Heat and Acupuncture to Manage Osteoarthritis of the Knee (HARMOKnee): Protocol for an Effectiveness-Implementation Hybrid Randomized Controlled Trial.

BACKGROUND: Knee osteoarthritis (KOA) is one of most prevalent and fastest-growing causes of pain, impaired mobility, and poor quality of life in the rapidly aging population worldwide. There is a lack of high-quality evidence on the efficacy of traditional Chinese medicine (TCM), particularly acupuncture, and a lack of KOA practice guidelines that are tailored to unique population demographics and tropical climates. OBJECTIVE: Our HARMOKnee (Heat and Acupuncture to Manage Osteoarthritis of the Knee) trial aims to address these gaps by evaluating the short- and medium-term clinical and cost-effectiveness of acupuncture with heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, we aim to inform evidence-based practice for patients with KOA to facilitate the large-scale implementation of a comprehensive and holistic model of care that harmonizes elements of Western medicine and TCM. We hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone. METHODS: A multicenter, pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomized controlled trial will be conducted. We intend to recruit 100 patients with KOA randomized to either the control arm (standard care only) or intervention arm (acupuncture with heat therapy, in addition to standard care). The inclusion criteria are being a community ambulator and having primary KOA, excluding patients with secondary arthritis or previous knee replacements. The primary outcome measure is the Knee Osteoarthritis Outcome Score at 6 weeks. Secondary outcome measures include psychological, physical, quality of life, satisfaction, and global outcome measures at 6, 12, and 26 weeks. A mixed method approach through an embedded process evaluation will facilitate large-scale implementation. An economic evaluation will be performed to assess financial sustainability. RESULTS: Patient enrollment has been ongoing since August 2022. The recruitment process is anticipated to conclude by July 2024, and the findings will be analyzed and publicized as they are obtained. As of November 6, 2023, our patient enrollment stands at 65 individuals. CONCLUSIONS: The findings of our HARMOKnee study will contribute substantial evidence to the current body of literature regarding the effectiveness of acupuncture treatment for KOA. Additionally, we aim to facilitate the creation of standardized national guidelines for evidence-based practice that are specifically tailored to our unique population demographics. Furthermore, we seek to promote the adoption and integration of acupuncture and heat therapy into existing treatment models. TRIAL REGISTRATION: ClinicalTrials.gov NCT05507619; https://clinicaltrials.gov/study/NCT05507619. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54352.

Ultrasound Assessment of Changes in Muscle Architecture of the Brachialis Muscle After Stroke-A Prospective Study.

Objective: To investigate changes in ultrasound-derived muscle architecture parameters of the brachialis and correlations in patients with subacute stroke. Design: Prospective longitudinal observational study. Setting: Tertiary inpatient rehabilitation center. Participants: Fifty adult patients (N=50) who were recruited within the first month poststroke. The patients had a mean age of 57.2±12.3 years and 68.0% were male. The majority of patients had significant upper limb weakness with a low mean Motricity Index of 18.5±24.7 and median elbow flexor strength of grade 0. Intervention: Not applicable. Main Outcome Measures: Ultrasound of the intact and hemiparetic brachialis was performed at 3-time intervals: within 1 month of stroke onset and at 1 and 6 months after first assessment. Clinical variables captured included upper limb motor power and elbow flexor spasticity. Results: Compared to the intact brachialis, there was reduced muscle thickness (1.93 cm vs 2.07 cm, 1.86 cm vs 2.08 cm, 1.85 cm vs 2.05 cm; P=.022) and increased echo intensity (63.3 arbitrary units [AU] vs 56.8 AU, 69.4 AU vs 56.6 AU, 77.4 AU vs 58.2 AU; P<.001) in the hemiparetic brachialis at all assessment intervals (baseline, 1 month, 6 months). Reduction in muscle mass was greater in older patients, with the correlation coefficient ranging from -0.30 (P=.03) at baseline to -0.50 (P<.001) at 6 months. Presence of elbow flexor spasticity at 1-month assessment interval was associated with lower muscle mass reduction (1.93 cm vs 1.74 cm; P=.017), lower echo intensity (65.1 AU vs 75.1 AU; P=.023), and longer fascicle lengths (12.92 cm vs 9.83 cm; P=.002). Conclusions: Changes including decreased muscle thickness and increased echo intensity of the hemiparetic brachialis were noted over time. Elbow flexor spasticity at 1-month assessment interval appears to mitigate against these changes.

Burden of informal care in stroke survivors and its determinants: a prospective observational study in an Asian setting.

