Prosthetics and Orthotics International

Improving ankle-foot orthosis design can best be done by implementing a user-centered approach.

To provide insight into the ideas of ankle-foot orthosis users with flaccid ankle muscle paresis on the importance of activities and suggestions for an improved ankle-foot orthosis design.

A focus-group discussion with eight ankle-foot orthosis users (57 ± 5 years, 50% female).

Main inclusion criteria were as follows: ⩾18 years, unable to stand on tip-toe and unable to lift toes. Main exclusion criterion was spasticity of lower extremity muscles. Transcribed data were coded according to the International Classification of Functioning, Disability and Health. Thematic analysis with inductive approach was chosen to order and interpret codes.

Ankle-foot orthosis users ranked walking the most important activity followed by sitting down/standing up from a chair. Their opinion was that ankle-foot orthoses facilitate walking and standing. Ankle-foot orthosis users suggested that an improved ankle-foot orthosis design should balance between stability and flexibility.

Current ankle-foot orthoses facilitate walking which was the most important activity according to ankle-foot orthosis users. An improved ankle-foot orthosis design should enable walking and should optimize between stability and flexibility dependent on the activity and the paresis severity.

Experienced users of ankle-foot orthosis agreed that matching ankle-foot orthosis functions to daily-life activities is a trade-off between stability and flexibility. An improved ankle-foot orthosis design should at least enable level walking.

Evaluation of the effects of brace treatment on quality of life in adolescent idiopathic scoliosis is important.

To analyze the validity and reliability of the Turkish version of the Brace Questionnaire.

Cohort study, evaluation of reliability and validity of the Turkish version of the Brace Questionnaire.

Twenty-eight patients undergoing brace treatment for adolescent idiopathic scoliosis (median age: 14.6 years) were included in the study. The Brace Questionnaire was translated into Turkish and administered to the patients twice at an interval of 5 days. Reliability was assessed using the test–retest method (Pearson’s correlation coefficient); internal consistency was analyzed using Cronbach’s alpha. Validity was assessed by correlating the Brace Questionnaire with the Bad Sobernheim Stress Questionnaire-Brace and Scoliosis Research Society-22 questionnaire.

The mean Cobb angles were 31.1° ± 8.3° and 29.7° ± 9° for thoracic and lumbar regions, respectively. Cronbach’s alpha was 0.94. Intraclass correlation coefficient was 0.95 in test–retest reliability analysis. The correlations between Brace Questionnaire and Bad Sobernheim Stress Questionnaire-Brace and Scoliosis Research Society-22 were r = 0.67 and r = 0.64, respectively.

The Turkish version of the Brace Questionnaire to measure the effects of brace treatment on quality of life in adolescent idiopathic scoliosis was found to have good validity, excellent reliability, and high internal consistency.

We recommend routine use of the Brace Questionnaire in scoliosis patients to evaluate brace-related quality of life and relevant factors and to support the individual when necessary during such treatment.

Fall prevention is essential in patients after arthroscopic rotator cuff repair because of the high risk of re-rupture. However, there are no reports related to falls that occur during the early postoperative period, while the affected limb is immobilized.

This study assessed gait performance and falls in patients using a shoulder abduction brace after arthroscopic rotator cuff repair.

Prospective cohort and postoperative repeated measures.

This study included 29 patients (mean age, 67.1 ± 7.4 years) who underwent arthroscopic rotator cuff repair followed by rehabilitation. The timed up and go test, Geriatric Depression Scale, and Falls Efficacy Scale were measured, and the numbers of falls were compared between those shoulder abduction brace users and patients who had undergone total hip or knee arthroplasty.

In arthroscopic rotator cuff repair patients, there were significant improvements in timed up and go test and Geriatric Depression Scale, but no significant differences in Falls Efficacy Scale, between the second and fifth postoperative weeks (p < 0.05). Additionally, arthroscopic rotator cuff repair patients fell more often than patients with total hip arthroplasty or total knee arthroplasty during the same period.

The findings suggest that rehabilitation in arthroscopic rotator cuff repair patients is beneficial, but decreased gait performance due to the immobilizing shoulder abduction brace can lead to falls.

Although rehabilitation helps motor function and mental health after arthroscopic rotator cuff repair, shoulder abduction brace use is associated with impaired gait performance, high Falls Efficacy Scale scores, and risk of falls, so awareness of risk factors including medications and lower limb dysfunctions is especially important after arthroscopic rotator cuff repair.

