Design and mechanical testing of an adjustable posterior leaf spring ankle-foot orthosis for patients with drop foot.

OBJECTIVES: This study aimed to design an adjustable posterior leaf spring (PLS) ankle-foot orthosis (AFO) with an affordable material in low-income countries and investigate the mechanical properties between an adjustable PLS AFO and a standard PLS AFO. STUDY DESIGN: Static and dynamic mechanical testing. METHODS: This study preliminarily tested a new adjustable PLS AFO against a standard PLS AFO. Each AFO design was tested with mechanical testing using an Instron 8801 universal testing machine. RESULTS: The stiffness value of the adjustable PLS AFO was greater than that of the standard PLS AFO during the static loading test. The energy dissipated ratios were lower in the adjustable PLS AFO than in the standard PLS AFO. After 110,000 cycles of fatigue testing, the distal rivet of the adjustable PLS AFO became loose, although the standard PLS AFO had no problem. CONCLUSIONS: The novel adjustable PLS AFO achieved noninferior mechanical properties except fatigue strength. The connecting area always initiated fatigue failure. It is suggested that this area must be prevented for stress concentration. As a preliminary study, this study is fundamental for future studies.

Validity and Reliability of Inertial Measurement Unit (IMU)-Derived 3D Joint Kinematics in Persons Wearing Transtibial Prosthesis.

BACKGROUND: A validity and reliability assessment of inertial measurement unit (IMU)-derived joint angular kinematics during walking is a necessary step for motion analysis in the lower extremity prosthesis user population. This study aimed to assess the accuracy and reliability of an inertial measurement unit (IMU) system compared to an optical motion capture (OMC) system in transtibial prosthesis (TTP) users. METHODS: Thirty TTP users were recruited and underwent simultaneous motion capture from IMU and OMC systems during walking. Reliability and validity were assessed using intra- and inter-subject variability with standard deviation (S.D.), average S.D., and intraclass correlation coefficient (ICC). RESULTS: The intra-subject S.D. for all rotations of the lower limb joints were less than 1° for both systems. The IMU system had a lower mean S.D. (o), as seen in inter-subject variability. The ICC revealed good to excellent agreement between the two systems for all sagittal kinematic parameters. CONCLUSION: All joint angular kinematic comparisons supported the IMU system's results as comparable to OMC. The IMU was capable of precise sagittal plane motion data and demonstrated validity and reliability to OMC. These findings evidence that when compared to OMC, an IMU system may serve well in evaluating the gait of lower limb prosthesis users.

Evaluation of an interphalangeal-joint prosthetic hand in trans-radial prosthesis users.

BACKGROUND: A body-powered functional and cosmetically appeasing hand with moving interphalangeal joints (IPJ-Hand) was created. Function and satisfaction with the IPJ-Hand, conventional hand (CH) and functional hook (FH) in trans-radial prosthesis users were evaluated. METHODS: Eight participants with trans-radial amputations were provided with three prosthetic hands and performed the Nine Hole Peg Test (NHPT), Brief Activity Measure of Upper Limb Amputees (BAM-ULA) and Quebec User Evaluation of Satisfaction with Assistive Technology QUEST). RESULTS: The data are shown as the median and interquartile range (IQR) due to skewed data distribution. Differences across hands were seen in NHPT with CH 57 (13.3), FH 49.5 (26.5), IPJ-H and 49 (14.8) seconds respectively. BAM-ULA, 10 (1.5), FH 10 (0.7), and IPJ-Hand 10 (1.7). QUEST scores, FH 28.5 (7.2) with the highest score, IPJ-Hand 26 (6.8), and lastly CH 25.5 (9.2). CONCLUSION: Individual participant results varied, with some participants performing better on the NHPT when using the IPJ-Hand when compared to the CH and FH. No differences between hands on the BAM-ULA were seen, and although no large differences in QUEST were observed, users performed best using IPJ-Hand.Key messagesAn interphalangeal joint prosthetic hand (IPJ-Hand) offers the similar function of a prosthetic hook, and the appearance of a conventional hand, but with improved dexterity.Minimal resources are needed to create the IPJ-Hand for prosthesis wearers.

High-Level Mobility of Trans-Tibial Prosthesis Users Wearing Commercial and sPace Energy-Storing Prosthetic Feet.

