Evaluating repetitive transcranial magnetic stimulation for neurogenic overactive bladder management in stroke survivors: A randomized sham-controlled trial protocol.

BACKGROUND: Neurogenic overactive bladder (OAB) is a distressing condition in stroke. Existing neurogenic OAB management is expensive, unstandardized regimens, or invasive. Evaluating the effectiveness of repetitive transcranial magnetic stimulation (rTMS) remains crucial. We aimed to (1) compare the effectiveness of active-rTMS with sham-rTMS on neurogenic OAB symptoms, (2) analyze whether rTMS is cost-effective, and (3) explore the rTMS's experiences on participants' symptoms. METHODS: This is a randomized, sham-controlled, double-blinded trial with embedded qualitative and cost-effectiveness studies. A total of 110 stroke survivors with neurogenic OAB symptoms were screened for eligibility; 60 participants were eligible for inclusion and were randomly assigned to either the active (n = 30) or sham-rTMS (n = 30) groups using a computer-generated randomization schedule. The active-rTMS group received low-frequency rTMS of 1200 pulses per session lasting 20 min thrice weekly to pelvic floor muscle representation at the contralesional primary motor cortex. The sham-rTMS group received low-frequency stimulation at a 20 % resting motor threshold using the same coil as the active-rTMS but was configured to reduce the TMS-induced electrical fields significantly. The primary and secondary outcome measures were assessed at baseline, post-intervention (week 4) and follow-up (week 8). The analysis of covariance (ANCOVA) analysis compared changes in the study groups. Quality-adjusted life-years (QALY) were measured to evaluate the cost-effectiveness while EQ-5D-5L estimated QALY changes. Additionally, the focus group discussion data were thematically analyzed. CONCLUSIONS: The findings from this rTMS intervention study will be useful in alleviating neurogenic OAB symptoms and enhancing patient satisfaction in a cost-effective way.

Clinical tools for evaluating the severity of overactive bladder: A systematic review of psychometric properties.

OBJECTIVES: To systematically evaluate the evidence describing the psychometric properties of clinical measures for assessing overactive bladder symptoms (urinary urgency with or without urge urinary incontinence, urinary frequency and nocturia). To evaluate the quality of this evidence-base using the COnsensus-based Standards for selecting health status Measurement INstruments (COSMIN) checklist and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tools. DATA SOURCES: Five electronic databases (CINAHL, EMBASE, MEDLINE, Scopus and Web of Science) were searched from dataset inception to August 2023. REVIEW METHODS: Study screening, data extraction and quality appraisal were performed by two independent authors. Inclusion criteria were studies testing one or more psychometric properties of clinical tools for the assessment of overactive bladder symptoms among adults aged 18 years and older for both sexes. The methodological quality and quality of the evidence were evaluated using the COSMIN checklist and GRADE tools, respectively. RESULTS: The search identified 40 studies totalling 10,634 participants evaluating the psychometric properties of 15 clinical tools. The COSMIN methodological quality was rated good for most measures, and the GRADE quality of evidence ranged from low (13%) to high (33%). The Overactive Bladder Symptom Score, Overactive Bladder Questionnaire and Neurogenic Bladder Symptom Score were of good methodological and high-GRADE evidence qualities. CONCLUSION: Overactive Bladder Symptom Score, the Overactive Bladder Questionnaire and the Neurogenic Bladder Symptoms Score are promising psychometrically sound measures. The Overactive Bladder Symptom Score has been applied to the most culturally diverse populations supported by studies of good methodological and high-GRADE evidence quality.

Study protocol of a double-blind randomized control trial of transcranial direct current stimulation in post-stroke fatigue.

Rationale: Post-stroke fatigue (PSF) is a frequent problem in stroke survivors and often hinders their rehabilitation. PSF is difficult to treat, and pharmacological therapy is often ineffective. Transcranial direct current stimulation (tDCS) can modulate motor, sensory, cognitive and behavioral responses, as it alters neuronal activity by delivering a small amount of current via the scalp to the cortex, resulting in prolonged alterations to brain function. tDCS has been studied for the treatment of fatigue associated with other neurological diseases, namely, multiple sclerosis, Parkinson's disease and post-polio syndrome. Aims: This proposed project will examine the effect of tDCS on PSF. Sample size estimates: We will recruit 156 participants aged 18 to 80 with chronic stroke and allocate them equally to two groups (i.e., n = 78 per group). Methods and design: This proposed project will be a double-blind randomized control trial. The participants will be randomly divided into two groups. The control group will receive sham tDCS, and the treatment group will receive active tDCS. The latter treatment will involve application of a constant 2-mA current via one 5 × 5-cm anodal electrode positioned on the scalp over the C3 or C4 positions (motor cortex) of the lesioned hemisphere and one cathodal electrode positioned at the ipsilateral shoulder in two 20-min sessions per day for 5 days. The period of follow-up will be 4 weeks. Study outcomes: The primary outcome measure will be a change in fatigue severity, as measured using the modified fatigue impact scale (MFIS). The participants' scores on the MFIS (total score and physical, cognitive and psychosocial subscores) will be collected before treatment (T0), after 10 treatment sessions, i.e., 1 day after the fifth treatment day (T1), and 1 week (T2), 2 weeks (T3) and 4 weeks (T4) thereafter. Both per-protocol analysis and intention-to-treat analysis will be performed. Discussion: This proposed project will provide proof-of-concept, i.e., demonstrate the benefits of tDCS for the treatment of PSF. The beneficiaries are the subjects participated in the study. This will stimulate further research to optimize tDCS parameters for the treatment of PSF. Clinical trial registration: www.Chictr.org.cn, identifier: ChiCTR2100052515.

