Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial.

BACKGROUND: After discharge from hospital following a stroke, prescriptions of community-based rehabilitation are often downgraded to "maintenance" rehabilitation or discontinued. This classic therapeutic behavior stems from persistent confusion between lesion-induced plasticity, which lasts for the first 6 months essentially, and behavior-induced plasticity, of indefinite duration, through which intense rehabilitation might remain effective. This prospective, randomized, multicenter, single-blind study in subjects with chronic stroke-induced hemiparesis evaluates changes in active function with a Guided Self-rehabilitation Contract vs conventional therapy alone, pursued for a year. METHODS: One hundred and twenty four adult subjects with chronic hemiparesis (> 1 year since first stroke) will be included in six tertiary rehabilitation centers. For each patient, two treatments will be compared over a 1-year period, preceded and followed by an observational 6-month phase of conventional rehabilitation. In the experimental group, the therapist will implement the diary-based and antagonist-targeting Guided Self-rehabilitation Contract method using two monthly home visits. The method involves: i) prescribing a daily antagonist-targeting self-rehabilitation program, ii) teaching the techniques involved in the program, iii) motivating and guiding the patient over time, by requesting a diary of the work achieved to be brought back by the patient at each visit. In the control group, participants will benefit from conventional therapy only, as per their physician's prescription. The two co-primary outcome measures are the maximal ambulation speed barefoot over 10 m for the lower limb, and the Modified Frenchay Scale for the upper limb. Secondary outcome measures include total cost of care from the medical insurance point of view, physiological cost index in the 2-min walking test, quality of life (SF 36) and measures of the psychological impact of the two treatment modalities. Participants will be evaluated every 6 months (D1/M6/M12/M18/M24) by a blinded investigator, the experimental period being between M6 and M18. Each patient will be allowed to receive any medications deemed necessary to their attending physician, including botulinum toxin injections. DISCUSSION: This study will increase the level of knowledge on the effects of Guided Self-rehabilitation Contracts in patients with chronic stroke-induced hemiparesis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02202954 , July 29, 2014.

Sacral neuromodulation and pregnancy: Results of a national survey carried out for the neuro-urology committee of the French Association of Urology (AFU).

AIMS: To assess the impact of sacral neuromodulation (SNM) on pregnancy and vice-versa, by identifying women who had received SNM for lower-urinary tract symptoms (LUTS) and had become pregnant. METHODS: A cross-sectional descriptive study was carried out based on responses to an on-line questionnaire sent to practitioners listed on the InterStim enCaptureTM National Registry. Questions were related to pre-pregnancy health and SNM efficacy, deactivation of the device, its impact on LUTS, childbirth, the infant, its reactivation and postpartum effectiveness. RESULTS: Twenty-seven pregnancies were recorded among 21 women. Six women had had a pregnancy prior to implantation, two of whom had had a c-section. A total of 18.5% of women had the device disabled prior to conception. The others had their device disabled during the first trimester and did not reactivate it before delivery. Complications were reported in 25.9% of pregnancies: six women had urinary infections, including three of the four treated for chronic retention of urine (CRU), and 1 woman had pain at the stimulation site. There were 24 live births (including one premature birth and four c-sections), one spontaneous miscarriage and two voluntary interruptions of pregnancy. No neonatal disorders have been reported. Effectiveness of sacral neuromodulation decreased in 20% in postpartum. CONCLUSIONS: In 27 pregnancies established during SNM for LUTS, 18.5% of patients deactivated their case before pregnancy and the others switched it off during the first trimester. Three-quarters of women with CRU had urinary infection. No adverse effects on fetuses were found. SNM effectiveness deteriorated in 20% cases after childbirth.

Comprehensive evaluation of embarrassment and pain associated with invasive urodynamics.

