Correlation between the Gait Deviation Index and gross motor function (GMFCS level) in children with cerebral palsy

Aim

The Gait Deviation Index (GDI) is a score derived from three-dimensional gait analysis (3DGA). The GDI provides a numerical value that expresses overall gait pathology (ranging from 0 to 100, where 100 indicates the absence of gait pathology). The aim of this study was to investigate the association between the GDI and different levels of gross motor function [defined as the Gross Motor Function Classification System (GMFCS)] and to explore if age, height, weight, gender and cerebral palsy (CP) subclass (bilateral and unilateral CP) exert any influence on the GDI in children with unilateral and bilateral spastic CP.

Methods

We calculated the GDI of 109 children [73 % boys, mean age 9.7 years (standard deviation, SD 3.5)] with spastic CP, classified at GMFCS levels I, II and III. Twenty-three normally developing children were used as controls [61 % boys, mean age 9.9 years (SD 2.6)]. Multiple linear regression analysis was performed.

Results

The mean GDI in the control group was 100 (SD 7.5). The mean GDI in the GMFCS level I group was 81 (SD 11), in the GMFCS level II group 71 (SD 11) and in the GMFCS level III group 60 (SD 9). Multiple linear regression analysis showed that gender, age and CP subclass had no significant correlation with the GDI, whereas height and weight had a slight impact.

Conclusion

This study showed a strong correlation between the GDI and GMFCS levels. The present data indicate that calculation of the GDI is a useful tool to characterise walking difficulties in children with spastic CP.

     

Management of spinal deformity in cerebral palsy: conservative treatment

Introduction

The incidence of scoliosis in Cerebral Palsy (CP) is directly related to the Gross Motor Function Classification System (GMFCS) level. The natural history of untreated scoliosis in patients with CP is one of progression and factors implicated in deterioration include type of involvement (quadriplegia), poor functional status (nonambulatory, GMFCS levels IV and V), and curve location (thoracolumbar). The generally accepted incidence in the overall CP population is 20–25 %.

Materials and methods

We recently published our short term results for 31 children treated with a short lumbar brace. In cases of a "positive hands up test" we recommend a short lumbar brace, and in patients with scoliosis with a Cobb angle >20° a double shelled brace.

Results

In our study, there was a correction of 37 % for the lumbar Cobb angle and 39 % for the thoracic Cobb angle at a mean follow-up of 28 months.

Conclusion

The incidence of scoliosis in the overall CP population is 20–25 % and is directly related to the GMFCS level. Therefore, we recommend early treatment and prescribe a short lumbar brace in patients with dynamic instability of the trunk, and in scoliosis with a Cobb angle >20° a double shelled brace.     

Hip displacement in relation to age and gross motor function in children with cerebral palsy

Purpose

Hip dislocation in cerebral palsy (CP) is a serious complication. By radiographic screening and prophylactic surgery of children at risk most dislocations can be prevented. CPUP, the Swedish CP registry and follow-up program, includes annual radiographic examinations of children at Gross Motor Function Classification System (GMFCS) levels III–V. Data from CPUP were analysed to assess the risk of hip displacement in relation to GMFCS levels and age.

Methods

All children at GMFCS levels III–V (N = 353) whose first radiographic screening occurred before 3 years of age were followed between the ages 2–7 years. Migration percentages (MPs) were recorded annually (1,664 pelvic radiographs) and analysed using discrete time survival analysis.

Results

The risk of hip displacement between 2 years and 7 years of age was significantly (p < 0.05) higher for children at GMFCS level V during the entire study period. The risk was highest at 2–3 years of age and decreased significantly (p < 0.001) with each year of age (OR = 0.71, 95 % CI 0.60–0.83). The cumulative risk at age 7 years for those at GMFCS V for MP ≥ 40 % was 47 % (95 % CI 37–58). The corresponding risk at GMFCS IV was 24 % (16–34) and at GMFCS III 23 % (12–42).

Conclusions

Children at GMFCS V have a significantly higher risk of hip displacement compared with children at GMFCS III–IV. The risk is highest at 2–3 years of age. The results support a surveillance program including radiographic hip examinations as soon as the diagnosis of severe CP is suspected.     