Older adults with amputations secondary to vascular etiologies may additionally present with cognitive impairment. Cognition plays an important role in the adoption of a prosthetic limb, although the degree and type of impact are debated. Previous literature reviews have not been directed at the specific population of older adults who underwent vascular-related lower limb amputation.

First, to assess extant literature for relationships between cognitive function and prosthesis-related outcomes in older adults who underwent lower limb amputation for vascular-related etiologies. Second, to perform a critical analysis of prosthesis-related outcomes and cognitive assessments performed in the studies.

Systematic literature review.

A systematic review of the literature was performed in databases using keyword combinations. A total of nine articles were selected to be included in this review.

Seven of the nine included studies found a relationship between decreased cognitive function and reduced performance on a prosthesis-related outcome. There were eight different prosthesis-related outcome measures, with only one study utilizing a comprehensive outcome measure.

Cognitive impairment can negatively impact successful prosthesis use in older adults with lower limb amputation secondary to vascular complications. Future studies should utilize comprehensive outcome measures that represent the multifaceted constructs of cognition and prosthesis use.

Cognitive assessment of older adults who have undergone lower limb amputation secondary to diabetes related complications or vascular disease can be used to inform clinical decision-making. Clinicians should consider selecting prosthesis-related outcome measures that capture the full breadth of prosthesis use when evaluating patients with cognitive impairment.

Orthotic insoles that are made of foam material often have less breathability and thus cause discomfort to the wearer. Given that a sandwich structure offers better porosity and breathability that would improve comfort, the impact of custom-made insoles made with three-dimensional spacer fabric is studied.

To examine the biomechanical effects and subjective comfort of spacer-fabric insoles during walking.

Repeated measures.

Plantar pressure and lower limb muscle activity data are collected from 12 subjects. Subjective perceived comfort is measured after five successful walking trials for each of the three different insoles worn: traditional insoles made with ethylene vinyl acetate and two types of spacer-fabric insoles.

Compared to the use of traditional insoles, there is a statistically significant reduction in the peak pressure (>8%) and pressure-time integral (>16%) in the toes and metatarsal head 1 with the use of the spacer-fabric insoles as the top layer. Insoles with two layers of spacer fabrics have the highest perceived comfort (p < 0.01). However, there is no significant difference in the selected muscle activity for all three insoles.

Insoles with different arrangements of spacer fabrics allow changes in pressure patterns across the plantar foot and perception of comfort while walking. The findings enhance current understanding on the use of textile-fabricated materials, which provide alternative solutions for modifying insoles.

The key features of spacer fabric offer a viable option for different orthotic insole applications. The results will greatly contribute toward insole prescription, potentially enhancing the efficacy of orthotic performance and increasing the range of insole materials.

Silicone toe separator is considered as a conservative treatment for hallux valgus. The prefabricated toe separator does not fit all. However, effectiveness in prescription of the custom-mold toe separator is still unknown.

To investigate the effect of using a custom-mold room temperature vulcanizing silicone toe separator to decrease hallux valgus angle and hallux pain. The compliances, complications, and satisfactions of toe separator were also explored.

A prospective, randomized single-blinded controlled trial.

A total of 90 patients with a moderate degree of hallux valgus were enrolled in a study at the Foot Clinic, Siriraj Hospital, Thailand. Patients were randomized into two groups; the study group was prescribed a custom-mold room temperature vulcanizing silicone toe separator for 6 h per night for 12 months. Patients in both groups received proper foot care and shoes and were permitted to continue drug treatment.

In total, 40 patients in the study group and 39 patients in the control group completed the study. The hallux valgus angle was obtained through radiographic measurement. At month 12, both groups had significant differences in mean hallux valgus angle with a decrease of 3.3° ± 2.4° for the study group and increase of 1.9° ± 1.9° for the control group. There were statistically significant differences of hallux valgus angle between the two groups (p < 0.05) at the end of the study. Hallux pain was decreased in the study group.

A custom-mold room temperature vulcanizing silicone toe separator can decrease hallux valgus angle and pain with no serious complications.

The custom-mold room temperature vulcanizing silicone toe separator for treatment of hallux valgus reduces deformity and hallux pain.

The role of the prosthetist has changed substantially over the past century. In the transition from ‘limb-maker’ to ‘clinician’, the expectations of prosthetics professionals have also changed.

To develop and test a new scale capable of assessing and comparing current expectations of the roles of the prosthetist.