AIMS: To evaluate pain and embarrassment associated with invasive urodynamics and to determine underlying factors. METHODS: One hundred seventy one consecutive patients referred to our department for invasive urodynamics were evaluated using visual numeric rating scales for sensations of apprehension, pain, and embarrassment during several steps of the procedure (scores ranging from 0 [no symptom] to 10 [worst imaginable symptom]). We also investigated the influence of sex, age, information provided before urodynamics, and medical indication on these sensations. The Spearman correlation, non-parametric test, and logistic regression analysis were performed to determine explicative factors for the most painful sensations. RESULTS: The mean age was 61.0 (standard deviation ± 15 years). The mean (95% confidence interval [CI]) apprehension level was 2.9/10 (2.4; 3.4). The mean (95% CI) pain levels at installation on urodynamic table, transurethral catheter insertion (cystometry), and catheter repositioning (urethral pressure profilometry) were 0.3/10 (0.1; 0.5), 1.9/10 (1.6; 2.3), and 1.3/10 (1.0; 1.7), respectively. At catheter insertion, 25% of patients reported a pain level ≥ 4/10. The mean embarrassment level due to urination in front of the doctor was 1.9/10 (1.4; 2.3). Painful sensations reported during the different steps were strongly correlated with each other and with levels of apprehension and embarrassment. Age <54 years (lower quartile) and apprehension level were the only factors associated with painful sensation. CONCLUSIONS: Our study confirms that invasive urodynamics is a well-tolerated procedure. However, some patients experience high levels of pain and embarrassment throughout the procedure. Younger age and apprehension were the most influential factors.

Evaluation of urinary symptoms in patients with post-prostatectomy urinary incontinence treated with the male sling TOMS.

AIMS: To evaluate stress urinary incontinence (SUI), overactive bladder (OAB), and obstructive symptoms in patients with post-radical prostatectomy urinary incontinence (pRP-UI) treated with the bulbar compressive sling TOMS, and investigate the effect of each urinary symptom on urinary bother. MATERIALS AND METHODS: We prospectively followed 40 patients with pRP-UI before, and 6 and 12 months (T6 and T12, respectively) after implantation of the TOMS sling. Urinary symptoms were evaluated using the following questionnaires: USP, ICIQ, UCLA-PCI (urinary bother domain), PGI-I, and daily pad use. Success was defined as patients wearing no pads or using one security pad. RESULTS: Significant improvement of mean USP-SUI (6.97/9, 3.35, 3.02, P < 0.001) and USP-OAB domains (8.1/21, 5.74, 5.71, P < 0.001), ICIQ (15.15/21, 8.17/21, 8.35/21, P < 0.01), urinary bother (92.5/100, 42.5, 41.87, P < 0.001), and pad number (2.78, 1.01, 1.03, P < 0.001) were noted between baseline, T6, and T12. At baseline, 32 (80%) patients reported urge incontinence. Urinary bother strongly correlated with UPS-SUI but not with UPS-OAB score. At T12, 22 (55%) patients with pad use were considered cured, and 13 (32.5%) patients reported a greatly improved urinary tract condition (PGI-I). Improvement of USP-SUI and USP-OAB scores correlated with improvement of ICIQ and PGI scores. The USP-obstructive domain remained unchanged. CONCLUSION: The TOMS sling improves SUI and OAB symptoms without generating obstructive symptoms. OAB symptoms including urge incontinence reported by most patients were not a major concern at baseline; however, improvement of these symptoms was associated with improvement of continence and PGI-I scores.

Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Cell therapy using muscle precursor cell (MPC) injections has shown promise for urinary incontinence due to intrinsic sphincter deficiency (ISD), but the cell-preparation process is complex and costly. Implantation of freshly isolated myofibres carrying MPCs, mainly satellite cells, was very efficient in repairing muscle damage in recent animal experiments. In a phase I clinical trial, we investigated whether periurethral myofibre implantation generated local myogenesis and improved continence in 10 patients (five men and five women) with ISD. We found that myofibre implantation increased intraurethral pressure and periurethral electromyographic activity in patients with ISD. There were no serious side-effects. OBJECTIVES: To assess the safety of periurethral myofibre implantation in patients with urinary incontinence due to intrinsic sphincter deficiency (ISD) To assess the resulting myogenic process and effects on urinary continence. PATIENTS AND METHODS: An open-label non-randomised phase I clinical trial was conducted in five men and five women with ISD (mean age, 62.5 years). A free muscle strip from the patient's gracilis muscle was implanted around the urethra as a means to deliver locally myofibres and muscle precursor cells (MPCs). Patients were assessed for collection formation and incomplete bladder emptying. The maximum urethral closure pressure (MUCP) and concomitant periurethral electromyographic (EMG) activity were recorded before surgery and 1 and 3 months after surgery. Continence was assessed using the 24-h pad test and self-completed questionnaires, for 12 months. RESULTS: There were no serious side-effects. Continence improved significantly during the 12-month follow-up in four of the five women, including two who recovered normal continence. In the women, MUCP increased two-fold and de novo EMG periurethral activity was recorded. In the men, MUCP and EMG recordings showed similar improvements but the effect on continence was moderate. The few patients enrolled could affect these results. CONCLUSIONS: This is the first report of a one-step procedure for transferring autologous MPCs via myofibre implantation in patients with ISD. EMG and urodynamic assessments showed improvement of periurethral muscle activity. Further work is needed to confirm and improve the therapeutic efficiency of this procedure.

