Clinical investigation of the interface pressure in the trans-tibial socket with Dermo and Seal-In X5 liner during walking and their effect on patient satisfaction

BACKGROUND: The interface pressure between the residual limb and prosthetic socket has a significant effect on an amputee's satisfaction and comfort. Liners provide a comfortable interface by adding a soft cushion between the residual limb and the socket. The Dermo and the Seal-In X5 liner are two new interface systems and, due to their relative infancy, very little are known about their effect on patient satisfaction. The aim of this study was to compare the interface pressure with these two liners and their effect on patient satisfaction. METHODS: Nine unilateral transtibial amputees participated in the study. Two prostheses were fabricated for each amputee, one with the Seal-In liner and one with the Dermo liner. Interface pressure was measured at the anterior, posterior, medial and lateral regions during walking on the level ground. Each subject filled in a Prosthetic Evaluation Questionnaire (PEQ) regarding the satisfaction with the two liners. Findings The mean peak pressures with the Seal-In liner was 34.0% higher at the anterior, 24.0% higher at the posterior and 7.0% higher at the medial regions of the socket (P=0.008, P=0.046, P=0.025) than it was with the Dermo Liner. There were no significant differences in the mean peak pressures between the two liners at the lateral regions. In addition, significant difference was found between the two liners both for satisfaction and problems (P<0.05). Interpretation There was less interface pressure between the socket and the residual limb with the Dermo liner. The results indicated that the Dermo liner provides more comfort in the socket than the Seal-In liner.     

Transtibial prosthetic socket pistoning: static evaluation of Seal-In(®) X5 and Dermo(®) Liner using motion analysis system

Background

The method of attachment of prosthesis to the residual limb (suspension) and socket fitting is a critical issue in the process of providing an amputee with prosthesis. Different suspension methods try to minimize the pistoning movement inside the socket. The Seal-In^® X5 and Dermo^® Liner by Ossur are new suspension liners that intend to reduce pistoning between the socket and liner. Since the effects of these new liners on suspension are unclear, the objective of this study was to compare the pistoning effect of Seal-In^® X5 and Dermo^® Liner by using Vicon Motion System.

Methods

Six transtibial amputees, using both the Iceross Seal-In^® X5 and the Iceross Dermo^® Liner, participated in the study. The vertical displacement (pistoning) was measured between the liner and socket in single limb support on the prosthetic limb (full-weight bearing), double limb support (semi-weight bearing), and non-weight bearing on the prosthetic limb, and also under three static vertical loading conditions (30 N, 60 N, and 90 N).

Findings

The results demonstrated that the pistoning within the socket when Seal-In^® X5 was used, decreased by 71% in comparison to the Iceross Dermo^® Liner. In addition, a significant difference between the two liners under different static conditions was found (p < 0.05).

Interpretation

Participants needed to put in extra effort for donning and doffing the prosthesis with Seal-In^® X5; however, this type of liner provided less pistoning. The new approach that uses the motion analysis system in this study might be an alternative for measuring the pistoning effect in the prosthetic socket.     

Interface pressure in transtibial socket during ascent and descent on stairs and its effect on patient satisfaction

BackgroundTranstibial amputees encounter stairs and steps during their daily activities. The excessive pressure between residual limb/socket may reduce the walking capability of transtibial prosthetic users during ascent and descent on stairs. The purposes of the research were to evaluate the interface pressure between Dermo (shuttle lock) and Seal-In X5 (prosthetic valve) interface systems during stair ascent and descent, and to determine their satisfaction effects on users.MethodsTen amputees with unilateral transtibial amputation participated in the study. Interface pressure was recorded with F-socket transducer (9811E) during stair ascent and descent at self-selected speed. Each participant filled in a questionnaire about satisfaction and problems encountered with the use of the two interface systems.FindingsThe resultant mean peak pressure (kPa) was significantly lower for the Dermo interface system compared to that of the Seal-In X5 interface system at the anterior, posterior and medial regions during stair ascent (63.14 vs. 80.14, 63.14 vs. 90.44, 49.21 vs. 66.04, respectively) and descent (67.11 vs. 80.41, 64.12 vs. 88.24, 47.33 vs. 65.11, respectively). Significant statistical difference existed between the two interface systems in terms of satisfaction and problems encountered (P < 0.05).InterpretationThe Dermo interface system caused less pressure within the prosthetic socket compared to the Seal-In X5 interface system during stair negotiation. The qualitative survey also showed that the prosthesis users experienced fewer problems and increased satisfaction with the Dermo interface system.     