Scale development and validation.

A new scale was constructed in accordance with Organizational Role Theory. It comprised 72 items that subdivide into 11 subscales. Face, content and construct validity, along with test–retest and inter-rater reliability were evaluated.

The Prosthetist Role Expectations Scale was found to be psychometrically sound, reliable for use in a range of settings and clinically feasible in a sample of 17 Australian therapists.

The Prosthetist Role Expectations Scale demonstrated robust psychometric properties and appears well suited to monitoring current expectations of the role of the prosthetist in health service delivery.

The Prosthetist Role Expectations Scale can identify current expectations of the role of the prosthetist, showing areas of consensus and conflict between key professional and client groups. Wider use of the instrument will contribute to increased understanding of professional roles. This may help to reduce role conflict and improve communication within healthcare teams.

There is a known shortage of rehabilitation staff in rural settings and a sharp increase in the number of lower limb amputations being performed. A lack of adequate pre-prosthetic rehabilitation will result in worse physical and psychological outcomes for a person with a lower limb amputation, and they will not be eligible to be fitted with a prosthesis.

To explore therapists’ experiences with providing pre-prosthetic rehabilitation in a rural setting.

A qualitative descriptive approach was used to collect and analyse data.

Data were collected from 17 purposively sampled therapists in five district hospitals in a rural community in South Africa. Data were collected in two rounds of focus groups to explore the challenges of providing pre-prosthetic rehabilitation in rural South Africa.

The main themes identified in the study were (1) a lack of government health system support, (2) poor socioeconomic circumstances of patients and (3) cultural factors that influence rehabilitation. These themes all negatively influence the therapists’ ability to follow up patients for pre-prosthetic rehabilitation after discharge from hospital. A lack of adequate pre-prosthetic rehabilitation is a substantial barrier to prosthetic fitting in rural South Africa. Patients who do not receive pre-prosthetic rehabilitation have a poorly shaped residuum or other complications such as knee or hip joint contractures which disqualifies them from being referred to prosthetic services.

Therapists involved in this study identified the most important barriers to patients having access to prosthetic services.

Pre-prosthetic rehabilitation provides care of the residuum; maintenance or improvement of physical strength, joint range of motion and referral to a prosthetist. By exploring the challenges known to exist in this service, we can identify potential ways to reduce these barriers and improve the lives of those who use it.

Due to advancements in three-dimensional printing, custom-made prostheses are becoming more viable options for persons with difficult cases of prosthetic management. The purpose of this article was to develop a custom voluntary-closing, body-powered thumb mechanism for a partial-hand amputee who had amputations of the index finger and thumb on the left, non-dominant hand.

The prosthesis model was manufactured using rapid prototype technology and was developed to provide greater force and functionality, and to decrease overall size compared to traditional hand prostheses.

Following device iterations and occupational therapy sessions, the patient achieved higher functionality in performing daily tasks such as cooking and cleaning, and in completing the Box and Blocks test, though some limitations still precluded full acceptance of the device.

This case study represents a unique approach in the development of custom-made devices that may increase prostheses acceptance rates among partial-hand amputees.

Many partial-hand amputees report experiencing trouble in finding a device that fits their needs. This study highlights the potential of using rapid prototyping technology to design a prosthesis that meets a user’s specific desires.

While Amputee Mobility Predictor scores differ between Medicare Functional Classification Levels (K-level), this does not demonstrate that the Amputee Mobility Predictor can accurately predict K-level.

To determine how accurately K-level could be predicted using the Amputee Mobility Predictor in combination with patient characteristics for persons with transtibial and transfemoral amputation.

Prediction.

A cumulative odds ordinal logistic regression was built to determine the effect that the Amputee Mobility Predictor, in combination with patient characteristics, had on the odds of being assigned to a particular K-level in 198 people with transtibial or transfemoral amputation.

For people assigned to the K2 or K3 level by their clinician, the Amputee Mobility Predictor predicted the clinician-assigned K-level more than 80% of the time. For people assigned to the K1 or K4 level by their clinician, the prediction of clinician-assigned K-level was less accurate. The odds of being in a higher K-level improved with younger age and transfemoral amputation.

Ordinal logistic regression can be used to predict the odds of being assigned to a particular K-level using the Amputee Mobility Predictor and patient characteristics. This pilot study highlighted critical method design issues, such as potential predictor variables and sample size requirements for future prospective research.