Agonist and antagonist activation at the ankle monitored along the swing phase in hemiparetic gait.

BACKGROUND: Descending command in hemiparesis is reduced to agonists and misdirected to antagonists. We monitored agonist and antagonist activation along the swing phase of gait, comparing paretic and non-paretic legs. METHODS: Forty-two adults with chronic hemiparesis underwent gait analysis with bilateral EMG from tibialis anterior, soleus and gastrocnemius medialis. We monitored ankle and knee positions, and coefficients of agonist activation in tibialis anterior and of antagonist activation in soleus and gastrocnemius medialis over the three thirds of swing phase. These coefficients were defined as the ratio of the root-mean-square EMG from one muscle over any period to the root-mean-square EMG from the same muscle over 100 ms of its maximal voluntary isometric contraction. FINDINGS: As against the non-paretic side, the paretic side showed lesser ankle dorsiflexion and knee flexion (P < 1.E-5), with higher coefficients of agonist activation in tibialis anterior (+100 ± 28%, P < 0.05), and of antagonist activation in soleus (+224 ± 41%, P < 0.05) and gastrocnemius medialis (+276 ± 49%, P < 0.05). On the paretic side, coefficient of agonist activation in tibialis anterior decreased from mid-swing on; coefficients of antagonist activation in soleus and gastrocnemius medialis increased and ankle dorsiflexion decreased in late swing (P < 0.05). INTERPRETATION: During the swing phase in hemiparesis, normalized tibialis anterior recruitment is higher on the paretic than on the non-paretic leg, failing to compensate for a marked increase in plantar flexor activation (cocontraction). The situation deteriorates along swing with a decrease in tibialis anterior recruitment in parallel with an increase in plantar flexor activation, both likely related to gastrocnemius stretch during knee re-extension. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT03119948.

Intra- and inter-rater reliability of the 10-meter ambulation test in hemiparesis is better barefoot at maximal speed.

Objectives Reliability of clinical tests to evaluate ambulation in chronic hemiparesis may vary according to the testing condition. The 10-meter ambulation test (AT10) assesses walking speed and step length over 10 m, starting and ending in seated position. In the present study, we compared the intra- and inter-reliability of AT10 in chronic hemiparesis in four different conditions: with shoes and barefoot, at free and maximal safe speed. Methods Ten patients with hemiparesis, >1 year post-stroke (age 45 ± 12, time since stroke 16 ± 9 months, mean ± SD) participated in the reliability study (registration, ID-RCB-2017-A00090-53). All patients performed the AT10 twice, one week apart, in each of the four conditions. The number of steps and time to complete the task were manually recorded by four independent raters. The main outcome measurements were the intraclass correlation coefficients (ICC), coefficients of variation (CV), and mean raw differences (DIFF) of the three parameters of AT10 (speed, step length, and cadence) in each of the four conditions. Effects of wearing shoes and speed condition were explored using ANOVA. Results Across all conditions, mean intra- and inter-rater ICCs were, respectively, 98.5 ± 0.1 and 99.9 ± 0.1% for speed, 98.3 ± 0.1 and 99.7 ± 0.2% for step length, and 96.5 ± 0.1 and 98.9 ± 0.6% for cadence. Mean intra- and inter-rater CV for speed were 0.051 ± 0.016 and 0.022 ± 0.002, respectively. Intra-rater reliability of speed assessments was higher at maximal than at free speed (ICC, CV, DIFF, p < 0.05). At free speed, intra-rater ICCs were higher barefoot than with shoes (p < 0.05). Discussion Performing the 10-meter ambulation test barefoot at maximal speed optimizes its reliability.

Association between hand hygiene compliance and methicillin-resistant Staphylococcus aureus prevalence in a French rehabilitation hospital.

We simultaneously investigated the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) and compliance with hand hygiene in the clinical wards of a French rehabilitation hospital. We found that the rate of hand hygiene compliance observed at the patient's bedside was a strong predictor of MRSA prevalence.