scholarly journals A randomised clinical trial comparing 35 Hz versus 50 Hz frequency stimulation effects on hand motor recovery in older adults after stroke

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Trinidad Sentandreu-Mañó ◽  
José M. Tomás ◽  
J. Ricardo Salom Terrádez
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Neuromuscular Electrical Stimulation ◽  
Motor Impairment ◽  
Randomised Clinical Trial ◽  
Motor Recovery ◽  
Pinch Strength ◽  
Control Group ◽  
Specific Stimulation ◽  
And Function

AbstractMore solid data are needed regarding the application of neuromuscular electrical stimulation (NMES) in the paretic hand following a stroke. A randomised clinical trial was conducted to compare the effects of two NMES protocols with different stimulation frequencies on upper limb motor impairment and function in older adults with spastic hemiparesis after stroke. Sixty nine outpatients were randomly assigned to the control group or the experimental groups (NMES with 50 Hz or 35 Hz). Outcome measures included motor impairment tests and functional assessment. They were collected at baseline, after 4 and 8 weeks of treatment, and after a follow-up period. NMES groups showed significant changes (p < 0.05) with different effect sizes in range of motion, grip and pinch strength, the Modified Ashworth Scale, and the muscle electrical activity in the extensors of the wrist. The 35 Hz NMES intervention showed a significant effect on Barthel Index. Additionally, there were no significant differences between the groups in the Box and Block Test. Both NMES protocols proved evidence of improvements in measurements related to hand motor recovery in older adults following a stroke, nevertheless, these findings showed that the specific stimulation frequency had different effects depending on the clinical measures under study.

scholarly journals Double-task exercise programmes to strengthen cognitive and vascular health in older adults at risk of cognitive decline: protocol for a randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039723
Author(s):  
Rosalinda Sánchez-Arenas ◽  
Svetlana V Doubova ◽  
Mariela Bernabe-Garcia ◽  
Michel A Gregory ◽  
Laura Alejandra Mejía-Alonso ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
At Risk ◽  
Cognitive Decline ◽  
Randomised Clinical Trial ◽  
Outcome Variable ◽  
Control Group ◽  
Study Results ◽  
Registration Number ◽  
Exercise Programmes

IntroductionCognitive and physical declines are frequent causes of disability among older adults (OAs) in Mexico that imposes significant burden on the health system and OAs’ families. Programmes to prevent or delay OAs’ cognitive and physical decline are scarce.Methods and analysisA double-blind randomised clinical trial will be conducted. The study will aim to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programmes for OAs at risk of cognitive decline—one programme with and another without caregiver participation—and to compare these with an aerobic-balance-stretching exercise programme (control group). 300 OAs (100 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 65 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups. The intervention will last 24 weeks, and the effect of each programme will be evaluated 12, 24 and 52 weeks after the intervention. Participants’ demographic and clinical characteristics will be collected at baseline. The outcomes will include: (1) general cognitive function; (2) specific cognitive functions; (3) dual-task gait; (4) blood pressure; (5) carotid intima–media thickness; (6) OAs’ health-related quality of life; and (7) caregiver burden. The effects of the interventions on each outcome variable will be examined using a repeated-measures analysis of variance (ANOVA), with study groups as the between-subjects variable and time as the within-subject variable.Ethics and disseminationThe study was approved by the IMSS Ethics and Research Committees (registration number: 2018-785-095). All participants will sign a consent form prior to their participation. The study results will be disseminated to the IMSS authorities, healthcare providers and the research community.Trial registration numberClinicalTrials.gov (NCT04068376).

scholarly journals Older Adults’ Experiences of a Physical Activity and Sedentary Behaviour Intervention: A Nested Qualitative Study in the SITLESS Multi-Country Randomised Clinical Trial

2021 ◽  
Vol 18 (9) ◽  
pp. 4730
Author(s):  
Nicole Blackburn ◽  
Mathias Skjodt ◽  
Mark Tully ◽  
Ilona Mc Mullan ◽  
Maria Giné-Garriga ◽  
...  
Keyword(s):  
Older Adults ◽  
Social Interaction ◽  
Qualitative Study ◽  
Management Strategies ◽  
Randomised Clinical Trial ◽  
Control Group ◽  
Individual Interviews ◽  
Perceived Effects ◽  
Qualitative Methodologies ◽  
Exercise Referral