This pilot study demonstrated that the odds of being assigned a particular K-level could be predicted using the Amputee Mobility Predictor score and patient characteristics. While the model seemed sufficiently accurate to predict clinician assignment to the K2 or K3 level, further work is needed in larger and more representative samples, particularly for people with low (K1) and high (K4) levels of mobility, to be confident in the model’s predictive value prior to use in clinical practice.

Prosthetic feet are prescribed based on their mechanical function and user functional level. Subtle changes to the stiffness and hysteresis of heel, midfoot, and forefoot regions can influence the dynamics and economy of gait in prosthesis users. However, the user’s choice of shoes may alter the prosthetic foot-shoe system mechanical characteristics, compromising carefully prescribed and rigorously engineered performance of feet.

Observe the effects of footwear on the mechanical properties of the prosthetic foot-shoe system including commonly prescribed prosthetic feet.

Repeated-measures, Mechanical characterization.

The stiffness and energy return was measured using a hydraulic-driven materials test machine across combinations of five prosthetic feet and four common shoes as well as a barefoot condition.

Heel energy return decreased by an average 4%–9% across feet in all shoes compared to barefoot, with a cushioned trainer displaying the greatest effect. Foot designs that may improve perceived stability by providing low heel stiffness and rapid foot-flat were compromised by the addition of shoes.

Shoes altered prosthesis mechanical characteristics in the sagittal and frontal planes, suggesting that shoe type should be controlled or reported in research comparing prostheses. Understanding of how different shoes could alter certain gait-related characteristics of prostheses may aid decisions on footwear made by clinicians and prosthesis users.

Shoes can alter function of the prosthetic foot-shoe system in unexpected and sometimes undesirable ways, often causing similar behavior across setups despite differences in foot design, and prescribing clinicians should carefully consider these effects on prosthesis performance.

To improve gait function in children with cerebral palsy, ankle-foot orthoses are often prescribed. However, until now, little attention has been devoted to the effect of ankle-foot orthoses on the postural control during walking in children with cerebral palsy.

The aim was to compare the differences in thorax, spine, and pelvis movements in children with cerebral palsy during walking barefoot and walking with ankle-foot orthoses.

Clinical study with an intra subject design.

A total of 15 children (12 boys and 3 girls; mean age, 8 ± 2 years) with bilateral spastic cerebral palsy (12 with Gross Motor Function Classification System I and 3 with Gross Motor Function Classification System II) performed a full-body three-dimensional gait analysis. Differences in the range of motion of the thorax, spine, and pelvis during walking barefoot and walking with bilateral ankle-foot orthoses were analyzed (SPSS v20, paired-samples t-test).

Children with cerebral palsy showed a significantly larger range of motion of the thorax (flexion/extension, lateral bending, and rotation) and the spine (lateral bending) during walking with ankle-foot orthoses compared to walking barefoot. No significant differences were found in the range of motion of the pelvis between these two conditions.

It can be concluded that wearing ankle-foot orthoses influences the postural control during walking in children with bilateral spastic cerebral palsy. Due to the increased range of motions, the movement pattern of the trunk diverges from the typically developing children.

Wearing ankle-foot orthoses not only gives more stability at the pelvis and ankle joint but also influences trunk motion. In order of the level of core stability of the child, compensations can be either seen in the lower back or the upper trunk. Clinicians should be aware of these compensations and should evaluate postural control in a more detailed evaluation.

Recent literature indicates equivalent costs of walking can be achieved after a transtibial amputation when the individual is young, active, and/or has extensive access to rehabilitative care. It is unknown if a similar cohort with transfemoral amputation can also achieve lower metabolic costs of walking than previously reported.

Compare metabolic cost in individuals with a transfemoral amputation to controls and to the literature across a range of walking speeds.

Cross-sectional.

A total of 14 individuals with a unilateral transfemoral amputation (27 ± 5 years, N = 4 mechanical knee, N = 10 microprocessor knee) and 14 able-bodied controls (26 ± 6 years) walked at self-selected and four standardized speeds. Heart rate, metabolic rate (mL O₂/kg/min), metabolic cost (mL O₂/kg/m), and rating of perceived exertion were calculated.

Self-selected speed was 8.6% slower in the transfemoral amputation group (p = 0.031). Across standardized speeds, both metabolic rate and metabolic cost ranged from 44%–47% greater in the transfemoral amputation group (p < 0.001), heart rate was 24%–33% greater (p < 0.001), and perceived exertion was 24%–35% greater (p < 0.009).