Prevalence and pattern of upper limb involvement in cerebral palsy

Purpose

The aim of this study was to determine the prevalence and pattern of upper limb involvement in children with cerebral palsy (CP), how this relates to function and how well these problems are recognised and treated.

Methods

One hundred consecutive patients with CP attending non-hand-related clinics were assessed. Function was assessed according to the Gross Motor Functional Classification System (GMFCS), the Manual Ability Classification System (MACS) and the ABILHAND-Kids system, and correlated to age and pattern of upper limb involvement. Patients were examined for contractures in the shoulder, elbow, wrist and hand. Concerns about the appearance of the hand were also assessed in older children.

Results

Overall, 83 % of patients had upper limb involvement, 36 % had a demonstrable contracture and 69 % had reduced hand control. The most common contracture patterns were the thumb in palm with clasp hand, shoulder adduction with internal rotation and wrist flexion with pronation. The thumb in palm with clasp hand pattern was associated with the greatest functional disability, followed by wrist flexion with pronation. Single contractures such as elbow flexion caused significant disability, whereas swan-neck contractures were, by far, less debilitating. Children aged 12 years and older had more concerns about the appearance of their hand. The ABILHAND score was strongly correlated to both the GMFCS and the MACS score.

Conclusion

Different patterns of upper limb involvement exist in CP and some have a significant impact on function and cause cosmetic concerns that should not be underestimated, particularly in older children.     

Excess Body Weight Loss is Associated with Nonpathological Gait Patterns in Women 4 to 5 Years After Bariatric Surgery

Background

This study examined relationships between excess body weight (EBW) loss and current gait and functional status in women 5 years after Roux-en-Y gastric bypass surgery.

Methods

Gait data were analyzed in nine female bariatric patients for relationships with longitudinal changes in weight, body composition, and physical function assessed by the Short Musculoskeletal Functional Assessment (SMFA) questionnaire and the timed “get-up-and-go” (TGUG) test. Gait characteristics in the bariatric sample were also compared to an age- and BMI-matched nonsurgical reference sample from the Fels Longitudinal Study.

Results

Bariatric patients lost an average of 36.4 kg (61.1 %) of EBW between preoperative and 5-year follow-up visits (P?<?0.01); SMFA function index scores and TGUG times also decreased (both P?<?0.01). Degree of EBW loss was correlated with less time spent in initial double support and more time in single support (both P?=?0.02), and for all gait variables, the bariatric sample fell within the 95 % confidence intervals of gait/EBW relationships in the reference sample.

Conclusions

Gait and function 5 years after bariatric surgery were characteristic of current weight, not preoperative obesity, suggesting that substantial, sustained recovery of physical function is possible with rapid surgical weight loss.     

Femoral derotation osteotomy with multi-level soft tissue procedures in children with cerebral palsy: Does it improve gait quality?

Purpose

Poor motor control and delayed thumb function and a delay in walking are the main factors which retard the natural decrease of the femoral anteversion (FA) with age. In addition, cerebral palsy (CP) patients usually have muscular imbalance around the hip as well as muscle contractures, both of which are main factors accounting for the increased FA which is commonly present in CP patients. The purpose of this retrospective study was to analyze the mid-term results of femoral derotational osteotomy (FDO) on the clinical findings, temporospatial and kinematic parameters of gait in children with CP.

Methods

We performed a retrospective review of all patients diagnosed with CP and increased FA who were treated with FDO with multi-level soft tissue surgeries at a single institution between 1992 and 2011. FA assessment was done in the prone position, and internal (IR) and external rotation (ER) of the hip was measured in the absence of pelvis rotation. Surgical procedures were performed on the basis of both clinical findings and video analysis. Clinical findings, Edinburgh Visual Gait Scores (EVGS) and results from three-dimensional gait analysis were analyzed preoperatively and last follow-up.