A noncontact sensor for measurement of distal residual-limb position during walking

A simple noncontact device was implemented for measuring the position of the distal residual limb relative to the prosthetic socket during ambulation. The device was a small and lightweight photoelectric sensor positioned within a frame mounted immediately beneath the socket. Calibration tests showed that the sensor had a displacement range of 60.0 mm. The root-mean-square error for all sources of error considered (different reflective surfaces, peak-to-peak signal noise, drift, nonlinearity, different surface tilt angles, surface curvature, and wetness [simulating sweating]) was <1.95% full-scale output. We used the sensor in a preliminary study on a unilateral, transtibial amputee with diabetes to assess pistoning during ambulation. Results showed an average 41.7 mm proximal displacement during swing phase relative to stance phase. When the subject was walking on a flat surface, pistoning was significantly less (p = 0.000) with a supracondylar strap compared with no supracondylar strap, although the difference was not substantial (0.8 mm). A 5 min rest period caused the limb to displace proximally in the socket approximately 4.8 mm during subsequent walking trials, possibly reflecting limb enlargement and thus a more proximal position in the socket after the rest period. The device can potentially be used in prosthetics research for evaluating clinical features that may affect limb position and pistoning and thus fit.     

Effect of prosthetic gel liner thickness on gait biomechanics and pressure distribution within the transtibial socket

Prosthetic gel liners are often prescribed for persons with lower-limb amputations to make the prosthetic socket more comfortable. However, their effects on residual limb pressures and gait characteristics have not been thoroughly explored. This study investigated the effects of gel liner thickness on peak socket pressures and gait patterns of persons with unilateral transtibial amputations. Pressure and quantitative gait data were acquired while subjects walked on liners of two different uniform thicknesses. Fibular head peak pressures were reduced (p = 0.04) with the thicker liner by an average of 26 +/- 21%, while the vertical ground reaction force (GRF) loading peak increased 3 +/- 3% (p = 0.02). Most subjects perceived increased comfort within the prosthetic socket with the thicker liner, which may be associated with the reduced fibular head peak pressures. Additionally, while the thicker liner presumably increased comfort by providing a more compliant limb-socket interface, the higher compliance may have reduced force and vibration feedback to the residual limb and contributed to the larger vertical GRF loading peaks. We conclude that determining optimal gel liner thickness for a particular individual will require further investigations to better identify and understand the compromises that occur between user perception, residual-limb pressure distribution, and gait biomechanics.     

Sprint kinematics of athletes with lower-limb amputations.

