Impact of plantar flexion resistive moment of dynamic ankle foot orthosis on measures of center of pressure and clinical gait outcomes in individuals with post-stroke hemiparesis.

BACKGROUND: An ankle-foot orthosis (AFO) with plantar flexion resistance (PFR) can improve the first rocker function during gait, but the incremental changes in the resistive moment on balance and gait have not been well identified. OBJECTIVES: To investigate the effect of changing the PFR moment of dynamic AFO (DAFO) on measures of the center of pressure (COP) and clinical gait outcomes in individuals with post-stroke hemiparesis. METHOD: In this randomized repeated measure study of 36 stroke individuals, the customized DAFO using foot drop ankle units set in three PFR situations (low, medium, and high) was evaluated. The balance parameters for COP measures were investigated by HUMAC® Balance & Tilt System. Gait parameters and ankle kinematics were recorded using the 3D motion analysis through force platform and optoelectronic system. The comparison was made using a parametric ANOVA test and the P value was set at 0.05 for statistical significance. RESULTS: Significant differences were observed for COP average velocity (1.30 ± 0.64, 1.10 ± 0.05, and 1.37 ± 0.43), COP path length (43.3 ± 4.6, 33.4 ± 4.3, and 36.3 ± 5.4), walking velocity (11.0 ± 3.1, 13.2 ± 4.4, and 9.9 ± 3.5), and cadence (31.5 ± 2.0, 33.0 ± 3.1, and 29.0 ± 1.6) respectively for low, medium and high PFR settings (P < 0.05). Except for the COP path length and cadence, posthoc multiple comparisons revealed significant differences between low and medium (P < 0.05) and medium and high (P < 0.05) PFR grades. PFR with medium resistance demonstrated near-normal maximal peak ankle dorsiflexion (mean deviation of 8 degrees, P < 0.05). CONCLUSION: Medium PFR grade should be encouraged since it can enhance balance parameters like path length and average velocity of COP, increase cadence and average velocity during gait, and improve maximal peak ankle dorsiflexion.

Efficacy of extension wrist hand orthosis on pain, grip strength and electromyographic activities in lateral epicondylitis: A randomized single-blind clinical trial.

BACKGROUND: Lateral epicondylitis (LE) is one of the most common work-related complications characterized by pain, decreased grip strength and dysfunction of upper limb. Although conservative management such as physiotherapy and orthosis is reported as first line of treatment, sufficient evidence to decide their effectiveness is lacking and remains controversial. PURPOSE: The current study evaluated and compared the efficacy of a custom-made extension wrist hand orthosis adjunct to usual physiotherapy and therapeutics alone for subjects with LE. STUDY DESIGN: Prospective randomized single-blinded clinical trial. METHODS: 62 subjects with LE were selected as samples using convenience method in this experimental study. They were randomly divided into two groups: usual physiotherapy only and its combination with orthosis. Pain and grip strength were measured using Visual Analog Scale and Jamar hydraulic digital hand dynamometer. Muscle activity of extensor carpi radialis brevis during hand gripping was measured using surface electro-myographic by PowerLab electromyography (AD Instruments, Castle Hill, Australia). Data analysis and comparison were performed for baseline and post-intervention (12weeks). RESULTS: After 12weeks of treatment, there were significant differences in mean scores of pain (1.22 ± 0.51, p = 0.001), maximum voluntary grip strength (5.82 ± 7.84, p = 0.04), and extensor carpi radialis brevis muscle activation (0.082 ± 0.094, p = 0.02) between the therapeutics alone group and the therapeutics plus orthosis group. Compared to therapeutics alone, those getting a combination of physiotherapy and orthosis had greater treatment efficacy (p < 0.05). CONCLUSIONS: Both postintervention (12-week) treatments could affect pain scores, grip strength, and extensor muscle activation. Custom-made extension wrist hand orthosis adjunct to usual physiotherapy is more effective than therapeutics alone in subjects with LE. Therefore, the use of wrist orthosis adjunct to physiotherapy should be recommended in rehabilitation settings for LE.

Design and analysis of polycentric prosthetic knee with enhanced kinematics and stability.