Outcomes of users provided with a commercial ESR Vari-Flex foot (Össur, Reykjavik, Iceland) and a locally designed sPace foot were investigated. Step activity with users' own prosthetic foot compared to the sPace foot was explored. METHODS: Eleven individuals with unilateral trans-tibial amputation participated and were provided with an sPace and Vari-Flex foot. Ten- and twenty-meter walk tests (10/20MWT) at comfortable and fast walking speeds (CWS/FWS), the two-minute walk test (2-MWT) and Comprehensive High-Level Activity Mobility Predictor (CHAMP) were administered. A subgroup was provided a pedometer to record their steps over a 7-day period in their own foot and later the sPace. RESULTS: The sPace foot performed well in a battery of high-level mobility outcome measures. On CHAMP, participants scored 16.94 ± 5.41 and 16.72 ± 6.09 with the sPace and Vari-Flex feet, respectively. Subgroup testing of step activity showed 4490 ± 3444 steps in users' own feet and 3115 ± 1967 in the sPace foot, p = 0.176. CONCLUSIONS: Participants using the sPace foot were capable of performing walking, high-level mobility and activity outcome measures.

Assessment of Socket Pressure during Walking in Rapid Fit Prosthetic Sockets.

(1) Background: A sustainable casting system that combines the use of a polystyrene bag, a prosthetic liner and a vacuum system was developed to reduce fabrication time while maintaining comfort for the trans-tibial prosthesis user. (2) Methods: Eight prosthetists (28.7 ± 8.25 years old) fit ten trans-tibial prosthesis wearers (46 ± 12.4 years old) with two types of total surface bearing (TSB) prostheses; a polystyrene bead (PS) prosthesis and a plaster of paris (POP) prosthesis. Duration of casting and combined mean peak pressure was measured at six locations on the residual limb using Force Sensing Resistors (FSR). A pressure uniformity score (%) was determined. Socket Comfort Scale (SCS) was also measured. (3) Results: Duration of casting for the POP method was 64.8 ± 9.53 min and 7.8 ± 2 min for the PS method, (p = 0.006). Pressure uniformity in the POP prosthesis was 79.3 ± 6.54 and 81.7 ± 5.83 in the PS prosthesis (p = 0.027). SCS in both prosthesis types were equivalent. (4) Conclusion: A rapid fit PS prosthesis was developed, with significantly shorter duration than the traditional POP method. Socket pressure uniformity was confirmed and improved in the PS method. Socket comfort was equal between the two prothesis types.

Sustainable, affordable and functional: reimagining prosthetic liners in resource limited environments.

PURPOSE: The purpose of this study was to evaluate function and performance of unilateral trans-tibial prosthesis users wearing an affordable liner in three types of socket designs. METHODS: Five unilateral trans-tibial amputees participated, were provided an Affordable Ethyl-Vinyl-Acetate Roll-On liner (AERO) roll-on liner with patella tendon bearing (PTB) prosthesis, PE-Lite liner with PTB prosthesis, and an (AERO) liner with total-surface bearing (TSB) prosthesis. A battery of outcome measures; step-counts, socket comfort score (SCS), orthotics prosthetics user survey (OPUS) and socket pressure measurement during walking were administered. RESULTS: Comparisons of step-counts indicated that PTB-AERO (3604 ± 815) was not significantly different than PTB-PE-Lite (3386 ± 942). Mean SCS was 9.2 ± .83 and 7.2 ± 2.1 for PTB-AERO and PTB-PE-Lite. A 6.6% decrease in mean peak pressure was observed between PTB-PE-Lite and TSB-AERO, and 3.2% difference between PTB-PE-Lite and PTB-AERO. CONCLUSION: An affordable ($20 USD) and sustainably fabricated prosthesis liner was created and evaluated in trans-tibial prosthesis users. These initial results garner preliminary support for use of the AERO prosthetic liner and continued research.Implications for rehabilitationLower limb prosthetics in less-resourced settings can leverage locally sourced and affordable materials to fabricate roll-on liners for use in modern prosthetic sockets.The cost of the AERO liner is markedly lower than current standard of care gel liners, yet still facilitates use of current prosthetic sockets.

Correlates of Balance and Aerobic Indices in Lower-Limb Prostheses Users on Arm Crank Exercise.

