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Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease.

ABSTRACT: Postural instability is a particularly incapacitating disorder, whose loss of motor independence by Parkinson´s Disease (PD) patients marks a significant stage of disease onset. Evidence suggests that deficits in automatic motor control, sensory integration and attention are associated with the lack of balance in PD. Physiotherapy together with medication play an important role in the treatment of this state, although no consensus has been reached on the best treatment modality. The aim of this randomized controlled trial protocol is to evaluate the effects of balance training with rhythmical (BRT), which is a motor program to improve balance associated with rhythmical auditory cues (RACs). This study is ongoing in the stage 1.A total of 150 PD patients at H&Y stages II-III and asymptomatic for depression and dementia are enrolled in a single-blind randomized study. Randomization is achieved via a computer-generated random-sequence table. All patients should also present a fall history. They will be assigned into one of three groups, and their balance and gait will be assessed before and after 10 training sessions, and after 4 and 30 weeks subsequent to the end of the training. The BRT group will receive a motor program to improve balance associated with RACs, the MT group will perform motor training with the same aims as those in the BRT group but without RACs, and the control group (CG) will be trained only in orientations. The exercise program specific to balance is of 5 weeks' duration with two sessions per week, 45 min each, and consists of general physiotherapy exercises. Each session will be divided into five warm-up minutes-30 min for the main part and 10 min for the cool down. The training progresses and intensifies each week depending on the individual's performance. The subjects should be able to execute 10 repetitions of the exercise sequences correctly to progress to the next movement.This randomized study protocol will evaluate the effects of a motor program designed to improve balance associated with RACs, and will also assess whether balance training leads to activation of balance reactions at the appropriate time. We hypothesize that if this motor program is maintained long-term, it will prevent falls.Clinicaltrials.gov NCT02488265 ; Ethics Committee of the University of São Paulo Faculty of Medicine Clinics Hospital 1.102.464.

SUBMITTER: Capato TT

PROVIDER: S-EPMC4561447 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease.

Capato Tamine Teixeira da Costa TT Tornai Juliana J Ávila Patrícia P Barbosa Egberto Reis ER Piemonte Maria Elisa Pimentel ME

BMC neurology 20150907

<h4>Background</h4>Postural instability is a particularly incapacitating disorder, whose loss of motor independence by Parkinson´s Disease (PD) patients marks a significant stage of disease onset. Evidence suggests that deficits in automatic motor control, sensory integration and attention are associated with the lack of balance in PD. Physiotherapy together with medication play an important role in the treatment of this state, although no consensus has been reached on the best treatment modalit ...[more]

PMID: 26347052

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Project description:BackgroundBalance impairment in Parkinson's disease (PD) improves only partially with dopaminergic medication. Therefore, non-pharmacological interventions such as physiotherapy are important elements in clinical management. External cues are often applied to improve gait, but their effects on balance control are unclear.Objective/methodsWe performed a prospective, single-blind, randomized clinical trial to study the effectiveness of balance training with and without rhythmical auditory cues. We screened 201 volunteers by telephone; 154 were assigned randomly into three groups: (1) multimodal balance training supported by rhythmical auditory stimuli (n = 56) (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmical auditory stimuli (n = 50); and (3) control intervention involving a general education program (n = 48). Training was performed for 5 weeks, two times/week. Linear mixed models were used for all outcomes. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by a single, blinded assessor at baseline, immediately post intervention, and after one and 6-months follow-up.ResultsImmediately post intervention, RAS-supported multimodal balance training was more effective than regular multimodal balance training on MBEST (difference 3.5 (95% Confidence Interval (CI) 2.2; 4.8)), p < 0.001). Patients allocated to both active interventions improved compared to controls (MBEST estimated mean difference versus controls 6.6 (CI 5.2; 8.0), p < 0.001 for RAS-supported multimodal balance training; and 3.0 (CI 2.7; 5.3), p < 0.001 for regular multimodal balance training). Improvements were retained at one-month follow-up for both active interventions, but only the RAS-supported multimodal balance training group maintained its improvement at 6 months.ConclusionBoth RAS-supported multimodal balance training and regular multimodal balance training improve balance, but RAS-supported multimodal balance training-adding rhythmical auditory cues to regular multimodal balance training-has greater and more sustained effects.