OBJECTIVE: To determine and compare the kinematics of the sound and prosthetic limb in five of the world's best unilateral amputee sprinters. SUBJECTS: Five men, all unilateral lower-limb amputee (one transfemoral, four transtibial) athletes. The individual with transfemoral amputation used a Endolite Hi-activity prosthesis incorporating a CaTech hydraulic swing and stance control unit, a Flex-Foot Modular III, and an ischial containment total contact socket. Those with transtibial amputations used prostheses incorporating a Flex-Foot Modular III and patellar tendon-bearing socket, with silicone sheath liner (Iceross) and lanyard suspension. DESIGN: Case series. Subjects were videotaped sprinting through a performance area. Sagittal plane lower-limb kinematics derived from manual digitization (at 50 Hz) of the video were determined for three sprint trials of the prosthetic and sound limb. Hip, knee, and ankle kinematics of each subject's sound and prosthetic limb were compared to highlight kinematic alterations resulting from the use of individual prostheses. Comparisons were also made with mean data from five able-bodied men who had similar sprinting ability. RESULTS: Sound limb hip and knee kinematics in all subjects with amputation were comparable to those in able-bodied subjects. The prosthetic knee of the transfemoral amputee athlete fully extended early in swing and remained so through stance. In the transtibial amputee athletes, as in able-bodied subjects, a pattern of stance flexion-extension was evident for both limbs. During stance, prosthetic ankle angles of the transtibial amputee subjects were similar to those of the sound side and those of able-bodied subjects. CONCLUSION: Prosthetic limb kinematics in transtibial amputee subjects were similar to those for the sound limb, and individuals achieved an "up-on-the-toes" gait typical of able-bodied sprinting. Kinematics for the prosthetic limb of the transfemoral amputee subject were more typical of those seen for walking. This resulted in a sprinting gait with large kinematic asymmetries between contralateral limbs.     

Hygiene problems of residual limb and silicone liners in transtibial amputees wearing the total surface bearing socket

OBJECTIVE: To determine whether washing the residual limb and silicone liner reduces the associated skin problems in transtibial amputees who wear a total surface bearing (TSB) socket. DESIGN: Case series. SETTING: General community. PATIENTS: Eighty-three transtibial amputees (65 men, 18 women; mean age, 53.4 yr) in western Japan who used or had used a TSB socket with a silicone liner in the previous 5 years. INTERVENTION: Participants took a self-administered questionnaire that included items concerning their personal profile, daily life activities, period of TSB use (yr), hours of TSB use daily, washing frequency of the residual limb and silicone liner, the method of washing, and any associated hygiene problems. MAIN OUTCOME MEASURES: Logistic regression analysis was applied to examine factors related to hygiene problems. Predicted values include hygiene problems (perspiration, eruptions, itching, odor) and explanatory values include TSB use, daily life activity, and washing of limb and prosthetic. RESULTS: Fifty-five subjects washed the residual limb, and 44 subjects washed the silicone liner every day. Itching, perspiration, eruption, and odor were frequent hygiene problems. Perspiration was noted less by women, eruption more by older subjects, and itching and odor more by younger subjects. Washing the silicone liner every day was associated with fewer reports of skin eruption. CONCLUSION: Keeping the residual limb and silicone liner clean is important to reduce skin problems, but hygiene problems of the residual limb and silicone liner still remain to be resolved.     

Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume

Klute GK, Berge JS, Biggs W, Pongnumkul S, Popovic Z, Curless B. Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume.

Objective

To investigate the effect of a vacuum-assisted socket suspension system as compared with pin suspension on lower extremity amputees.

Design

Randomized crossover with 3-week acclimation.

Setting

Household, community, and laboratory environments.

Participants

Unilateral, transtibial amputees (N=20 enrolled, N=5 completed).

Interventions

(1) Total surface–bearing socket with a vacuum-assisted suspension system (VASS), and (2) modified patellar tendon–bearing socket with a pin lock suspension system.

Main Outcome Measures

Activity level, residual limb volume before and after a 30-minute treadmill walk, residual limb pistoning, and Prosthesis Evaluation Questionnaire.

Results

Activity levels were significantly lower while wearing the vacuum-assisted socket suspension system than the pin suspension (P=.0056; 38,000±9,000 steps per 2wk vs 73,000±18,000 steps per 2wk, respectively). Residual limb pistoning was significantly less while wearing the vacuum-assisted socket suspension system than the pin suspension (P=.0021; 1±3mm vs 6±4mm, respectively). Treadmill walking had no effect on residual limb volume. In general, participants ranked their residual limb health higher, were less frustrated, and claimed it was easier to ambulate while wearing a pin suspension compared with the VASS.