BACKGROUND: Informal caregiving is an integral part of post-stroke recovery with strenuous caregiving demands often resulting in caregiving burden, threatening sustainability of caregiving and potentially impacting stroke survivor's outcomes. Our study aimed to examine and quantify objective and subjective informal care burden after stroke; and to explore the factors associated with informal care burden in Singapore. METHODS: Stroke patients and their informal caregivers were recruited from all five tertiary hospitals in Singapore from December 2010 to September 2013. Informal care comprised of assistance provided by informal caregivers with any of the activities of daily living. Informal care burden was measured by patients' likelihood of requiring informal care, hours of informal care required, and informal caregivers' Zarit's Burden Score. We examined informal care burden at 3-months and 12-months post-stroke. Generalized linear regressions were applied with control variables including patients' and informal caregivers' demographic characteristics, arrangement of informal care, and patients' health status including stroke severity (measured using National Institute of Health Stroke Scale), functional status (measured using Modified Rankin Scale), self-reported depression, and common comorbidities. RESULTS: Three hundred and five patients and 263 patients were examined at 3-months and 12-months. Around 35% were female and 60% were Chinese. Sixty three percent and 49% of the patients required informal care at 3-months and 12-months point, respectively. Among those who required informal care, average hours required per week were 64.3 h at 3-months and 76.6 h at 12-months point. Patients with higher functional dependency were more likely to require informal care at both time points, and required more hours of informal care at 3-months point. Female informal caregivers and those caring for patients with higher functional dependency reported higher Zarit's Burden. While informal caregivers who worked full-time reported higher burden, those caring for married stroke patients reported lower burden at 3-months point. Informal caregivers who co-cared with foreign domestic workers, i.e.: stay-in migrant female waged domestic workers, reported lower burden. CONCLUSIONS: Informal care burden remains high up to 12-months post-stroke. Factors such as functional dependency, stroke severity, informal caregiver gender and co-caring with foreign domestic workers were associated with informal care burden.

Caregiver burden in familial caregivers and foreign domestic workers of patients with traumatic brain injury in a multi-ethnic Asian population.

OBJECTIVE: The purpose of this study was to investigate the prevalence and risk factors associated with caregiver burden in familial caregivers and foreign domestic workers of patients with severe traumatic brain injury. METHODS: A total of 77 caregivers were consecutively recruited, who were either familial caregivers or foreign domestic workers. All caregivers were evaluated with the Zarit Burden Index (ZBI), Patient Health Questionnaire-9 (PHQ-9), and General Anxiety Disorder 7-item (GAD-7) scale. Logistic regression analysis was conducted to determine factors associated with caregiver burden. RESULTS: The majority of participants were familial caregivers (N = 60), of which 70% experienced significant caregiver burden. In this group, 10.0% caregivers had clinically significant depression and 16.7% caregivers who had clinically significant anxiety. On multivariate analysis, factors found to be associated with caregiver burden were Glasgow Outcome Scale Extended (GOSE) of <7, presence of neuropsychiatric complications, and presence of anxiety. There was also a high prevalence of caregiver burden in foreign domestic workers (29.4%). CONCLUSION: There is a high rate of caregiver burden in both familial caregivers and foreign domestic workers who care for patients with severe traumatic brain injury. Caregivers experiencing stress should also be monitored for the presence of anxiety or depression.

The Validity of the Montreal Cognitive Assessment for Moderate to Severe Traumatic Brain Injury Patients: A Pilot Study.

OBJECTIVE: The aim of the study was to pilot the use of Montreal Cognitive Assessment as a quick clinical screen for cognitive assessment in traumatic brain injury patients. DESIGN: The study recruited 61 participants with moderate to severe traumatic brain injury presenting to a tertiary rehabilitation center under the Brain Injury Program. A Montreal Cognitive Assessment questionnaire and neuropsychological battery (Repeatable Battery for the Assessment of Neuropsychological Status and Color Trails Test) were administered to participants who had completed inpatient rehabilitation. RESULTS: Receiver operating characteristic analysis for the Montreal Cognitive Assessment revealed an optimal balance of sensitivity and specificity at 24/25 to discriminate participants who were classified as less than 5th centile on the Total Scale Index on the Repeatable Battery for the Assessment of Neuropsychological Status. This achieved a sensitivity, specificity, PPV, and NPV of 73.9%, 86.5%, 77.3%, and 84.2%, respectively. Receiver operating characteristic analysis for the trail making subtest of the Montreal Cognitive Assessment achieved a sensitivity, specificity, PPV, and NPV of 79.4%, 74.1%, 79.4%, and 74.1% in identifying patients classified as less than 5th centile on Color Trail Test part 2. CONCLUSIONS: The use of Montreal Cognitive Assessment displayed good validity in identifying patients with clinically significant impairment on a standard neuropsychological assessment battery in the study population. However, it may lack sensitivity for estimating mild levels of impairment.