Results

A total of 93 patients with 175 affected extremities were included in this review. Mean age was 6.2 ± 3.1 (standard deviation) at initial surgery. The average length of the follow-up period was 6.3 ± 3.7 years. At the last follow-up, the postoperative hip IR had significantly decreased (73.9° vs. 46.2°; p < 0.0001), the hip ER had significantly improved (23.8° vs. 37°; p < 0.0001) and the popliteal angle had significantly decreased (64.2° vs. 55.8°; p < 0.0001). The total EVGS showed significant improvement after FDO (35.2 ± 6.4 vs. 22.5 ± 6.1; p < 0.001). Computed gait analysis showed significant improvement in the foot progression angle (FPA; 8.1° vs. ?16.9°; p = 0.005) and hip rotation (?13.9° vs. 5.7°; p = 0.01) at the last follow-up. Stance time was improved (60.2 vs. 65.1 %; p = 0.02) and swing time was decreased (39.9 vs. 35.2 %; p = 0.03). Double support time and cadence were both decreased (p = 0.032 and p = 0.01).

Conclusions

Our data suggest that the FDO is an appropriate treatment strategy for the correction of FA and associated in-toeing gait in children with CP. Improvements in clinical and kinematic parameters were observed in both groups after FDO with multi-level soft tissue release. The most prominent effects of FDO were on transverse plane hip rotation and FPA.

     

The Root-Ely Modified Test of Rectus Femoris Spasticity Has Reliability in Individuals with Cerebral Palsy

Background

Stiff-knee gait is a common gait deviation in individuals with cerebral palsy (CP) due to rectus femoris (RF) muscle spasticity. The Duncan-Ely test is a velocity-dependent measurement of spasticity that is recorded as positive or negative. At our institution, we use a modification of the Duncan-Ely test, a 5-point ordinal rating scale, which delineates where the catch occurs within the rapid arc of knee flexion. It has been named the Root-Ely test.

Questions/Purposes

We sought to determine the intra- and inter-rater reliability of the Duncan-Ely and Root-Ely tests in pediatric patients with CP.

Methods

A convenience sample of 20 ambulatory subjects was recruited; mean age was 10.5?±?4.5 years, and the Gross Motor Function Classification System (GMFCS) levels were I–III. Five clinicians measured each individual’s RF spasticity using the Root-Ely protocol during a single visit. Simple κ statistics with 95% confidence intervals (CI) were utilized for intra-rater reliability and weighted κ statistics with 95% CI for inter-rater reliability.

Results

The Root-Ely scale intra-rater reliability was 0.77 to 0.90 and inter-rater reliability was 0.32 to 0.87. Inter-rater reliability was good to excellent among experienced clinicians and fair to moderate in new clinicians.

Conclusion

The Root-Ely 5-point scale has acceptable intra- and inter-rater reliability in pediatric individuals with CP among experienced clinicians. The Root-Ely test allows experienced clinicians to reliably quantify severity of RF spasticity and may give orthopaedic surgeons a clinical tool to better predict ideal candidates for RF transfers in individuals with CP in order to improve stiff-knee gait.

     

Comparing the outcomes between Chopart,Lisfranc and multiple metatarsal shaft fractures

Objectives

Complex midfoot injuries could lead to severe functional impairment of mobility and quality of daily living. Aim of this study was to compare the clinical and functional outcomes of Chopart, Lisfranc fractures and multiple metatarsal shaft fractures.

Design

Retrospective case series.

Setting

Level one trauma center.

Intervention

Open or closed reduction and internal fixation with screws, K-wires, plates, external fixation or combination of different technics.

Main outcome measurements

The American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Score and the Maryland Foot Score were used to assess pain and functional outcome. 3D gait analysis, pedobarographic analysis and radiologic examinations were performed. The activity level was measured by a step counting accelerometer. All results were compared to an age-matched healthy control group.

Results

24 patients with a median age of 44 years (16–72) were included: 12 patients with multiple metatarsal shaft fractures, 6 patients with Chopart and 6 patients with Lisfranc fractures. The median follow-up was 2.6 years. The pedobarographic analysis reports reduced contact time of the total foot (p = 0.08), the forefoot (p = 0.008) and the hallux (p = 0.015) for the injured foot. A median score of 64 for the SF-36, 64 for the AOFAS Midfoot Score and 73 for the Maryland Foot Score indicated a poor restoration of foot function. Multiple metatarsal shaft fractures presented a significantly lower walking speed (p = 0.03) and cadence (p = 0.04).

Conclusion

The worst results were reported for multiple metatarsal shaft fractures on outcome scores, pedobarography, gait analysis and activity. Metatarsal serial fractures should not be underestimated as well as Chopart and Lisfranc fractures.