Conclusions

The VASS resulted in a better fitting socket as measured by limb movement relative to the prosthetic socket (pistoning), although the clinical relevance of the small but statistically significant difference is difficult to discern. Treadmill walking had no effect, suggesting that a skilled prosthetist can control for daily limb volume fluctuations by using conventional, nonvacuum systems. Participants took approximately half as many steps while wearing the VASS which, when coupled with their subjective responses, suggests a preference for the pin suspension system.     

Improper use of a transtibial prosthesis silicone liner causing pressure ulceration

We present the previously unreported hazard of creating pressure ulceration in a susceptible host by the improper use of a silicone prosthetic liner. An 80-yr-old man sustained a recent transtibial amputation for peripheral vascular disease. His comorbidities included vascular cognitive impairment, type 2 diabetes mellitus, coronary artery disease, anemia of chronic disease, postherpetic neuralgia, and pruritus of uncertain origin. When not using his transtibial prosthesis, he found his 1.5-mm thick silicone liner (ICEROSS) more comfortable to wear than his stump shrinker and thermoplastic protector. Moreover, he repeatedly wore his liner rolled partway down his stump to allow him to scratch pruritic skin. A horizontal, linear, stage 2 ulcer developed on the residual limb under the upper edge of the rolled liner. The ulcer required >3 mos to heal. This case illustrates the importance of candidate selection for roll-on liners, proper patient and professional training, and optimal management of patient comorbidities.     

Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance

BackgroundSmall intermittent adjustments of socket size using adjustable sockets may be a means for people with transtibial amputation to better maintain residual limb fluid volume and limb position while using a prosthesis.MethodsSocket size, limb fluid volume, and distance from the limb to the socket, termed “sensed distance,” were recorded while participants with transtibial amputation walked on a treadmill wearing a motor-driven, cabled-panel, adjustable socket. Researchers made frequent socket size adjustments using a mobile phone app to identify participants' acceptable socket size range. Limb fluid volume and sensed distance were then monitored as incremental adjustments were made to the socket.FindingsProsthesis users in this study (n = 10) accepted socket sizes between −5% and +5% of their neutral socket volume. There was a rapid increase in limb fluid volume and sensed distance upon socket enlargement, and a rapid decrease upon reduction. Subsequently, there were gradual changes in fluid volume and sensed distance. While visually monitoring limb fluid volume data in real time, researchers were able to adjust socket size to maintain consistent limb fluid volume within a −0.7% to +0.9% volume change for 24 min.InterpretationParticipant residual limbs compensated to socket size adjustment. Using socket-mounted sensors to monitor limb-socket mechanics, an automatic adjustable socket that maintains limb fluid volume may be possible and may improve socket fit in instances where fit deteriorates during use.     

An experimental study of the interface pressure profile during level walking of a new suspension system for lower limb amputees

Background

Different suspension systems that are used within prosthetic devices may alter the distribution of pressure inside the prosthetic socket in lower limb amputees. This study aimed to compare the interface pressure of a new magnetic suspension system with the pin/lock and Seal-In suspension systems.

Methods

Twelve unilateral transtibial amputees participated in the study. The subjects walked on a level walkway at a self-selected speed. The resultant peak pressure with the three different suspension systems was recorded using F-socket transducers.

Findings

There were significant statistical differences between the three studied suspension systems. Pair-wise analyses revealed that the mean peak pressure (kPa) was lower with the magnetic system than it was with the pin/lock system over the anterior and posterior aspects during one gait cycle (89.89 vs. 79.26 and 47.22 vs. 26.01, respectively). Overall, the average peak pressure values were higher with the Seal-In system than they were with the new magnetic lock and pin/lock system.

Interpretation

The new magnetic system might reduce the pressure within the prosthetic socket in comparison to the pin/lock and Seal-In system during one gait cycle. This is particularly important during the swing phase of gait and may reduce the pain and discomfort at the distal residual limb in comparison to the pin/lock system.     