Background: The SITLESS programme comprises exercise referral schemes and self-management strategies and has been evaluated in a trial in Denmark, Spain, Germany and Northern Ireland. The aim of this qualitative study was to understand the implementation and contextual aspects of the intervention in relation to the mechanisms of impact and to explore the perceived effects. Methods: Qualitative methodologies were nested in the SITLESS trial including 71 individual interviews and 12 focus groups targeting intervention and control group participants from postintervention to 18-month follow-up in all intervention sites based on a semi-structured topic guide. Results: Overarching themes were identified under the framework categories of context, implementation, mechanisms of impact and perceived effects. The findings highlight the perceived barriers and facilitators to older adults’ engagement in exercise referral schemes. Social interaction and enjoyment through the group-based programmes are key components to promote adherence and encourage the maintenance of targeted behaviours through peer support and connectedness. Exit strategies and signposting to relevant classes and facilities enabled the maintenance of positive lifestyle behaviours. Conclusions: When designing and implementing interventions, key components enhancing social interaction, enjoyment and continuity should be in place in order to successfully promote sustained behaviour change.

scholarly journals The PACE Study: A randomised clinical trial of cognitive activity (CA) for older adults with mild cognitive impairment (MCI)

Trials ◽  
2009 ◽  
Vol 10 (1) ◽  
Author(s):  
Mandy R Vidovich ◽  
Nicola T Lautenschlager ◽  
Leon Flicker ◽  
Linda Clare ◽  
Osvaldo P Almeida
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Cognitive Activity ◽  
Randomised Clinical Trial

scholarly journals Multidisciplinary Evaluation of Pacifier Removal on Oro-Dentofacial Structures: A Controlled Clinical Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Kelly Guedes de Oliveira Scudine ◽  
Camila Nobre de Freitas ◽  
Kizzy Silva Germano Nascimento de Moraes ◽  
Silvana Bommarito ◽  
Rosana de Fátima Possobon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mixed Model ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Functional Changes ◽  
Mixed Model Anova ◽  
And Function ◽  
Clinical Trials Registry ◽  
Facial Anthropometry ◽  
Over Time

It is well recognized that pacifier habit leads to occlusal and orofacial functional changes in children. However, the effects of the interruption of prolonged pacifier habit on the development of the dento-facial complex has not yet been fully characterized. Thus, the aim of this study was to investigate the influence of pacifier removal on aspects of oro-dentofacial morphology and function in preschool children. For that, a pacifier group (n = 28) and a control group (n = 32) of 4-year-old children with and without pacifier habit, respectively, were followed up by a group of dentists and speech therapists at baseline, 6 and 12 months after habit removal. Bite force and lip pressure were assessed using digital systems, and the evaluation of breathing and speech functions was performed using validated protocols, together with the measurements of dental casts and facial anthropometry. The Two-way mixed model ANOVA was used in data analysis. After 12 months, a decrease in malocclusion frequency was observed in pacifier group. Additionally, a change over time was observed in facial, intermolar and palate depth measurements, as well in bite and lip forces and speech function scores, increasing in both groups (p &lt; 0.01). The upper and lower intercanine widths and breathing scores differed between groups at baseline and changed over time reducing the differences. The presence of speech distortions was more frequent in the pacifier group at baseline and decreased over time (p &lt; 0.05). The interruption of pacifier habit improved the maxillary and mandibular intercanine widths, as well as the breathing and speech functions, overcoming the oro-dentofacial changes found.Trial Registration: This clinical trial was registered in the Brazilian Clinical Trials Registry (ReBEC; http://www.ensaiosclinicos.gov.br/), protocol no. RBR-728MJ2.

scholarly journals Effect of rehabilitation training on an elderly population with mild to moderate hearing loss: study protocol for a randomised clinical trial

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 582
Author(s):  
Parisa Rasouli Fard ◽  
Farnoush Jarollahi ◽  
Seyyed Jalal Sameni ◽  
Mohammad Kamali
Keyword(s):  
Clinical Trial ◽  
Hearing Loss ◽  
Negative Impact ◽  
Intervention Group ◽  
Randomised Clinical Trial ◽  
Control Group ◽  
Rehabilitation Training ◽  
Speech In Noise ◽  
Age Related ◽  
Moderate Hearing Loss

Background: Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-year-olds and has a negative impact on quality of life. The pathophysiology of presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss. Methods: A randomised clinical trial  conduct on 30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease were excluded. Participants were randomly selected to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention Group are 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores are performed at the beginning and end of study to evaluate the effect of rehabilitation training. Conclusion:  Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception restored. Trial registration: Registry of Clinical Trials, IRCT2019625044006N1 (7th August 2019).