Project description:BackgroundReduced muscle strength is an independent risk factor for falls and related to postural instability in individuals with Parkinson's disease. The ability of resistance training to improve postural control still remains unclear.ObjectiveTo compare resistance training with balance training to improve postural control in people with Parkinson's disease.Methods40 patients with idiopathic Parkinson's disease (Hoehn&Yahr: 2.5-3.0) were randomly assigned into resistance or balance training (2x/week for 7 weeks). Assessments were performed at baseline, 8- and 12-weeks follow-up: primary outcome: Fullerton Advanced Balance (FAB) scale; secondary outcomes: center of mass analysis during surface perturbations, Timed-up-and-go-test, Unified Parkinson's Disease Rating Scale, Clinical Global Impression, gait analysis, maximal isometric leg strength, PDQ-39, Beck Depression Inventory. Clinical tests were videotaped and analysed by a second rater, blind to group allocation and assessment time.Results32 participants (resistance training: n = 17, balance training: n = 15; 8 drop-outs) were analyzed at 8-weeks follow-up. No significant difference was found in the FAB scale when comparing the effects of the two training types (p = 0.14; effect size (Cohen's d) = -0.59). Participants from the resistance training group, but not from the balance training group significantly improved on the FAB scale (resistance training: +2.4 points, Cohen's d = -0.46; balance training: +0.3 points, Cohen's d = -0.08). Within the resistance training group, improvements of the FAB scale were significantly correlated with improvements of rate of force development and stride time variability. No significant differences were found in the secondary outcome measures when comparing the training effects of both training types.ConclusionsThe difference between resistance and balance training to improve postural control in people with Parkinson's disease was small and not significant with this sample size. There was weak evidence that freely coordinated resistance training might be more effective than balance training. Our results indicate a relationship between the enhancement of rate of force development and the improvement of postural control.Trial registrationClinicalTrials.gov ID: NCT02253563.

Project description:BackgroundFalls are a common cause of injuries and hospitalization among older adults. While conventional balance training appears effective in preventing falls, a relatively large number of training sessions are needed and retention of the effects after the training period is hard to accomplish. This may be because these interventions are not sufficiently task-specific for the mechanism of falls. Many falls in older adults occur due to unexpected external perturbations during gait, such as trips. Therefore, there is increasing interest in perturbation-based balance training (PBT), which is a more task-specific intervention to improve reactive balance control after unexpected perturbations. The literature suggests that PBT may be more effective and require fewer training sessions to reduce falls incidence in older adults, than conventional balance training. We aim to evaluate the effect of a three-session PBT protocol on balance control, daily life falls and fear of falling. Secondly, we will evaluate the acceptability of the PBT protocol.MethodsThis is a mixed-methods study combining a single-blind (outcome assessor) randomized controlled trial (RCT) using a parallel-group design, and qualitative research evaluating the acceptability of the intervention. The study sample consists of community-dwelling older adults aged 65 years and older who have recently fallen and visited the MUMC+ outpatient clinic. Subjects are randomized into two groups. The control group (n = 40) receives usual care, meaning referral to a physical therapist. The intervention group (n = 40) receives usual care plus three 30-min sessions of PBT in the Computer Assisted Rehabilitation Environment. Subjects' balance control (Mini-BESTest) and fear of falling (FES-I) will be assessed at baseline, and 4 weeks and 3 months post-baseline. Daily life falls will be recorded with falls calendars until 6 months after the first follow-up measurement, long-term injurious falls will be recorded at 2-years' follow-up via the electronic patient record. Acceptability of the PBT protocol will be evaluated with semi-structured interviews in a subsample from the intervention group.DiscussionThis study will contribute to the evidence for the effectiveness of PBT using a training protocol based on the available literature, and also give much needed insights into the acceptability of PBT for older adults.Trial registrationNederlands Trial Register NL7680 . Registered 17-04-2019 - retrospectively registered.

