Randomized Controlled Trials as Topic
Research Papers
Showing 6 of 12Effects of occupational therapy on quality of life in breast cancer patients: A systematic review and meta-analysis
BACKGROUND: The objective was to discuss the impact of occupational therapy on different domains of quality of life in breast cancer patients. We performed a literature search to identify articles published before June 27, 2023, using the following databases: PubMed, Embase, Web of Science, Cochrane Library, and Scopus. OBJECTIVE: The objective was to discuss the impact of occupational therapy on different domains of quality of life in breast cancer patients. DATA SOURCES: We performed a literature search to identify articles published before June 27, 2023, using the following databases: PubMed, Embase, Web of Science, Cochrane Library, and Scopus. METHODS: This study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomized controlled trials that reported the effects of occupational therapy on quality of life in breast cancer patients were identified. Two reviewers independently assessed eligibility, extracted data, and determined risks of bias. Pooled standardized mean differences (SMDs) with 95% confidence intervals (CIs) were estimated using random-effects meta-analyses. Galbraith plots, meta-regression analysis, subgroup analysis, and sensitivity analysis were used to identify heterogeneity in treatment effects. RESULTS: Eight studies were included, with a total of 543 patients. The experimental group exhibited better global health (pooled SMD = 0.640, 95% CI = 0.251-1.028, P = .001), physical health (pooled SMD = 0.640, 95% CI = 0.251-1.028, P = .019), social health (pooled SMD = 0.251, 95% CI = 0.011-0.490, P = .040), and cognitive function (pooled SMD = 0.863, 95% CI = 0.266-1.460, P = .05) and improve fatigue (pooled SMD = -0.389, 95% CI = -0.586 to -0.192, P = .000), and role function (pooled SMD = 0.287, 95% CI = 0.029-0.546, P = .029) than the control group. The 2 groups exhibited comparable emotional health (pooled SMD = 0.243, 95% CI = -0.051 to 0.536, P = .105) and pain (pooled SMD = -0.312, 95% CI = -0.660 to 0.036, P = .079). CONCLUSION: The current evidence shows that occupational therapy can improve the quality of life of breast cancer patients, especially their global health, physical health, social health, cognitive function, fatigue, and role function.
View Full Paper →Interventions for perceptual disorders following stroke
BACKGROUND: Perception is the ability to understand information from our senses. It allows us to experience and meaningfully interact with our environment. A stroke may impair perception in up to 70% of stroke survivors, leading to distress, increased dependence on others, and poorer quality of life. Interventions to address perceptual disorders may include assessment and screening, rehabilitation, non-invasive brain stimulation, pharmacological and surgical approaches. OBJECTIVES: To assess the effectiveness of interventions aimed at perceptual disorders after stroke compared to no intervention or control (placebo, standard care, attention control), on measures of performance in activities of daily living. SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group, CENTRAL, MEDLINE, Embase, and three other databases to August 2021. We also searched trials and research registers, reference lists of studies, handsearched journals, and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of adult stroke survivors with perceptual disorders. We defined perception as the specific mental functions of recognising and interpreting sensory stimuli and included hearing, taste, touch, smell, somatosensation, and vision. Our definition of perception excluded visual field deficits, neglect/inattention, and pain. DATA COLLECTION AND ANALYSIS: One review author assessed titles, with two review authors independently screening abstracts and full-text articles for eligibility. One review author extracted, appraised, and entered data, which were checked by a second author. We assessed risk of bias (ROB) using the ROB-1 tool, and quality of evidence using GRADE. A stakeholder group, comprising stroke survivors, carers, and healthcare professionals, was involved in this review update. MAIN RESULTS: We identified 18 eligible RCTs involving 541 participants. The trials addressed touch (three trials, 70 participants), somatosensory (seven trials, 196 participants) and visual perception disorders (seven trials, 225 participants), with one (50 participants) exploring mixed touch-somatosensory disorders. None addressed stroke-related hearing, taste, or smell perception disorders. All but one examined the effectiveness of rehabilitation interventions; the exception evaluated non-invasive brain stimulation. For our main comparison of active intervention versus no treatment or control, one trial reported our primary outcome of performance in activities of daily living (ADL): Somatosensory disorders: one trial (24 participants) compared an intervention with a control intervention and reported an ADL measure. Touch perception disorder: no trials measuring ADL compared an intervention with no treatment or with a control intervention. Visual perception disorders: no trials measuring ADL compared an intervention with no treatment or control. In addition, six trials reported ADL outcomes in a comparison of active intervention versus active intervention, relating to somatosensation (three trials), touch (one trial) and vision (two trials). AUTHORS' CONCLUSIONS: Following a detailed, systematic search, we identified limited RCT evidence of the effectiveness of interventions for perceptual disorders following stroke. There is insufficient evidence to support or refute the suggestion that perceptual interventions are effective. More high-quality trials of interventions for perceptual disorders in stroke are needed. They should recruit sufficient participant numbers, include a 'usual care' comparison, and measure longer-term functional outcomes, at time points beyond the initial intervention period. People with impaired perception following a stroke should continue to receive neurorehabilitation according to clinical guidelines.