Interface pressures during ambulation using suction and vacuum-assisted prosthetic sockets

Interface pressures were measured during ambulation with a normal total-surface weight-bearing suction socket and a vacuum-assisted socket. The vacuum-assisted socket has been shown to eliminate daily volume loss. Urethane liners were instrumented with five force-sensing resistors to measure positive pressures and one air pressure sensor at the distal end of the liner to document negative pressures. Nine unilateral transtibial amputees participated in the study. The vacuum-assisted socket created significantly lower positive-pressure impulse (42.8, 39.6 kPa x s) and peak pressures (83.5, 80.0 kPa) during the stance phase. The pressure impulse (-10.5, -13.3 kPa x s), average (-21.2, -26.5 kPa), and peak (-28.5, -36.3 kPa) negative pressures during swing phase were significantly greater in magnitude with the vacuum-assisted socket. We believe that lower positive pressures seen during stance using the vacuum-assisted socket reduces the fluid forced out and greater negative pressures seen during swing increases the amount of fluid drawn into the limb, thereby preventing volume loss.     

Temperature measurement and control system for transtibial prostheses: Single subject clinical evaluation

The snug fit of a prosthetic socket over the residual limb can disturb thermal balance and put skin integrity in jeopardy by providing an unpleasant and infectious environment. The prototype of a temperature measurement and control (TM&C) system was previously introduced to resolve thermal problems related to prostheses. This study evaluates its clinical application in a setting with reversal, single subject design. The TM&C system was installed on a fabricated prosthetic socket of a man with unilateral transtibial amputation. Skin temperature of the residual limb without prosthesis at baseline and with prosthesis during rest and walking was evaluated. The thermal sense and thermal comfort of the participant were also evaluated. The results showed different skin temperature around the residual limb with a temperature decrease tendency from proximal to distal. The TM&C system decreased skin temperature rise after prosthesis wearing. The same situation occurred during walking, but the thermal power of the TM&C system was insufficient to overcome heat build-up in some regions of the residual limb. The participant reported no significant change of thermal sense and thermal comfort. Further investigations are warranted to examine thermography pattern of the residual limb, thermal sense, and thermal comfort in people with amputation.     

Consistency, precision, and accuracy of optical and electromagnetic shape-capturing systems for digital measurement of residual-limb anthropometrics of persons with transtibial amputation

Computer-aided design (CAD) and computer-aided manufacturing systems have been adapted for specific use in prosthetics, providing practitioners with a means to digitally capture the shape of a patient's limb, modify the socket model using software, and automatically manufacture either a positive model to be used in the fabrication of a socket or the socket itself. The digital shape captured is a three-dimensional (3-D) model from which standard anthropometric measures can be easily obtained. This study recorded six common anthropometric dimensions from CAD shape files of three foam positive models of the residual limbs of persons with transtibial amputations. Two systems were used to obtain 3-D models of the residual limb, a noncontact optical system and a contact-based electromagnetic field system, and both experienced practitioners and prosthetics students conducted measurements. Measurements were consistent; the mean range (difference of maximum and minimum) across all measurements was 0.96 cm. Both systems provided similar results, and both groups used the systems consistently. Students were slightly more consistent than practitioners but not to a clinically significant degree. Results also compared favorably with traditional measurement, with differences versus hand measurements about 5 mm. These results suggest the routine use of digital shape capture for collection of patient volume information.     

Transtibial prosthesis suspension systems: Systematic review of literature

Background

Today a number of prosthetic suspension systems are available for transtibial amputees. Consideration of an appropriate suspension system can ensure that amputee's functional needs are satisfied. The higher the insight to suspension systems, the easier would be the selection for prosthetists. This review attempted to find scientific evidence pertaining to various transtibial suspension systems to provide selection criteria for clinicians.