Project description:IntroductionBalance disturbances in Parkinson's Disease (PD) are usually assessed in a single-task as well as standard balance physiotherapy is carried out in isolated environments. Conversely, daily activities are developed in highly challenging environments. Although functional balance training (FBT) is included in the latest protocols, several methodological issues have not yet been considered. In the proposed single-blinded randomized control trial with crossover (NCT04963894), the aims are (1) to quantify the effects achieved by domiciliary FBT (balanceHOME program) in participants with and without cognitive impairment, and (2) to compare them with the effects of a passive-control period and a conventional face-to-face physiotherapy program for PD.MethodsThe initial recruitment was estimated at 112 people with idiopathic PD. Two-thirds of the participants will be randomized to one of the two groups to make the crossover. In contrast, the other third will do a face-to-face group program only. The balanceHOME protocol consists of challenging balance exercises incorporated into functional daily tasks, developed in-home and conducted two times per week for 60-min over an 8-weeks period. The primary strategy will consist of splitting functional tasks of daily life into static and dynamic balance components, besides standardized facilitate and disturbing strategies to execution of each exercise. Biomechanics and clinical performance of balance and gait, perception of quality of life, cognitive and mental functioning, and severity of PD will be measured at baseline (T0), post-8 weeks training (T1), and follow-up (T2).ResultsThe primary outcome of the study will be the center of pressure sway area. The secondary outcomes consist of biomechanics and clinical variables related to static and dynamic balance. Outcomes from biomechanical of gait, quality of life, cognitive and mental state, and severity of PD, represent the tertiary outcomes.DiscussionThe balanceHOME program standardizes the FBT in demanding and daily environments for people with PD who prefer individualized treatment from home. This is the first time that the effects of group versus individual balance rehabilitation have been compared in people with and without cognitive impairment and evaluated in complex environments. This still-to-be-finished study will open the possibility of new strategies according to changes in post-pandemic therapeutic approaches.

Project description:BackgroundPeople with Parkinson's disease (PD) commonly experience postural instability, resulting in poor balance and an increased risk of falls. Exercise-based video gaming (exergaming) is a form of physical training that is delivered through virtual reality technology to facilitate motor learning and is efficacious in improving balance in aged populations. In addition, studies have shown that anodal transcranial direct current stimulation (a-tDCS), when applied to the primary motor cortex, can augment motor learning when combined with physical training. However, no studies have investigated the combined effects of exergaming and tDCS on balance in people with PD.Methods/designTwenty-four people with mild to moderate PD (Hoehn and Yahr scale score 2-4) will be randomly allocated to receive one of three interventions: (1) exergaming + a-tDCS, (2) exergaming + sham a-tDCS or (3) usual care. Participants in each exergaming group will perform two training sessions per week for 12 weeks. Each exergaming session will consist of a series of static and dynamic balance exercises using a rehabilitation-specific software programme (Jintronix) and 20 minutes of either sham or real a-tDCS (2 mA) delivered concurrently. Participants allocated to usual care will be asked to maintain their normal daily physical activities. All outcome measures will be assessed at baseline and at 6 weeks (mid-intervention), 12 weeks (post-intervention) and 24 weeks (3-month follow-up) after baseline. The primary outcome measure will be the Limits of Stability Test. Secondary outcomes will include measures of static balance, leg strength, functional capacity, cognitive task-related cortical activation, corticospinal excitability and inhibition, and cognitive inhibition.DiscussionThis will be the first trial to target balance in people with PD with combined exergaming and a-tDCS. We hypothesise that improvements in balance, functional and neurophysiological outcome measures, and neurocognitive outcome measures will be greater and longer-lasting following concurrent exergaming and a-tDCS than in those receiving sham tDCS or usual care.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616000594426 ). Registered on 9 May 2016.

Project description:IntroductionDance is an intrinsically motivating activity that includes social interaction, stimulation through music, the pleasure of moving despite pathology-induced motor limitations, and it also has good perceived benefits among participants. Feeling pleasure while moving is essential to finding the motivation to engage in a rehabilitation programme. It is, therefore, urgent to provide persons in a poststroke situation with motivating physical activity opportunities. Very few studies have examined dance in a stroke context, while it is highly adapted and effective for other chronic conditions.Our primary objective is to assess the effects of dance programme on patients' balance control after stroke. Our secondary objective is to investigate the effects of dance on cognitive function, strength, coordination, functional status, balance confidence, quality of life, motivation and adherence. Our hypothesis is that dance increases balance and motor capacities, and improves poststroke quality of life, adherence and motivation.Methods and analysisForty-eight subjects with stroke in subacute phase will be randomised into two groups: (1) intervention (dance and standard rehabilitation) and (2) control (standard rehabilitation). Before intervention, stroke severity, cognitive abilities and motor capacities will be assessed. Two baseline tests will be planned to evaluate the stability of individuals. Participants will attend a weekly 60-min dance class for 6 weeks. Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups. Participant satisfaction with regard to dance will be tested, as well as adherence and adverse effects.Ethics and disseminationEthics approval has been granted by the Swiss Ethics Committee of the CER Vaud (2019-01467). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at conferences.Trial registration numberNCT04120467.