Level of evidence

Level IV.     

Chronic Pancreatitis with Benign Biliary Obstruction: Management Issues

Background

Benign biliary obstruction (BBO) is an important complication in patients with advanced chronic pancreatitis (CP). Its presentation varies from an incidental finding to overt jaundice. Thus it presents certain management issues. The present study was therefore performed to analyze the clinical presentation and management of biliary obstruction in patients with CP.

Methods

Retrospective analysis was performed from a prospectively collected database of 155 CP patients managed at our institute from October 2003 to June 2012.

Results

Among 43 (28 %) CP patients with biliary obstruction, 3 patients had evidence of malignancy on follow-up examination and were excluded from the final analysis. The various presentations include chronic nonprogressive elevation of serum alkaline phosphatase (SAP) (n = 15), a progressive increase in SAP with episodes of jaundice (n = 17), and persistent jaundice (n = 8). Of 15 patients with chronic nonprogressive elevation of SAP, 5 were managed conservatively, and the remaining 10 underwent only a pancreatic drainage procedure. During a median follow-up of 41 months (range 11–90 months), none of the 15 patients developed complications related to biliary obstruction. All patients with progressive increase in SAP levels and persistent jaundice underwent the biliary drainage procedure [choledochojejunostomy (CDJ, n = 20) and choledochoduodenostomy (CDD, n = 3)]. During a median follow-up of 30 months (range 10–89 months), two patients died of unrelated causes and two patients had an asymptomatic elevation of SAP.

Conclusions

BBO is common in patients with CP; however, biliary drainage is not indicated for chronic nonprogressive elevation of SAP. In patients with a progressive increase in SAP or persistent jaundice, both CDJ and CDD provide effective biliary drainage.     

External Tube Pancreatostomy Reduces the Risk of Mortality Associated with Completion Pancreatectomy for Symptomatic Fistulas Complicating Pancreaticoduodenectomy

Objective

This study aimed to compare the outcome of a pancreas-preserving technique consisting in a two-step procedure (external tube pancreatostomy (ETP) after resection of dehisced anastomosis followed by late anastomosis completion) with that of completion pancreatectomy (CP) for grade C fistulas complicating pancreaticoduodenectomies (PDs).

Background data

CP is the most commonly performed operation to treat a dehisced pancreato-jejunal anastomosis associated with deteriorating clinical status or hemorrhage. However, mortality of CP is high and long-term consequences are severe.

Methods

All consecutive patients who underwent PD between 1990 and 2010 were identified. Clinicopathological data, operative details, and outcomes were analyzed.

Results

Out of 370 patients, 112 (30.2 %) developed a pancreatic fistula, which was severe (grade C) in 47 cases. Forty-two patients were treated surgically by CP (n?=?23; median time following PD, 10 days), ETP (n?=?9; median time following PD, 8 days) or other various procedures (n?=?10). Indications for re-operation and operative time of CP and ETP (207.5′ versus 170′, respectively) were similar, while postoperative mortality was significantly higher after CP (43.5 % versus 0 %, p?=?0.030). Moreover, the need for a second emergency re-operation was threefold higher after CP than after ETP (39.1 % versus 11.1 %). After a median of 88 days, seven patients completed the pancreato-jejunal anastomosis without major complications or mortality. After a median follow-up of 14 months, none of the ETP patients developed diabetes.

Conclusions

External tube pancreatostomy significantly reduces the mortality associated with emergency CP. Thus, it should always be considered when deciding the treatment option in emergency surgery for severe pancreatic fistulas.     

Botulinum toxin A treatment of the lower extremities in children with cerebral palsy

Objectives

In the last 2 decades, BTX-A is increasingly being used in the management of spasticity in children with Cerebral Palsy (CP) and there is no doubt about its effect on range of motion, spasticity reduction and gait pattern in this patient population. However, in daily practice, there is still an ongoing search for the best way to apply BTX-A. Two studies were set up to evaluate how successful an integrated multilevel treatment approach is in children with CP. The first study identifies crucial factors within the treatment strategy which may predict the outcome. The second study evaluates the efficacy of repeated BTX-A injections.