Comparing the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in acute Bell's palsy: a pilot randomised clinical trial

2021 ◽  
Vol 28 (3) ◽  
pp. 1-8
Author(s):  
Arnold Fredrick D'Souza ◽  
Sydney Roshan Rebello
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Bell’S Palsy ◽  
Patient Comfort ◽  
Grading System ◽  
Bell's Palsy ◽  
Facial Symmetry ◽  
System P ◽  
And Function ◽  
Facial Clinimetric Evaluation Scale

Background/aims Untreated Bell's palsy may lead to disability and reduced quality of life, while early intervention can improve prognosis. This pilot randomised clinical trial aims to compare the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with acute Bell's palsy. Methods A total of 20 patients diagnosed with Bell's palsy were included in this study after meeting the inclusion criteria. Patients were randomly divided into two groups of ten. Group A received mime therapy while group B received neuromuscular re-education. Each participant received 12 sessions of the respective treatment over 2 weeks and was assessed for facial symmetry and function using the Sunnybrook Facial Grading System and the Facial Clinimetric Evaluation Scale respectively. Results Although both mime therapy and neuromuscular re-education showed highly significant improvements within each group for both the Sunnybrook Facial Grading System (P=0.005) and Facial Clinimetric Evaluation Scale (P=0.005); they showed no difference between each group for the Sunnybrook Facial Grading System (P=0.212) and Facial Clinimetric Evaluation Scale (P=0.97). Conclusions Mime therapy and neuromuscular re-education are equally effective in the recovery of facial symmetry and function in acute Bell's palsy. Physiotherapists can choose between either technique based on their skills and preference or based on patient comfort and expectation.

scholarly journals Electromyogram-Related Neuromuscular Electrical Stimulation for Restoring Wrist and Hand Movement in Poststroke Hemiplegia: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 33 (2) ◽  
pp. 96-111 ◽  
Author(s):  
Katia Monte-Silva ◽  
Daniele Piscitelli ◽  
Nahid Norouzi-Gheidari ◽  
Marc Aureli Pique Batalla ◽  
Philippe Archambault ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Electrical Stimulation ◽  
Meta Analysis ◽  
Neuromuscular Electrical Stimulation ◽  
Structure And Function ◽  
Motor Recovery ◽  
Body Structure ◽  
Short Term ◽  
And Function

Background. Clinical trials have demonstrated some benefits of electromyogram-triggered/controlled neuromuscular electrical stimulation (EMG-NMES) on motor recovery of upper limb (UL) function in patients with stroke. However, EMG-NMES use in clinical practice is limited due to a lack of evidence supporting its effectiveness. Objective. To perform a systematic review and meta-analysis to determine the effects of EMG-NMES on stroke UL recovery based on each of the International Classification of Functioning, Disability, and Health (ICF) domains. Methods. Database searches identified clinical trials comparing the effect of EMG-NMES versus no treatment or another treatment on stroke upper extremity motor recovery. A meta-analysis was done for outcomes at each ICF domain (Body Structure and Function, Activity and Participation) at posttest (short-term) and follow-up periods. Subgroup analyses were conducted based on stroke chronicity (acute/subacute, chronic phases). Sensitivity analysis was done by removing studies rated as poor or fair quality (PEDro score <6). Results. Twenty-six studies (782 patients) met the inclusion criteria. Fifty percent of them were considered to be of high quality. The meta-analysis showed that EMG-NMES has a robust short-term effect on improving UL motor impairment in the Body Structure and Function domain. No evidence was found in favor of EMG-NMES for the Activity and Participation domain. EMG-NMES had a stronger effect for each ICF domain in chronic (≥3 months) compared to acute/subacute phases. Conclusion. EMG-NMES is effective in the short term in improving UL impairment in individuals with chronic stroke.