Effects of nonsurgical, minimally or noninvasive therapies for urinary incontinence due to neurogenic bladder: a systematic review and meta-analysis.

Objective: To determine the effects of nonsurgical, minimally or noninvasive therapies on urge urinary incontinence (UUI) symptoms and quality of life (QoL) in individuals with neurogenic bladder (NGB). Data Sources: Cochrane library, EMBASE, MEDLINE, PEDro, Scopus, and Web of Science databases were searched from inception to September 2021. Review Methods: Randomized controlled trials that compared therapies such as intravaginal electrical stimulation (IVES), transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), transcutaneous tibial nerve stimulation (TTNS), pelvic floor muscle training (PFMT), and behavioural therapy (BT) to control were included. Study screening, data extraction, and study quality assessments were performed by two independent authors. Results: Fourteen trials with 804 participants were included in the study after screening of 4281 potentially relevant articles. Meta-analyses revealed a significant effect of electrical stimulation on UUI due to multiple sclerosis (standardized mean difference (SMD): -0.614; 95% confidence interval (CI): -1.023, -0.206; p = 0.003) and stroke (SMD: -2.639; 95% CI: -3.804, -1.474; p = 0.000). The pooled analyses of TTNS (weighted mean difference (WMD): -12.406; 95% CI: -16.015, -8.797; p = 0.000) and BT (WMD: -9.117; 95% CI: -14.746, -3.487; p = 0.002) revealed significant effects of these interventions on QoL in people with Parkinson's disease. However, meta-analyses revealed nonsignificant effects for PFMT (WMD: -0.751; 95% CI: -2.426, 0.924; p = 0.380) and BT (WMD: -0.597; 95% CI: -1.278, 0.083; p = 0.085) on UUI due to Parkinson's disease. Conclusions: Our meta-analyses found electrical stimulation to be beneficial for improving the symptoms of UUI among people with multiple sclerosis and those with stroke. Our review also revealed that TTNS and BT might improve QoL for people with NGB due to Parkinson's disease, although the effects of PFMT and BT on UUI warrant further investigation.

Feasibility and Effects of Virtual Reality Motor-Cognitive Training in Community-Dwelling Older People With Cognitive Frailty: Pilot Randomized Controlled Trial.

BACKGROUND: Cognitive frailty refers to the coexistence of physical frailty and cognitive impairment, and is associated with many adverse health outcomes. Although cognitive frailty is prevalent in older people, motor-cognitive training is effective at enhancing cognitive and physical function. We proposed a virtual reality (VR) simultaneous motor-cognitive training program, which allowed older people to perform daily activities in a virtual space mimicking real environments. OBJECTIVE: We aimed to (1) explore the feasibility of offering VR simultaneous motor-cognitive training to older people with cognitive frailty and (2) compare its effects with an existing motor-cognitive training program in the community on the cognitive function and physical function of older people with cognitive frailty. METHODS: A two-arm (1:1), assessor-blinded, parallel design, randomized controlled trial was employed. The eligibility criteria for participants were: (1) aged ≥60 years, (2) community dwelling, and (3) with cognitive frailty. Those in the intervention group received cognitive training (ie, cognitive games) and motor training (ie, cycling on an ergometer) simultaneously on a VR platform, mimicking the daily living activities of older people. Those in the control group received cognitive training (ie, cognitive games) on tablet computers and motor training (ie, cycling on the ergometer) sequentially on a non-VR platform. Both groups received a 30-minute session twice a week for 8 weeks. Feasibility was measured by adherence, adverse outcomes, and successful learning. The outcomes were cognitive function, physical frailty level, and walking speed. RESULTS: Seventeen participants were recruited and randomized to either the control group (n=8) or intervention group (n=9). At baseline, the median age was 74.0 years (IQR 9.5) and the median Montreal Cognitive Assessment score was 20.0 (IQR 4.0). No significant between-group differences were found in baseline characteristics except in the number of chronic illnesses (P=.04). At postintervention, the intervention group (Z=-2.67, P=.01) showed a significantly larger improvement in cognitive function than the control group (Z=-1.19, P=.24). The reduction in physical frailty in the intervention group (Z=-1.73, P=.08) was similar to that in the control group (Z=-1.89, P=.06). Improvement in walking speed based on the Timed Up-and-Go test was moderate in the intervention group (Z=-0.16, P=.11) and greater in the control group (Z=-2.52, P=.01). The recruitment rate was acceptable (17/33, 52%). Both groups had a 100% attendance rate. The intervention group had a higher completion rate than the control group. Training was terminated for one participant (1/9, 11%) due to minimal VR sickness (Virtual Reality Sickness Questionnaire score=18.3/100). Two participants (2/8, 25%) in the control group withdrew due to moderate leg pain. No injuries were observed in either group. CONCLUSIONS: This study provides preliminary evidence that the VR simultaneous motor-cognitive training is effective at enhancing the cognitive function of older people with cognitive frailty. The effect size on frailty was close to reaching a level of significance and was similar to that observed in the control group. VR training is feasible and safe for older people with cognitive frailty. TRIAL REGISTRATION: ClinicalTrials.gov NCT04467216; https://clinicaltrials.gov/ct2/show/NCT04467216.

