Evaluation of an articulated passive ankle-foot prosthesis

Background: Current ankle prostheses for people with unilateral transtibial amputation (TTA) or transfemoral amputation (TFA) are unable to mimic able-bodied performance during daily activities. A new mechanical ankle-foot prosthesis was developed to further optimise the gait of people with a lower-limb amputation. This study aimed to evaluate the Talaris Demonstrator (TD) during daily activities by means of performance-related, physiological and subjective outcome measures.

Materials and methods: Forty-two participants completed a protocol assessing performance and functional mobility with their current prosthesis and the TD. The protocol comprised the L-test, 2 min of stair climbing, 2 min of inclined treadmill walking, 6 min of treadmill walking at 3 different speeds in consecutive blocks of 2 min, and a 3-m Backward Walk test (3mBWT). Heart rate was measured during each task, and oxygen uptake was collected during all tasks except for the L-test and 3mBWT. Time of execution was recorded on the L-test and 3mBWT, and the rate of perceived exertion (score = 6-20), fatigue and comfort (score = 0-100) were assessed after each task. Paired sample t-tests and Wilcoxon Signed-rank tests were performed to compare outcomes between prosthetic devices. Benjamini-Hochberg corrections were applied to control for multiple comparisons with a level of significance set at α = 0.05.

Results: Subjects with a TTA (N = 28) were faster with their current prosthesis compared to the TD on the L-test and 3mBWT (p = 0.005). In participants with a TFA (N = 14), we observed a tendency towards a higher heart rate during the L-test and towards increased comfort during inclined walking, with the TD compared to the participants' current prosthetic device (0.05 < p < 0.10). Further, no significant results were observed.

Conclusion: The Talaris Demonstrator is a novel state-of-the-art passive ankle-foot prosthesis for both people with a TTA and TFA. Subjective measures indicate the added value of this device, while overall task performance and intensity of effort do not differ between the Talaris Demonstrator and the current prosthesis. Further investigations unravelling both acute and more prolonged adaptations will be conducted to evaluate the TD more thoroughly.