View Full Paper →Real-time fMRI neurofeedback as a new treatment for psychiatric disorders: A meta-analysis
Neurofeedback using real-time functional MRI (RT-fMRI-NF) is an innovative technique that allows to voluntarily modulate a targeted brain response and its associated behavior. Despite promising results in the current literature, its effectiveness on symptoms management in psychiatric disorders is not yet clearly demonstrated. Here, we provide 1) a state-of-art qualitative review of RT-fMRI-NF studies aiming at alleviating clinical symptoms in a psychiatric population; 2) a quantitative evaluation (meta-analysis) of RT-fMRI-NF effectiveness on various psychiatric disorders and 3) methodological suggestions for future studies. Thirty-one clinical trials focusing on psychiatric disorders were included and categorized according to standard diagnostic categories. Among the 31 identified studies, 22 consisted of controlled trials, of which only eight showed significant clinical improvement in the experimental vs. control group after the training. Nine studies found an effect at follow-up on ADHD symptoms, emotion dysregulation, facial emotion processing, depressive symptoms, hallucinations, psychotic symptoms, and specific phobia. Within-group meta-analysis revealed large effects of the NF training on depressive symptoms right after the training (g = 0.81, p < 0.01) and at follow-up (g = 1.19, p < 0.01), as well as medium effects on anxiety (g = 0.44, p = 0.01) and emotion regulation (g = 0.48, p < 0.01). Between-group meta-analysis showed a medium effect on depressive symptoms (g = 0.49, p < 0.01) and a large effect on anxiety (g = 0.77, p = 0.01). However, the between-studies heterogeneity is very high. The use of RT-fMRI-NF as a treatment for psychiatric symptoms is promising, however, further double-blind, multicentric, randomized-controlled trials are warranted.
View Full Paper →Clinical Effects of Immersive Multimodal BCI-VR Training after Bilateral Neuromodulation with rTMS on Upper Limb Motor Recovery after Stroke. A Study Protocol for a Randomized Controlled Trial
Background and Objectives: The motor sequelae after a stroke are frequently persistent and cause a high degree of disability. Cortical ischemic or hemorrhagic strokes affecting the cortico-spinal pathways are known to cause a reduction of cortical excitability in the lesioned area not only for the local connectivity impairment but also due to a contralateral hemisphere inhibitory action. Non-invasive brain stimulation using high frequency repetitive magnetic transcranial stimulation (rTMS) over the lesioned hemisphere and contralateral cortical inhibition using low-frequency rTMS have been shown to increase the excitability of the lesioned hemisphere. Mental representation techniques, neurofeedback, and virtual reality have also been shown to increase cortical excitability and complement conventional rehabilitation. Materials and Methods: We aim to carry out a single-blind, randomized, controlled trial aiming to study the efficacy of immersive multimodal Brain-Computer Interfacing-Virtual Reality (BCI-VR) training after bilateral neuromodulation with rTMS on upper limb motor recovery after subacute stroke (>3 months) compared to neuromodulation combined with conventional motor imagery tasks. This study will include 42 subjects in a randomized controlled trial design. The main expected outcomes are changes in the Motricity Index of the Arm (MI), dynamometry of the upper limb, score according to Fugl-Meyer for upper limb (FMA-UE), and changes in the Stroke Impact Scale (SIS). The evaluation will be carried out before the intervention, after each intervention and 15 days after the last session. Conclusions: This trial will show the additive value of VR immersive motor imagery as an adjuvant therapy combined with a known effective neuromodulation approach opening new perspectives for clinical rehabilitation protocols.
View Full Paper →Non-Pharmacological Management of Painful Peripheral Neuropathies: A Systematic Review
INTRODUCTION: Peripheral neuropathic pain (PNP) is defined as the neuropathic pain that arises either acutely or in the chronic phase of a lesion or disease affecting the peripheral nervous system. PNP is associated with a remarkable disease burden, and there is an increasing demand for new therapies to be used in isolation or combination with currently available treatments. The aim of this systematic review was to evaluate the current evidence, derived from randomized controlled trials (RCTs) that assess non-pharmacological interventions for the treatment of PNP. METHODS: After a systematic Medline search, we identified 18 papers eligible to be included. RESULTS: The currently best available evidence (level II of evidence) exist for painful diabetic peripheral neuropathy. In particular, spinal cord stimulation as adjuvant to conventional medical treatment can be effectively used for the management of patients with refractory pain. Similarly, adjuvant repetitive transcranial magnetic stimulation of the motor cortex is effective in reducing the overall pain intensity, whereas adjuvant static magnetic field therapy can lead to a significant decrease in exercise-induced pain. Weaker evidence (level III of evidence) exists for the use of acupuncture as a monotherapy and neurofeedback, either as an add-on or a monotherapy approach, for treatment of painful chemotherapy-induced peripheral neuropathy CONCLUSIONS: Future RCTs should be conducted to shed more light in the use of non-pharmacological approaches in patients with PNP.
View Full Paper →Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial
BACKGROUND: Older adults with Mild Cognitive Impairment (MCI) are at high risk of progressing to Alzheimer's disease (AD). Slowing down the effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback (NF) has shown promising results in improving working memory but has never been evaluated in people with MCI. We aim to examine whether NF training can decrease cognitive disorders, targeting memory, attention functions and brain electrical activity in elderly patients with MCI. METHODS: In this single-blind, randomized controlled trial (RCT) protocol, we will investigate the effects of two NF training protocols on cognitive performances and on brain electrical activity. Sixty MCI patients will be assigned either to an intervention program or to psycho-pedagogical care as a control condition. Participants in the intervention group will attend 30 sessions of sensorimotor/delta-ratio NF training or beta1/theta-ratio NF training. Neuropsychological assessment, questionnaires and electroencephalography (EEG) assessment parameters will be used as dependent variables in three periods: at baseline (T0), immediately after the last NF training session at 4 months (T1) and at 3-month follow-up (T2). The primary outcome will be the change in attention measured with the Trail Making Test B. Secondary outcome will be the changes in cognitive performance and in EEG activities. DISCUSSION: If the results of our study show improvement in cognitive performances of older adults with MCI, this non-invasive, low-cost technique may deserve better consideration as a therapeutic intervention to delay cognitive decline and dementia. Consequently, research in NF will need to review and develop the rigor of its application in gerontology. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03526692 . Registered on 16 May 2018.
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