Project description:BackgroundGait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors.MethodsA parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety.ResultsBetween November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study.ConclusionWe believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown.Trial registrationISRCTN, ISRCTN10874601 , Registered on 05/03/2018.

Project description:Introduction: Patients with Parkinson's disease (PD) often exhibit difficulties with dexterity during the performance of activities of daily living (ADL) due to dysfunctional supplementary motor area (SMA). The aim of this clinical trial protocol work is to describe how the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) over SMA and video-game-based skill training (VBT) in PD will be evaluated. The short and long-term benefits are assessed. Methods and analysis: A single-blind (patients) stratified (based on Hoehn & Yahr) parallel randomized sham-controlled rTMS-VBT study with a baseline and two follow-up measurements (3 and 12 weeks) is being conducted. These measurements include the dexterity questionnaire 24 (DextQ-24) as a primary outcome, and nine hole peg test and coin rotation task as main secondary dexterity outcomes. Further secondary outcomes will be the subscale II of the movement disorders society unified PD rating scale (MDS-UPDRS) to assess improvements on overall ADL and the Parkinson's Disease Questionnaire-39 to assess quality of life. Thirty-six outpatients (from one neurorehabilitation center) with PD (diagnosis based on brain bank criteria) will be recruited who report difficulties with dexterity in performing ADL. All PD patients will receive a 45-min VBT three times a week for 3 weeks. The PD patients randomized in the experimental group will receive VBT preceded by real rTMS, being intermittent theta burst (iTBS) stimulation sessions. The PD patients randomized to the control group receive a VBT with sham rTMS. Discussion: The study will provide evidence to determine whether a combined iTBS and VBT skill intervention is more effective than a VBT intervention alone to improve dexterity in PD. Ethics and dissemination: The study was approved by the Ethics Committee for Northwest and Central Switzerland (EKNZ), Switzerland 2019-00433. The study will be conducted in accordance with the Helsinki Declaration and the Guidelines of Good Clinical Practice. Informed consent will be signed prior to subject enrolment. Dissemination will include submission to international peer-reviewed professional journals and presentation at international congresses. The study protocol has been registered in the clinicaltrials.gov registry with the identification code: NCT04699149.

Project description:BackgroundFalls are more prevalent in stroke survivors than age-matched healthy older adults because of their functional impairment. Rapid balance recovery reaction with adequate range-of-motion and fast response and movement time are crucial to minimize fall risk and prevent serious injurious falls when postural disturbances occur. A Kinect-based Rapid Movement Training (RMT) program was developed to provide real-time feedback to promote faster and larger arm reaching and leg stepping distances toward targets in 22 different directions.ObjectiveTo evaluate the effectiveness of the interactive RMT and Conventional Balance Training (CBT) on chronic stroke survivors' overall balance and balance recovery reaction.MethodsIn this assessor-blinded randomized controlled trial, chronic stroke survivors were randomized to receive twenty training sessions (60-min each) of either RMT or CBT. Pre- and post-training assessments included clinical tests, as well as kinematic measurements and electromyography during simulated forward fall through a "lean-and-release" perturbation system.ResultsThirty participants were recruited (RMT = 16, CBT = 14). RMT led to significant improvement in balance control (Berg Balance Scale: pre = 49.13, post = 52.75; P = .001), gait control (Timed-Up-and-Go Test: pre = 14.66 s, post = 12.62 s; P = .011), and motor functions (Fugl-Meyer Assessment of Motor Recovery: pre = 60.63, post = 65.19; P = .015), which matched the effectiveness of CBT. Both groups preferred to use their non-paretic leg to take the initial step to restore stability, and their stepping leg's rectus femoris reacted significantly faster post-training (P = .036).ConclusionThe RMT was as effective as conventional balance training to provide beneficial effects on chronic stroke survivors' overall balance, motor function and improving balance recovery with faster muscle response.Trial registrationThe study was registered at Clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT03183635 , NCT03183635) on 12 June 2017.

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Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease.

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Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease.

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