BACKGROUND: The HUMAC Balance System (HBS) offers valid measurement of balance, and the arm crank exercise test (ACE) is a valid measure of physiological capacity. Neither have been used to evaluate associations between balance and physiological capacity in lower-limb amputees. METHODS: Thirty-five participants with lower-limb amputations were recruited. Standing balance (center of pressure) was evaluated during eyes opened (EO) and eyes closed (EC) conditions using the HBS. Participants performed ACE graded exercise testing (GXT) to evaluate aerobic capacity. Spearman's rho was used to identify relationships between variables. Cut-points for three groups were generated for time on ACE. Mann-Whitney U tests were used to explore significant differences in variables of balance and ACE between low and high performers. RESULTS: Relationships between variables of eyes open displacement (EOD), eyes open velocity (EOV), eyes closed displacement (ECD), and eyes closed velocity (ECV) were significant (p < 0.05), and high performers with EO also performed best with EC. Longer exercise times were significantly associated with increased HRpeak, VO2peak, VEpeak, and RERpeak (p < 0.05). HRpeak (143.0 ± 30.6 b/min), VO2peak (22.7 ± 7.9 and 10.6 ± 4.7 mL/kg/min), VEpeak (80.2 ± 22.2 and 33.2 ± 12.7 L/min), and RERpeak (1.26 ± 0.08 and 1.13 ± 0.11) were significantly greater in high performers than low performers, respectively (p < 0.05). There was no significant association among VO2peak and any balance task variables; however, there were significant associations between some balance and physiological variables. CONCLUSIONS: Findings differentiated high and low performers; however, participants were still well below able-bodied norms of physical capacity. Training to mitigate deconditioning is suggested.

Quantifying Step Count and Oxygen Consumption with Portable Technology during the 2-Min Walk Test in People with Lower Limb Amputation.

Step counts and oxygen consumption have yet to be reported during the 2-min walk test (2MWT) test in persons with lower-limb amputations (LLA). The purpose of this study was to determine step counts and oxygen consumption during the 2MWT in LLA. Thirty-five men and women walked for two minutes as quickly as possible while wearing activity monitors (ActiGraph Link on the wrist (LW) and ankle (LA), Garmin vivofit®3 on the wrist (VW) and ankle (VA), and a modus StepWatch on the ankle (SA), and a portable oxygen analyzer. The StepWatch on the ankle (SA) and the vivofit3 on the wrist (VW) had the least error and best accuracy of the activity monitors studied. While there were no significant differences in distance walked, oxygen consumption (VO2) or heart rate (HR) between sexes or level of amputation (p > 0.05), females took significantly more steps than males (p = 0.034), and those with unilateral transfemoral amputations took significantly fewer steps than those with unilateral transtibial amputations (p = 0.023). The VW and SA provided the most accurate step counts among the activity monitors and were not significantly different than hand counts. Oxygen consumption for all participants during the 2MWT was 8.9 ± 2.9 mL/kg/min, which is lower than moderate-intensity activity. While some may argue that steady-state activity has not yet been reached in the 2MWT, it may also be possible participants are not walking as fast as they can, thereby misclassifying their performance to a lower standard.

A Comparison of the Conventional PiG Marker Method Versus a Cluster-Based Model when recording Gait Kinematics in Trans-Tibial Prosthesis Users and the Implications for Future IMU Gait Analysis.

Validation testing is a necessary step for inertial measurement unit (IMU) motion analysis for research and clinical use. Optical tracking systems utilize marker models which must be precise in measurement and mitigate skin artifacts. Prosthesis wearers present challenges to optical tracking marker model choice. Seven participants were recruited and underwent simultaneous motion capture from two marker sets; Plug in Gait (PiG) and the Strathclyde Cluster Model (SCM). Variability of joint kinematics within and between subjects was evaluated. Variability was higher for PiG than SCM for all parameters. The within-subjects variability as reported by the average standard deviation (SD), was below 5.6° for all rotations of the hip on the prosthesis side for all participants for both methods, with an average of 2.1° for PiG and 2.5° for SCM. Statistically significant differences in joint parameters caused by a change in the protocol were evident in the sagittal plane (p < 0.05) on the amputated side. Trans-tibial gait analysis was best achieved by use of the SCM. The SCM protocol appeared to provide kinematic measurements with a smaller variability than that of the PiG. Validation studies for prosthesis wearer populations must reconsider the marker protocol for gold standard comparisons with IMUs.