This paper describes a continuation of earlier work using the finite element method to conduct an engineering failure analysis of an existing polycentric prosthetic knee. The primary purpose of this work is to enhance the quality of the existing knee which has been reported with multiple cases of failure during its clinical practice in India. A modified design of the polycentric knee has been proposed based on the findings of failure analysis. Simulation-based comparative analysis of polycentric knees has been performed as per the ISO 10328:2016 standard in terms of stress distribution, total contour deformation, safety factor, and fatigue life. The upper extension lever is subjected to static and cyclic loads of 4130 and 1230 N, whereas the lower plate has a translational constraint. The modified polycentric knee prosthesis outperforms static and fatigue strength tests. The standard of the existing knee prosthesis has significantly improved as a result of design variations and integration of high-strength and lightweight aluminium 7075-T6 alloy. The modified polycentric knee prosthesis has a predicted maximum deformation of less than 0.7 mm and a minimum safety factor between 1.7 and 2 compared to 2.66 mm and 1.0 for the existing knee prosthesis. Based on the fatigue simulation results, it is predicted that the modified polycentric knee will have a lifespan of at least ten years indicating a safe design. It has improved alignment stability and kinematics, with a significant weight reduction of 33 g, and a high cost-benefit ratio to reach the maximum amputee population in low-income countries like India.

Conformity assessment with structural strength requirements of mechanical polycentric prosthetic knee used for amputee rehabilitation.

Prosthetic restoration is an important component of amputee rehabilitation which may be subjected to a static load of nearly five times of amputees' body weight and is continuously administered to cyclic or fatigue loads during its function. This study presents a structural strength analysis of polycentric mechanical prosthetic knee commonly used in National Institutes in India by finite element simulation and its experimental validation. Static and fatigue analyses have been performed to ensure its structural integrity as per the ISO 10328:2006 standard. Accurate dimensioning of knee components have been obtained using coordinate measuring machine and the 3 D CAD model has been generated by CATIA V5 from the 2 D geometry. The model is imported to the ANSYS 20.1 workbench to study stress distribution in the knee for ensuring its safety performance. The selection of reference planes, application of calculated loads, and position of load line have been done as per the ISO test procedure. Static and cyclic loadings of 4130 N and 1230 N are applied at the top and the bottom plate is given with translational constraints to limit its movement in any direction. Results indicate that the prosthetic knee model is moderately strong enough to outstrip the static strength test. However, the calculated strain and predicted fatigue life during the cyclic test suggest that this knee unit has poor fatigue strength. Validation results with an average error percentage of 3.44 and 10 show higher reliability based on previous study results and experimental tests, respectively.

Efficacy of prosthetic rehabilitation in rotationplasty following Ewing's sarcoma: A case study.

PURPOSE: Restoration of functional mobility including gait and balance are fundamental to prosthetic rehabilitation in children with rotationplasty. The literature to characterize and investigate the correlation between postural balance and gait following rotationplasty are scarce. This study examines the characteristics of balance and prosthetic gait in a subject with rotationplasty and checks whether any association exists between them. METHODS: A 14-year-old boy with rotationplasty following Ewing's sarcoma was fitted with a custom made prosthesis. Center of pressure (COP) measures using the HUMAC® Balance & Tilt System (CSMi, Stoughton, MA), temporal-spatial gait parameters, and energy expenditure measured by a 10 meter walk test were recorded using the new and old prosthesis. A control subject was used for comparison. RESULTS: The stability score, path length, and average velocity of COP improved in a new prosthesis for both standing conditions. Gait parameters were improved and energy expenditure was marginally reduced with the new prosthesis. However, overall prosthetic gait was significantly different compared to the control subject. CONCLUSION: This subject-centric approach successfully improved balance, gait parameters, and energy expenditure by providing better alignment, fit, and comfort with a custom prosthesis.

A systematic review on design technology and application of polycentric prosthetic knee in amputee rehabilitation.

The objective of this paper is to conduct a systematic review on design technology and clinical application of polycentric prosthetic knee joint in the rehabilitation of trans-femoral amputees. Relevant studies were identified using electronic database such as PubMed, EMBASE, SCOPUS and the Cochrane Controlled Trials Register (Rehabilitation and Related Therapies) up to February 2020. Screening of abstracts and application of inclusion and exclusion criteria were made. Design, modeling, material use, kinematic study, simulation technique and clinical application of polycentric knee models used in many developed and developing countries have been reviewed. Out of 516 potentially relevant studies, 43 articles were included. Specific variables on technical and clinical aspects were extracted and added to summary tables. The results reveal that polycentric knees have a variety of geometries but the methods for comparing their performances are rare. The data of structural analysis using different simulation techniques are validated with experimental results for determining model accuracy. Gait analysis using the polycentric knee components provides a valid tool to correlate with experimental results. There are well-designed studies on the technological development of polycentric knees, however, high-quality clinical researches are scarce. Conventional clinical knowledge had considerable gaps concerning the effects of polycentric knee and their mechanical characteristics on human functioning with a lower-limb prosthesis. Still, further research is needed to develop and implement standardized measures on prosthetic knee joints for their effective use, function, durability, and cost-effectiveness.

Efficacy of two artemisinin-based combinations for the treatment of malaria in pregnancy in India: a randomized controlled trial.