Methods

Databases of PubMed, Web of Science, and ScienceDirect were explored to find related articles. Search terms were as follows: “Transtibial prosthesis (32), prosthetic suspension (48), lower limb prosthesis (54), below-knee prosthesis (58), prosthetic liner (20), transtibial (193), and prosthetic socket (111)”. Two reviewers separately examined the papers. Study design (case series of five or more subjects, retrospective or prospective), research instrument, sampling method, outcome measures and protocols were reviewed.

Findings

Based on the selection criteria, 22 articles (15 prospective studies, and 7 surveys) remained. Sweat control was found to be a major concern with the available suspension liners. Donning and doffing procedures for soft liners are also problematic for some users, particularly those with upper limb weakness. Moreover, the total surface bearing (TSB) socket with pin/lock system is favored by the majority of amputees.

Interpretation

In summary, no clinical evidence is available to suggest what kind of suspension system could have an influential effect as a “standard” system for all transtibial amputees. However, among various suspension systems for transtibial amputees, the Iceross system was favored by the majority of users in terms of function and comfort.     

Satisfaction and Problems Experienced With Transfemoral Suspension Systems: A Comparison Between Common Suction Socket and Seal-In Liner

Objective

To compare a seal-in liner with the common suction socket with regards to patient satisfaction and problems experienced with the prosthesis.

Design

Retrospective survey.

Setting

A medical and engineering research center and a department of biomechanical engineering.

Participants

Men (N=90) with traumatic transfemoral amputation who used both suspension systems participated in the study.

Intervention

Two prosthetic suspension systems: a seal-in liner and common suction socket.

Main Outcome Measures

Two questionnaires were completed by each subject to evaluate their satisfaction and problems experienced with the 2 suspension systems. Satisfaction and problems with the prosthetic suspension systems were analyzed in terms of fitting, donning and doffing, sitting, walking, stair negotiation, appearance, sweating, wounds, pain, irritation, pistoning, edema, smell, sound, and durability.

Results

The study revealed that the respondents were more satisfied with a seal-in liner with regards to fitting, sitting, and donning and doffing. Overall satisfaction increased with the use of a seal-in liner compared with the suction socket (P<.05). However, satisfaction with the prosthesis showed no significant differences in terms of walking (flat and uneven surfaces), appearance, and stair negotiation. Furthermore, problems experienced differed significantly between the 2 suspension systems (P<.05). Sweating, wounds, pain, irritation, pistoning, edema, smell, and sound were less problematic with the use of a seal-in liner, whereas durability was significantly better with the suction socket.

Conclusions

The results of the survey suggest that satisfaction and problems with prosthetic suspension in persons with transfemoral amputation can be improved with a seal-in liner compared with the suction socket, provided that the durability of the liner is enhanced.     

Biomechanical adaptations of transtibial amputee sprinting in athletes using dedicated prostheses

OBJECTIVE: To determine the biomechanical adaptations of the prosthetic and sound limbs in two of the world's best transtibial amputee athletes whilst sprinting. DESIGN: Case study design, repeated measures. BACKGROUND: Using dedicated sprint prostheses transtibial amputees have run the 100 m in a little over 11 s. Lower-limb biomechanics when using such prostheses have not previously been investigated. METHODS: Moments, muscle powers and the mechanical work done at the joints of the prosthetic and sound limbs were calculated as subjects performed repeated maximal sprint trials using a Sprint Flex or Cheetah prosthesis. RESULTS: An increased hip extension moment on the prosthetic limb, with an accompanying increase in the amount of concentric work done, was the most notable adaptation in Subject 1 using either prosthesis. In Subject 2, an increased extension moment at the residual knee, and an accompanying increase in the amount of total work done, was the most notable adaptation using either prosthesis. This later adaptation was also evident in Subject 1 when using his Sprint Flex prosthesis. CONCLUSIONS: Increased hip work on the prosthetic limb has previously been shown to be the major compensatory mechanism that allow transtibial amputees to run. The increased work found at the residual knee, suggests that the two amputee sprinters used an additional compensatory mechanism. RELEVANCE: These findings provide an insight into the biomechanical adaptations that allow a transtibial amputee to attain the speeds achieved when sprinting.     