Although the transfemoral amputation group was relatively young, physically fit, and had extensive access to rehabilitative care, the metabolic cost of walking fell within the ranges of the literature on older or presumably less fit individuals with transfemoral amputation.

Developments in prosthetic technology and/or rehabilitative care may be warranted and may reduce the metabolic cost of walking in individuals with a transfemoral amputation.

A recent survey of people with lower limb absence revealed that patients’ satisfaction with their foam cosmesis is lower than desired. The aim of this project was to improve the lifelike appearance, functionality and durability of the cosmesis through a user-centred design methodology.

Concept development and prototyping led to a new cosmesis design which features a cut-out located at the knee, inserted with an artificial patella made of a more rigid foam. It also features a full-length zip which provides easy access for maintenance. The new cosmesis was then mechanically tested for over 1 million cycles and clinically tested by six transfemoral prosthesis users over 18 patient months.

The new design is significantly more durable than the current standard model and has an enhanced lifelike appearance. It has potential to improve users’ body image and reduce costs for healthcare providers.

This study contributes to practice by offering a new cosmesis design with enhanced appearance and durability, with the potential to improve patients’ body image and reduce costs associated with cosmesis fitting and maintenance.

Despite the evidence for improved safety and function of microprocessor stance and swing-controlled prosthetic knees, non-microprocessor-controlled prosthetic knees are still standard of care for persons with transfemoral amputations in most countries. Limited feature microprocessor-control enhancement of such knees could stand to significantly improve patient outcomes.

To evaluate gait speed, balance, and fall reduction benefits of the new 3E80 default stance hydraulic knee compared to standard non-microprocessor-controlled prosthetic knees.

Comparative within-subject clinical study.

A total of 13 young, high-functioning community ambulators with a transfemoral amputation underwent assessment of performance-based (e.g. 2-min walk test, timed ramp/stair tests) and self-reported (e.g. falls, Activities-Specific Balance Confidence scale, Prosthesis Evaluation Questionnaire question #1, Satisfaction with the Prosthesis) outcome measures for their non-microprocessor-controlled prosthetic knees and again after 8 weeks of accommodation to the 3E80 microprocessor–enhanced knee.

Self-reported falls significantly declined 77% (p = .04), Activities-Specific Balance Confidence scores improved 12 points (p = .005), 2-min walk test walking distance increased 20 m on level (p = .01) and uneven (p = .045) terrain, and patient satisfaction significantly improved (p < .01) when using the 3E80 knee. Slope and stair ambulation performance did not differ between knee conditions.

The 3E80 knee reduced self-reported fall incidents and improved balance confidence. Walking performance on both level and uneven terrains also improved compared to non-microprocessor-controlled prosthetic knees. Subjects’ satisfaction was significantly higher than with their previous non-microprocessor-controlled prosthetic knees. The 3E80 may be considered a prosthetic option for improving gait performance, balance confidence, and safety in highly active amputees.

This study compared performance-based and self-reported outcome measures when using non-microprocessor and a new microprocessor-enhanced, default stance rotary hydraulic knee. The results inform rehabilitation professionals about the functional benefits of a limited-feature, microprocessor-enhanced hydraulic prosthetic knee over standard non-microprocessor-controlled prosthetic knees.

The dysfunction of individuals with upper limb deficiencies affects their daily lives and social participation.

To clarify the adaptive behaviours and motor skills of children with upper limb deficiencies.

Cross-sectional survey.

The subjects were 10 children ranging from 1 to 6 years of age with unilateral upper limb deficiencies at the level distal to the elbow who were using only cosmetic or passive prostheses or none at all. To measure their adaptive behaviour and motor skills, the Vineland Adaptive Behavior Scales, Second Edition was used. They were evaluated on the domains of communication, daily living skills, socialization and motor skills. We also examined the relationship of the scores with age.

There were no statistically significant scores for domains or subdomains. The domain standard score of motor skills was significantly lower than the median scores of the domains and was negatively correlated with age.

Children with upper limb deficiencies have individual weaknesses in motor skill behaviours, and these weaknesses increase with age. It may be helpful in considering approaches to rehabilitation and the prescription of prostheses to consider the characteristics and course of children’s motor skill behaviours.

Even if children with unilateral upper limb deficiencies seem to compensate well for their affected limb function, they have or will experience individual weaknesses in motor skills. We should take this into consideration to develop better strategies for rehabilitation and prostheses prescriptions.