BACKGROUND: In India, the recommended first-line treatment for malaria in the second and third trimester of pregnancy is artesunate + sulfadoxine-pyrimethamine (AS+SP). However, data on safety and efficacy of artemisinin-based combination therapy (ACT) in pregnancy is limited. This study assessed the safety and efficacy of AS+SP and artesunate + mefloquine (AS+MQ) for treatment of Plasmodium falciparum in pregnancy in India. METHODS: This open-label, randomized clinical trial was conducted from October 2010 to December 2013 at three sites in India (Ranchi and Jamshedpur in Jharkhand state, and Rourkela in Odisha state). Pregnant women in the second or third trimester who had P. falciparum mono-infection of any parasite density with or without fever were randomized to receive AS+SP or AS+MQ. Blood slides and filter paper samples for Polymerase Chain Reaction (PCR) were collected on days 0, 1, 2, 3, 14, 21, 28, 42 and 63 post treatment. Women were followed up at delivery and at day 42 postpartum. FINDINGS: Two hundred and forty-eight women of 7064 pregnant women (3.5%) who were screened at monthly antenatal clinics had a P. falciparum mono-infection and were randomized to receive AS+SP (125) or AS+MQ (123) and all of these women were included in the intention to treat (ITT) analysis. The primary endpoint of an adequate clinical and parasite response (ACPR) on day 63 was not available for 9 women who were counted as treatment failure in the ITT analysis. In the ITT population, the ACPR was 121/125 (96.8%; 95% Confidence interval (CI) 92.0-99.1%) in the AS+SP group and 117/123 (95.1%; 95% CI 89.7-98.2) in the AS+MQ group. Among the 239 women (121 from the AS+SP arm and 118 from the AS+MQ arm) who completed the day 63 follow up (per protocol analysis) the ACPR was 100% in the AS+SP group and 99.2% (117/118) in the AS+MQ group. There were five serious adverse events (SAE) among pregnant women (4 in the AS+SP group and 1 in the AS+MQ group) and 13 fetal/neonatal SAEs (7 in the AS+SP group and 6 in the AS+MQ) but none of them were related to the study drugs. A higher proportion of women in the AS+MQ arm reported vomiting within 7 days post-treatment than did women in the AS+SP arm (6.9 vs. 1.6%; p = 0.001). CONCLUSION: Both AS+SP and AS+MQ are safe and effective for treatment of uncomplicated falciparum malaria in pregnancy in India. Trial registration CTRI This study is registered with Clinical Trial Registry India (CTRI), number CTRI/2009/091/001055. Date of Registration 11 January 2010, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1185&EncHid=&userName=anvikar.

A Phase 3, Double-Blind, Randomized Study of Arterolane Maleate-Piperaquine Phosphate vs Artemether-Lumefantrine for Falciparum Malaria in Adolescent and Adult Patients in Asia and Africa.

BACKGROUND: Artemisinins, which are derived from plants, are subject to risk of supply interruption due to climatic changes. Consequently, an effort to identify a new synthetic antimalarial was initiated. A fixed-dose combination of arterolane maleate (AM), a new synthetic trioxolane, with piperaquine phosphate (PQP), a long half-life bisquinoline, was evaluated in patients with uncomplicatedPlasmodium falciparummalaria. METHODS: In this multicenter, randomized, double-blind, comparative, parallel-group trial, 1072 patients aged 12-65 years withP. falciparummonoinfection received either AM-PQP (714 patients) once daily or artemether-lumefantrine (A-L; 358 patients) twice daily for 3 days. All patients were followed up until day 42. RESULTS: Of the 714 patients in the AM-PQP group, 638 (89.4%) completed the study; of the 358 patients in the A-L group, 301(84.1%) completed the study. In both groups, the polymerase chain reaction corrected adequate clinical and parasitological response (PCR-corrected ACPR) on day 28 in intent-to-treat (ITT) and per-protocol (PP) populations was 92.86% and 92.46% and 99.25% and 99.07%, respectively. The corresponding figures on day 42 in the ITT and PP populations were 90.48% and 91.34%, respectively. After adjusting for survival ITT, the PCR-corrected ACPR on day 42 was >98% in both groups. The overall incidence of adverse events was comparable. CONCLUSIONS: AM-PQP showed comparable efficacy and safety to A-L in the treatment of uncomplicatedP. falciparummalaria in adolescent and adult patients. AM-PQP demonstrated high clinical and parasitological response rates as well as rapid parasite clearance. CLINICAL TRIALS REGISTRATION: India. CTRI/2009/091/000101.

Primary Pulmonary Primitive Neuro-Ectodermal Tumour (PNET) in an Eight-Year-Old Girl - A Rare Case.