Interview Functional Independence Measure score: self-reporting as a simpler alternative to multidisciplinary functional assessment.

INTRODUCTION: The Functional Independence Measure (FIM) is a validated, objective assessment of functional status. It is widely used in rehabilitation centres but may not be practical for all patients due to time and/or personnel constraints. Studies show positive and negative agreement on self-reported FIM scores for patients with spinal cord injuries and amputees. We tested the validity of the self-reported FIM motor score among stroke patients. METHODS: We conducted a prospective double-blind comparative study of patient self-reporting against multidisciplinary assessment, using the standard FIM algorithm. All eligible stroke patients (n = 47) admitted to our rehabilitation centre were included. 33 patients were included in the final analysis. RESULTS: There was substantial agreement on overall FIM motor score between patient self-reporting and multidisciplinary assessment (intraclass correlation coefficient [ICC] 0.651, 95% confidence interval 0.404-0.811). The scores of individual motor items also showed fair-to-good agreement (ICC range 0.431-0.618), except for eating, grooming, bathing and dressing of the lower body (ICC < 0.400). CONCLUSION: There was no FIM assessment for 14 (29.8%) patients, highlighting the need for alternative assessment tools. Discrepancies in some scores could be due to patients' ignorance of their own limitations or feelings of embarrassment about reporting. Our results may not be valid for patient populations with cognitive or communication deficits. However, a modest agreement between patient self-reporting and multidisciplinary assessment of FIM motor score was demonstrated. Although patients tend to overrate their performance, self-reported FIM motor scores could be an alternative in situations where multidisciplinary FIM assessment is difficult.

Countrywide stroke incidence, subtypes, management and outcome in a multiethnic Asian population: the Singapore Stroke Registry--methodology.

RATIONALE: Because of its rapidly-growing and aging populations, the global burden of stroke will be felt most strongly in Asia. Data from Asia are scarce. Even rarer are data from multiethnic populations. AIM: The Singapore Stroke Registry is a countrywide registry of risk factors, stroke subtypes, management and outcome of incident and recurrent stroke in multiethnic Singapore. METHODS AND DESIGN: Using a cold-pursuit design, potential subjects are identified from medical claims, hospital discharge summaries and death certificates. Standardized methods are used for case ascertainment and data recording by trained staff into standardized case report forms. All ages and both genders are included. STUDY OUTCOME: Stroke incidence, subtypes and mortality will be calculated. Trend data will be obtained. Inter-ethnic differences will be explored. DISCUSSION: The Registry has many features of an 'ideal' incidence study. Previously unavailable countrywide data on an Asian population will be acquired. The unique data on inter-ethnic differences will help fill knowledge gaps in stroke epidemiology.

Characteristics and correlates of rehabilitation charges during inpatient traumatic brain injury rehabilitation in Singapore.

OBJECTIVES: A prospective study of 91 consecutive traumatic brain injury admissions to rehabilitation over a 2-year period to determine factors impacting on rehabilitation charges. METHODS: Discharge records of 91 adult traumatic brain injury patients comprising total unsubsidized billings for each completed inpatient rehabilitation episode were used to derive total charges. Co-variates analysed included demographic, acute traumatic brain injury and rehabilitation variables including the Modified Barthel Index score. RESULTS: The total median rehabilitation charge per episode was S$7845.50 (range: S$970.55-$44,817.20) [1 Euro=S$2.10]. The top 3 contributory median total charges/episode included bed, board and nursing (S$5616.00), occupational therapy (S$606.00), and physical therapy (S$526.00). Patients with lower admission Glasgow Coma Scale scores, longer post-traumatic amnesia duration, dysphagia and medical complications during rehabilitation, lower admission Modified Barthel Index scores, longer acute and rehabilitation length of stay had significantly higher rehabilitation charges (p<0.001). Using multiple regression analyses, only rehabilitation length of stay and change in Modified Barthel Index were significantly correlated with total rehabilitation charges (p<0.001). DISCUSSION: Measures to reduce rehabilitation length of stay, to prevent medical complications, to facilitate transfers to rehabilitation, and expedient discharge planning may help to reduce rehabilitation charges. CONCLUSION: This study has potential implications for healthcare resource planning for traumatic brain injury rehabilitation.