Methods

Patient selection was based on following criteria: diagnosis of CP, lower limb BTX-A treatment, age at time of treatment <24 years, no combined surgery at the time of BTX-A injections, 3D gait analysis and clinical evaluation pre and 2 months post BTX-A injections. The first study included the last treatment of 577 patients. In the second study, the first and last BTX-A treatment of 222 children were included. The Goal Attainment Scale (GAS) was used to evaluate the functional outcome of each treatment session.

Results

In the first study, the mean GAS score of the total group was 51.7 (±7.5). Considering a converted total score of 50 as cut-off score for successful treatment, 67.1 % of the treatments were successful. Significantly higher GAS scores were found in mildly involved children compared to more involved children (p < 0.0001) and for multilevel injections or injections in the distal muscle groups only compared to injections in the proximal muscles of the lower limb only (p < 0.0001). Other crucial factors for a successful outcome were amount of physical therapy per week (p=0.0026), post injection casting (p=0.005) and frequency of using day and night orthoses after injection (p < 0.0001). In the second study, the mean GAS score of the total group decreased from 54.8 (±6.8) at the first treatment to 50.7 (±6.9) at the last treatment, indicating that on average, repeated BTX-A treatment is successful.

Conclusion

The integrated multilevel BTX-A approach is successful in children with CP. Several factors might help the clinician to select patients that are most likely to benefit from the treatment, to assure the most optimal treatment strategy and to predict the outcome. Each treatment should be carefully planned and goals should be well chosen, because the effectiveness of the BTX-A treatment may decrease with increasing number of treatments in the same patient.     

A multidisciplinary rehabilitation programme improves disability,kinesiophobia and walking ability in subjects with chronic low back pain: results of a randomised controlled pilot study

Purpose

To evaluate the effect of a multidisciplinary rehabilitation programme on disability, kinesiophobia, catastrophizing, pain, quality of life and gait disturbances in patients with chronic low back pain (CLBP).

Methods

This was a parallel-group, randomised, superiority-controlled pilot study in which 20 patients were randomly assigned to a programme consisting of motor training (spinal stabilising exercises plus usual-care) and cognitive–behavioural therapy (experimental group, 10 subjects) or usual-care alone (control group, 10 subjects). Before treatment, 8 weeks later (post-treatment), and 3 months after the end of treatment, the Oswestry Disability Index, the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale, and the Short-Form Health Survey were assessed. Spatio-temporal gait parameters were also measured by means of an electronic walking mat. A linear mixed model for repeated measures was used for each outcome measure.

Results

The programme had significant group (p = 0.027), time (p < 0.001), and time-by-group interaction (p < 0.001) effects on disability, with the experimental group showing an improvement after training of about 61 % (25 % in the control group). The analyses of kinesiophobia, catastrophizing, and the quality of life also revealed significant time, group, and time-by-group interaction effects in favour of the experimental group, and there was a significant effect of time on pain. Both groups showed a general improvement in gait parameters, with the experimental group increasing cadence significantly more.

Conclusion

The multidisciplinary rehabilitation programme including cognitive–behavioural therapy was superior to the exercise programme in reducing disability, kinesiophobia, catastrophizing, and enhancing the quality of life and gait cadence of patients with CLBP.     

Suture anchor tenodesis in repair of distal Achilles tendon injuries

Background

Distal Achilles tendon avulsions are in the form of either bony and nonbony avulsion of Achilles tendon from its calcaneal insertion.

Methods

Four patients with distal Achilles tendon avulsions or ruptures which were treated with tendon to bone repair using suture anchors are presented here. Operated leg was immobilized in above-knee cast for 4 weeks while the patient walked non-weight-bearing. Then, cast was changed to below knee, and full weight-bearing was allowed. Patients underwent gait analysis minimum at first postoperative year.

Results

Mean American Orthopedics Foot Ankle Society ankle/hindfoot score of patients at last visit was 88.75 (range 85–100), and Achilles tendon total rupture score was 77.75 (range 58–87). Mean passive dorsiflexion of injured ankles (14° ± 5°) was lower than uninjured ankles (23° ± 9°). All the kinematic parameters of gait analysis were comparable to the uninjured side. Maximum plantar flexion power of injured ankle was 1.40 W/kg, and this was significantly lower than the contralateral side value 2.38 W/kg; (P = 0.0143).