The validity and accuracy of wrist-worn activity monitors in lower-limb prosthesis users.

Purpose: To investigate the accuracy of consumer-grade wrist-worn activity monitors during over ground walking in persons using lower-limb prosthetics.Method: Thirty-two participants using lower-limb prosthetics (age = 49.7 ± 14.0 yrs, height = 176.1 ± 11.6 cm, weight = 87.8 ± 21.1 kg) were fitted with a Polar Loop, Fitbit Flex, MOVEBAND, Garmin Vivofit, and a Fitbit Charge on the right and left wrists as well as an Omron HJ-113 pedometer on the right and left hip, then walked 140 m at a self-selected pace on an indoor flat surface.Results: There were no significant differences between any of the respective right and left monitors, p > 0.05. When comparing step counts with actual step counts, Polar Loop (p = 0.001), Fitbit Flex (p = 0.001), and MOVEBAND (p = 0.001) were significantly lower than actual step counts. No significant differences existed between the remaining monitors and actual step counts (p > 0.05). Omron incurred the least error (0.6%), followed by Garmin Vivofit (1.3%) and Fitbit Charge (3.6%), with greatest error in the MOVEBAND (21.4%) and Polar Loop (13.1%). Bland-Altman plots suggest Garmin Vivofit to have the least error along with tightest agreement among the wrist-worn activity monitorsConclusion: When considering the use of consumer-grade wrist-worn activity monitors for assessing step counts in persons using lower-limb prostheses, the Garmin Vivofit seems to be the best option followed by Fitbit Charge.Implications for rehabilitationThis study shows that despite potential of altered gait, some consumer-grade activity monitors can track over ground walking quite well.Clinicians and researchers can use these devices to track activity and prosthetic compliance in their patients.

The reversible adjustable coupling: A lightweight and low-cost alignment component for the lower limb prosthesis.

BACKGROUND: The alignment of the lower limb prosthesis is an integral part of the prosthetic fitting. A properly aligned prosthesis contributes to optimal gait and overall function of the patient. The current offering of alignment componentry is expensive for low-income countries. The purpose of this study was to develop a lightweight and low-cost alignment coupler for the lower limb prosthesis. METHODS: An alignment coupler called the reversible adjustable coupling was designed and manufactured. Measurements of total anterior/posterior and medial/lateral and rotation in prostheses were recorded and mechanical testing performed. Swiftness and difficulty of use was also recorded. RESULTS: The reversible adjustable coupling permitted acceptable ranges of anterior/posterior and medial/lateral translation and 30° of internal and external rotation of prosthetic componentry. Repetitive loading of the coupling at a speed of 1 Hz under 1.28 kN load for 2000 cycles was successful, as were static and strength tests. DISCUSSION: The coupler provided acceptable ranges of anterior/posterior and medial/lateral and rotation adjustment and is acceptable for potential use in the alignment of both exoskeletal and endoskeletal prosthesis. The final weight of the component was 166 g and cost of $55.00 USD is affordable for low-income countries for use in clinical and educational settings.

The development and testing of a modified natural rubber CR solid ankle-cushion heel prosthetic foot for developing countries.

BACKGROUND: Durable and locally fabricated prosthetic feet are important for developing countries. Modifications to the current CR solid ankle-cushion heel prosthetic foot could enhance current foot characteristics and reduce costs. The goal of this project was to modify the keel and rubber outer foot shell to enhance features and reduce costs of the current CR solid ankle-cushion heel offering. METHODS: The prosthetic foot was designed, fabricated and then tested mechanically for strain and displacement in a cyclic testing machine according to a component of the ISO-10328 testing protocol. Dynamic cyclic testing of both forefoot and heel portions of the foot was conducted. FINDINGS: Dynamic mechanical cyclic testing of the forefoot and heel at 1.28 kN for two million cycles at a rate of 1 Hz was successfully achieved. The final cost of producing the foot was roughly $16 USD. Limitations include the inability to perform the full battery of ISO-10328 foot testing, UV testing and a limitation to laboratory testing. Clinical studies examining practical application of the modified foot should be conducted.