Primitive Neuro-Ectodermal-Tumours (PNET) and Ewing's sarcoma are part of the spectrum of Ewing's Family of Tumours (EFT) and show varying degrees of neuroectodermal differentiation. Both these tumours share similar histological and genetic features. PNETs arising primarily in the lungs without pleural or chest wall involvement are extremely rare. We report a case of pulmonary PNET in an eight-year-old girl. To the best of our knowledge, this is the youngest case of primary pulmonary PNET to be reported in paediatric age group in the Indian literature.

Cytodiagnosis of sternocleidomastoid tumor of infancy.

Sterocleidomastoid tumor of infancy (SCMI), also known as fibromatosis colli of infancy, is a benign, self limiting disease of new born characterised by its classical history and clinical presentation of firm to hard fusiform mass in the lower and middle portion of sternocleidomastoid. SCMI often appears during early perinatal period between second to fourth weeks of life. A well recognized association between SCMI and primiparous birth, breech presentation, prolonged difficult labor and forceps deliveries is found. Cytology shows spindle shaped mature fibroblastic cells scattered singly along with degenerated and multinucleated giant muscle cells in a clean background. It is important to differentiate this lesion from different forms of infantile fibromatosis. Fine-needle aspiration cytology (FNAC), as a time saving, rapid and reliable diagnostic procedure, has got bigger role to play in reassurance of anxious parents, guiding for conservative management and avoiding surgery.

Arterolane maleate plus piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: a comparative, multicenter, randomized clinical trial.

BACKGROUND: Artemisinin-based combination therapy is the first-line treatment for uncomplicated falciparum malaria. This study assessed the antimalarial efficacy and safety of a combination of 150 mg of arterolane maleate and 750 mg of piperaquine phosphate (AM-PQP) in comparison to Coartem (artemether and lumefantrine) in patients with acute uncomplicated P. falciparum malaria. METHODS: In this open-label, randomized, multicentric, parallel group clinical trial, 240 patients were randomized to receive AM-PQP (160 patients) or Coartem (80 patients). Patients with P. falciparum monoinfection and initial parasite densities ranging from 1000 to 100 000 asexual parasites/µL of blood were followed for 28 days. Polymerase chain reaction-corrected adequate clinical and parasitologic response on day 28, parasite clearance time, and fever clearance time were evaluated. RESULTS: A total of 151 (94.4%) of 160 patients in the AM-PQP group completed the trial, while 77 (96.3%) of 80 patients in the Coartem group completed the trial. No treatment failure was noted in the AM-PQP group, while one patient receiving Coartem failed treatment on day 28. There was no difference in the median parasite clearance time (30 hours in both groups) or median fever clearance time (24 hours in both groups) after administration of the 2 study treatments. CONCLUSIONS: The available data support the evaluation of a drug combination in a larger population as a fixed-dose combination. Clinical Trials Registration. CTRI/2007/091/000031.

The effect of a spinal orthosis on posture and cardio-respiratory functions in progressive myopathic scoliosis.

BACKGROUND: Historically, the orthotic treatment in progressive myopathic scoliosis has not been as effective as expected. The purpose of this study was to investigate the effect of a spinal orthosis on scoliotic curve correction, alignment of altered posture and cardio-respiratory functions. CASE DESCRIPTION AND METHODS: An 11 year-old girl diagnosed with myopathy was fitted with a custom molded thoraco-lumbo-sacral orthosis to enhance the sitting ability. The cardio-respiratory tests were performed by a COSMED K4 b(2); metabolic analyzer. The anterior posterior radiographs were analyzed for measuring Cobb angle and Ferguson angle. A plumb line test was used to assess the postural improvements. FINDINGS AND OUTCOMES: No significant difference was observed for variables such as O(2) consumption level, PaO(2), tidal volume, heart rate and energy expenditure/min. The improved posture was evident by shifting of the plumb line 18 mm towards the mid line with the use of orthosis. Very minor improvements in both angles were observed with the use of the brace. CONCLUSION: The brace treatment cannot be expected to have a lasting corrective effect although it can be used as a sitting support and for maintaining posture Clinical relevance This case study provides an objective prescription of thoraco-lumbo-sacral orthosis as a sitting support and for improving posture in progressive myopathic scoliosis if suitably designed and properly fitted.

Sinonasal inverted schneiderian papilloma.

Inverted papilloma of paranasal sinuses are rare disorders of fifth & sixth decade of life, have been characterised by their usually benign histologic features, their ability to grow rapidly with bone destruction, und their tendency to recur if not adequately treated. We hereby report such an uncommon case of Schneiderian papilloma in a young patient and its management with a brief review of literature.