An Occupational Therapy Fall Reduction Home Visit Program for Community-Dwelling Older Adults in Hong Kong After an Emergency Department Visit for a Fall.

OBJECTIVES: To investigate the effects of an occupational therapy fall reduction home visit program for older adults admitted to the emergency department (ED) for a fall and discharged directly home. DESIGN: Single-blind, multicenter, randomized, controlled trial. SETTINGS: EDs in three acute care hospitals in Hong Kong. PARTICIPANTS: Individuals aged 65 and older who had fallen (N = 311). INTERVENTIONS: After screening for eligibility, 204 consenting individuals were randomly assigned to an intervention group (IG) and received a single home visit from an occupational therapist (OT) within 2 weeks after discharge from the hospital or a control group (CG) and received a well-wishing visit from a research assistant not trained in fall prevention. MEASUREMENTS: Both groups were followed for 12 months through telephone calls made every 2 weeks by blinded assessors with a focus on the frequency of falls. Another blinded assessor followed up on their status with telephone calls 4, 8, and 12 months after ED discharge. Prospective fall records on hospital admissions were retrieved from electronic databases; 198 individuals were followed for 1 year on an intention-to-treat basis. RESULTS: The percentage of fallers over 1 year was 13.7% in the IG (n = 95) and 20.4% in the CG (n = 103). There were significant differences in the number of fallers (P = .03) and the number of falls (P = .02) between the two groups over 6 months. Significant differences were found in survival analysis for first fall at 6 months (log-rank test 5.052, P = .02) but not 9 or 12 months. CONCLUSION: One OT visit after a fall was more effective than a well-wishing visit at reducing future falls at 6 months. A booster OT visit at 6 months is suggested.

Studies comparing the efficacy of constraint-induced movement therapy and bimanual training in children with unilateral cerebral palsy: a systematic review.

OBJECTIVE: To review studies comparing the efficacy of constraint-induced movement therapy (CIMT) and bimanual training (BIT) in improving the hemiplegic arm functioning and overall functional performance for children with unilateral cerebral palsy (CP). METHODS: Systematic searches of electronic databases, reference lists and journals identified seven studies that met pre-determined inclusion criteria. These studies were analysed in terms of participants, treatment activities and regime, outcome measures and results of intervention. RESULTS: Both CIMT and BIT produced similar improvements in the bimanual and unimanual capacities of the affected arm and overall functional performance. CONCLUSIONS: CIMT yields more improvements in the unimanual capacity of the impaired arm compared with BIT. A potential benefit of BIT is that participants may see more improvement in both bimanual performance and self-determined overall life goals. A combination of CIMT and BIT could be an option on improving arm function for children with unilateral CP in future.

Reliability and validity of the telephone version of the Cantonese Mini-mental State Examination (T-CMMSE) when used with elderly patients with and without dementia in Hong Kong.

BACKGROUND: The objectives of this study were to examine the reliability and validity of a 26-point telephone version of the Cantonese Mini-mental State Examination (T-CMMSE) for a sample of 65 elderly patients, comprising 31 patients without dementia and 34 patients with dementia, in an acute regional hospital in Hong Kong, and to identify an optimal cut-off score to discriminate between those patients with dementia and those without. METHODS: Participants were rated by using the face-to-face Mini-mental State Examination (MMSE) before inpatient discharge and the T-CMMSE after inpatient discharge, and were rated separately by two raters in two telephone follow-up sessions using the T-CMMSE. RESULTS: The results of the study indicated that the scale had excellent inter-and intra-rater reliabilities. There was substantial agreement between the two versions of the examination (kappa > 0.6-0.8 < or =) for orientation, registration, and recall items. An optimal cut-off score of < or = 16 was suggested for the T-CMMSE to discriminate between those with and without dementia. CONCLUSION: The T-CMMSE can be used in telephone follow-ups as an alternative to the conventional face-to-face version.