Conclusions

There were no visually altered gait or problems in daily life. Suture anchor tenodesis technique of distal Achilles tendon avulsions was successful in achieving durable osteotendinous repairs.     

Individualized evaluation of lumbar bone mineral density in children with cerebral palsy

Summary

Lumbar spine bone mineral density (LS-BMD) assessed by dual-energy X-ray absorptiometry (DXA) is used in children with cerebral palsy (CP) to evaluate bone health. LS-BMD results in children with CP are influenced significantly by their height, BMI, and mobility level. An adjustment for these parameters might improve the clinical significance of the method.

Purpose/introduction

DXA evaluation is considered useful in children with CP to assess bone health. For this purpose, LS-BMD is often used. The aim of the study was to estimate the effect of height, BMI, and reduced mobility level of children with CP on LS-BMD and to develop a method to adjust individual results of LS-BMD for these factors.

Methods

We conducted a monocentric retrospective analysis of data collected in children and adolescents with CP, who participated in a rehabilitation program and had no history of recurrent fractures. The DXA scan was part of the routine examination for participants older than 4 years of age. The relationship between height and BMI for age Z-scores and age-adjusted LS-BMD Z-scores was analyzed.

Results

LS-DXA scans of 500 children and adolescents with CP (Gross Motor Function Classification System levels I–V) were included in the statistical analysis (217 female). The mean age was 9.4 years (±?3.7 years). Children with moderate to severe CP had significantly (p?<?0.001) lower LS-BMD Z-scores than children with mild CP. We provided nomograms to adjust individual LS-BMD results to their height, BMI, and mobility level.

Conclusions

LS-BMD results in children with CP were influenced significantly by their height, BMI, and mobility level. An adjustment of the LS-BMD results to height, BMI, and mobility level might improve the clinical significance of an individual result.

     

Predictors of low bone mineral density of the stroke-affected hip among ambulatory individuals with chronic stroke

Summary

Risk of hip fracture is greater poststroke than in an age-matched healthy population, in part because of declining hip BMD. We found that individuals may be at risk of loss of hip BMD from muscle atrophy, asymmetrical gait, and poor affected-side ankle dorsiflexor strength. These impairments may be targeted during rehabilitation.

Introduction

This study aimed to determine predictors of low hip BMD on the stroke-affected side in people living in the community.

Methods

Forty-three participants (female; 27.9 %), mean age 62.4?±?13.5 and 17.9?±?32.8 months, poststroke with motor impairments underwent dual energy X-ray absorptiometry scans. Gait characteristics, isometric strength, body composition, and fasting plasma lipids were measured.

Results

At entry, 34.9 % (15/43) of the participants had low total hip BMD on the stroke-affected side. Of those with low BMD, 93.3 % (14/15) had a step length symmetry ratio >1, indicating greater reliance on the non-paretic leg for weight bearing. Logistic regression analysis revealed that lower affected-side ankle dorsiflexor strength (ß?=?0.700, p?=?0.02), lower total body fat-free mass index (ß?=?0.437, p?=?0.02), and greater step length symmetry ratio during walking (ß?=?1.135?×?10³, p?=?0.03) were predictors of low hip BMD.

Conclusion

Low BMD of the stroke-affected side hip is prevalent in over a third of individuals with lower limb motor impairments. These individuals may be at particular risk of accelerated loss of BMD at the hip from asymmetrical gait pattern and poor affected-side ankle dorsiflexor strength. These impairments are intervention targets that may be addressed during rehabilitation which includes resistance training and addresses gait impairments.     

Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective,double-blind,placebo-controlled study

Purpose

Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally immunostimulating agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

Methods

Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo.

Results

Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p = 0.59; PPS: p = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa.

Conclusions

This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated.

EudraCT

2007-004609-85.     

d-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trial

Purpose

To test whether d-mannose powder is effective for recurrent urinary tract infection (UTI) prevention.

Materials and methods

After initial antibiotic treatment of acute cystitis, 308 women with history of recurrent UTI and no other significant comorbidities were randomly allocated to three groups. The first group (n = 103) received prophylaxis with 2 g of d-mannose powder in 200 ml of water daily for 6 months, the second (n = 103) received 50 mg Nitrofurantoin daily, and the third (n = 102) did not receive prophylaxis.