Individual responses to alignment perturbations in socket reaction moments while walking in transtibial prostheses

Background

The alignment of transtibial prostheses has a systematic effect on the mean socket reaction moments in amputees. However, understanding their individual differences in response to alignment perturbations is also important for prosthetists to fully utilize the socket reaction moments for dynamic alignment in each unique patient. The aim of this study was to investigate individual responses to alignment perturbations in transtibial prostheses with solid-ankle-cushion-heel feet.

Methods

A custom instrumented prosthesis alignment component was used to measure the socket reaction moments while walking in 11 amputees with transtibial prostheses under 17 alignment conditions, including 3° and 6° of flexion, extension, abduction, and adduction of the socket, 5 mm and 10 mm of anterior, posterior, lateral, and medial translation of the socket, and an initial baseline alignment. Coronal moments at 30% of stance and maximum sagittal moments were extracted for comparisons from each amputee.

Findings

In the coronal plane, varus moment at 30% of stance was generally reduced by adduction or medial translation of the socket in all the amputees. In the sagittal plane, extension moment was generally increased by posterior translation or flexion of the socket; however, this was not necessarily the case for all the amputees.

Interpretations

Individual responses to alignment perturbations are not always consistent, and prosthetists would need to be aware of this variance when addressing individual socket reaction moments during dynamic alignment in clinical setting.     

Effects of alignment on interface pressure for transtibial amputee during walking

Purpose. To assess the mechanical behaviour at interface for unilateral transtibial amputees during walking when the prosthesis is misaligned, since studies examining interface pressure between residual limb and prosthetic socket have been restricted to unsupported stance and natural gait.

Method. One male subject with transtibial amputation volunteers for the study. Interface pressures over five sites are measured under three sagittal alignment settings. MP (mean peak interface pressure), TP₉₀₊ (time in which pressure exceeded 90% of peak pressure) and TPI₉₀₊ (time-pressure integral at the period of sustained sub-maximal load) are discussed for each alignment setting.

Results. Compared with optimal alignment, the trend of interface pressure, the mean peak pressure do not change much, but the duration of sub-maximal pressure changes remarkably, except that at the patellar tendon, and finally the TPI₉₀₊ changes considerably with different alignment settings.

Conclusions. The results offer the clinician and paramedical staff further insight in residual limb/socket interface mechanics in the transtibial amputation patients and provide potentially useful information for socket design and prosthesis fitting.     

Shape and volume change in the transtibial residuum over the short term: preliminary investigation of six subjects

A preliminary investigation was conducted to characterize the magnitude and distribution of volume change in transtibial residua at two time intervals: upon prosthesis removal and at 2 week intervals. Six adult male unilateral transtibial amputee subjects, between 0.75 and 40.0 years since amputation, were imaged 10 times over a 35-minute interval with a custom residual limb optical scanner. Volume changes and shape changes over time were assessed. Measurements were repeated 2 weeks later. Volume increase on socket removal for the six subjects ranged from 2.4% to 10.9% (median 6.0% +/- standard deviation 3.6%). Rate of volume increase was highest immediately upon socket removal and decreased with time (five subjects). In four subjects, 95% of the volume increase was reached within 8 minutes. No consistent proximal-to-distal differences were detected in limb cross-sectional area change over time. Limb volume differences 2 weeks apart ranged from -2.0% to 12.6% (0.6% +/- 5.5%) and were less in magnitude than those within a session over the 35-minute interval (five subjects). Multiple mechanisms of fluid movement may be responsible for short-term volume changes, with different relative magnitudes and rates in different amputees.