, K., FuncƟonal assessment and saƟsfacƟon of 
transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-
controlled vs. non-microprocessor-controlled knees. Clin. Biomech. 2018, 58, 116–122. 
[7] Bullock, I.M., Zheng, J.Z., De La Rosa, S., Guertler, C., et al., Grasp frequency and usage in 
daily household and machine shop tasks. IEEE Trans. Haptics 2013, 6, 296–308. 
 

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IRB #: STU00217993-MODCR0002 Approved by NU IRB for use on or after 11/11/2024 through 11/10/2025.