Results

Overall 98 patients (31.8 %) had recurrent UTI: 15 (14.6) in the d-mannose group, 21 (20.4) in Nitrofurantoin group, and 62 (60.8) in no prophylaxis group, with the rate significantly higher in no prophylaxis group compared to active groups (P < 0.001). Patients in d-mannose group and Nitrofurantoin group had a significantly lower risk of recurrent UTI episode during prophylactic therapy compared to patients in no prophylaxis group (RR 0.239 and 0.335, P < 0.0001). In active groups, 17.9 % of patients reported side effects but they were mild and did not require stopping the prophylaxis. Patients in d-mannose group had a significantly lower risk of side effects compared to patients in Nitrofurantoin group (RR 0.276, P < 0.0001), but the clinical importance of this finding is low because Nitrofurantoin was well tolerated.

Conclusions

In our study, d-mannose powder had significantly reduced the risk of recurrent UTI which was no different than in Nitrofurantoin group. More studies will be needed to validate the results of this study, but initial findings show that d-mannose may be useful for UTI prevention.     

Improvement in intraoperative transcranial electrical motor-evoked potentials in tethered cord surgery: an analysis of 45 cases

Background

Improvement of transcranial electrical motor-evoked potentials (TeMEPs) following untethering during tethered cord surgery (TCS) and its clinical significance have not been analyzed in the literature.

Methods

Forty-five consecutive cases of tethered cord were operated on with multimodality intraoperative neurophysiological monitoring (IONM) between February 2005 and January 2012. Intraoperative TeMEP change was classified as improvement, worsening or no change. Motor, sensory, bladder and bowel symptoms and signs were evaluated preoperatively, in the first week post-surgery and at the last follow-up (maximum of 2 years).

Results

Patient age ranged from 5 to 44 years (mean, 16?±?10 years), with 30 children. Intraoperative MEPs improved in 23 (51 %), remained the same in 21 (46.7 %) and worsened in 1 (2 %) patient. Motor improvement occurred in 7 patients and clinical improvement in 17 patients in the immediate postoperative period. Postoperative neurological worsening occurred in one patient (2.2 %). Improved and stable MEPs correlated with the motor (p?=?0.002) and clinical improvement (p?=?0.02) in the immediate postoperative period. Follow-up was available in 35 patients (77.7 %), ranging from 5 to 24 months (median, 21 months; mean, 17.7?±?6.8 months). There was late clinical improvement in 73.5 % of the patients in whom the intraoperative MEP had remained the same or improved. However, there was no statistically significant correlation between MEP change and long-term outcome.

Conclusions

Intraoperative MEP improvement occurs in about 50 % of the patients following successful untethering. This finding probably provides support to the ischemic theory of tethered cord syndrome.     

Efficacy of home-based virtual cycling training on bone mineral density in ambulatory children with cerebral palsy

Summary

The 12-week home-based virtual cycling training (hVCT) improved lower limb muscle strength and areal bone mineral density (aBMD) than the control program in children with cerebral palsy (CP). A muscle strengthening program, rather than general physical activity, is more specific in enhancing aBMD for these children. A novel hVCT is an effective and efficient strategy that enhances lower limb bone density in these children.

Introduction

This is the first study to assess the efficacy of a novel hVCT program on bone density for children with spastic CP using a well-designed randomized controlled trial.

Methods

Twenty-seven ambulatory children with spastic CP, aged 6–12 years, were randomly assigned to the hVCT group (n?=?13) or control group (n?=?14). Outcome measures—motor function [Gross Motor Function Measure-66 (GMFM-66)], muscle strength (curl up scores and isokinetic torque of knee extensor and flexor muscle) and aBMD of the lumbar and distal femur—were administered before and immediately after the 12-week intervention.

Results

Analysis of covariance results show that the hVCT group had greater distal femur aBMD and isokinetic torques of knee extensor and flexor muscles than the control group at posttreatment (p?<?0.05). However, curl up scores, GMFM-66, and lumbar aBMD at posttreatment did not differ between the two groups.

Conclusions

Analytical findings suggest that the muscle strengthening program is more specific in enhancing bone density for children with CP than general physical activity. Thus, the proposed 12-week hVCT protocol is an effective and efficient strategy for improving lower limb aBMD in these children.