Impact of spectacles wear on uncorrected visual acuity among urban migrant primary school children in China: a cluster-randomised clinical trial

2020 ◽  
pp. bjophthalmol-2020-316213
Author(s):  
Xinwu Zhang ◽  
Ming Zhou ◽  
Xiaochen Ma ◽  
Hongmei Yi ◽  
Haiqing Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
School Children ◽  
Randomised Clinical Trial ◽  
Primary School Children ◽  
Control Group ◽  
Cluster Randomised ◽  
Uncorrected Visual Acuity ◽  
Chinese School ◽  
Urban Migrant

ObjectiveTo estimate the effect of providing free spectacles on uncorrected visual acuity (VA) among urban migrant Chinese school children.DesignExploratory analysis from a parallel cluster-randomised clinical trial.MethodsAfter baseline survey and VA screening, eligible children were randomised by school to receive one of the two interventions: free glasses and a teacher incentive (tablet computer if ≥80% of children given glasses were wearing them on un-announced examination) (treatment group) or glasses prescription and letter to parents (control group). The primary outcome was uncorrected logarithm of the minimal angle of resolution (LogMAR) VA at study closeout, adjusted for baseline uncorrected VA.ResultsAmong 4376 randomly selected children, 728 (16.6%, mean age 10.9 years, 51.0% boys) at 94 schools failed VA screening and met eligibility criteria. Of these, 358 children (49.2%) at 47 schools were randomised to treatment and 370 children (50.8%) at 47 schools to control. Among these, 679 children (93.3%) completed follow-up and underwent analysis. Spectacle wear in the treatment and control groups was 68.3% and 29.3% (p<0.001), respectively. Uncorrected final VA for eyes of treatment children was significantly better than control children, adjusting only for baseline VA (difference of 0.039 LogMAR units, 95% CI: 0.008, 0.070, equivalent to 0.39 lines, p=0.014) or baseline VA and other baseline factors (0.040 LogMAR units, 95% CI 0.007 to 0.074, equivalent to 0.40 lines, p=0.020).ConclusionWe found no evidence that spectacles wear worsens children’s uncorrected VA among urban migrant Chinese school children.

scholarly journals Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Angel Yañez-Álvarez ◽  
Beatriz Bermúdez-Pulgarín ◽  
Sergio Hernández-Sánchez ◽  
Manuel Albornoz-Cabello
Keyword(s):  
Clinical Trial ◽  
Lower Limb ◽  
Repeated Measures ◽  
Whole Body Vibration ◽  
Patellofemoral Pain ◽  
Whole Body ◽  
Control Group ◽  
Body Vibration ◽  
And Function ◽  
Experimental Group

Abstract Background Patellofemoral pain is a prevalent condition in the general population, especially in women, and produces functional impairment in patients. Therapeutic exercise is considered an essential part of the conservative management. The use of vibration platforms may help improve strength and function and reduce pain in patients with knee disorders. The aim of this investigation was to determine the effects of adding whole body vibration (vertical, vibration frequency of 40 Hz, with an amplitude from 2 to 4 mm) to an exercise protocol for pain and disability in adults with patellofemoral pain. Methods A randomised clinical trial was designed, where 50 subjects were randomly distributed into either an exercise group plus whole body vibration or a control group. Pain, knee function (self-reported questionnaire) and range of motion and lower limb functionality were assessed at baseline and at 4 weeks. The experimental group performed 12 supervised sessions of hip, knee and core strengthening exercises on a vibration platform 3 times per week during 4 weeks. The control group followed the same protocol but without vibration stimuli. Differences in outcome measures were explored using an analysis of the variance of 2 repeated measures. Effect sizes were estimated using Square Eta (η2). Significant level was set al P < 0.05. Results Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η2 = 0.63) and function outcomes scores (P = 0.000; η2 0.39 and 0.51 for lower limb functional scale and Kujala scores respectively). Conclusion A 4-week whole body vibration exercise programme reduces pain level intensity and improves lower limb functionality in patellofemoral pain patients and is more effective than exercise alone in improving pain and function in the short-term. Trial registration ClinicalTrials.gov (NCT04031248). This study was prospectively registered on the 24th July, 2019.

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