Dataset Information

REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia.

ABSTRACT:

Objectives

Congenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12?months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison trial.

Methods and analysis

150 infants (75 in each group), aged between 3 and 6?months ca, with asymmetric brain injury and clinical signs of upper extremity asymmetry will be recruited. Children will be randomised centrally to receive equal doses of either Baby mCIMT or Baby BIM. Baby mCIMT comprises restraint of the unimpaired hand using a simple restraint (eg, glove, sock), combined with intensive parent implemented practice focusing on active use of the impaired hand in a play-based context. In contrast, Baby BIM promotes active play requiring both hands in a play-based context. Both interventions will be delivered by parents at home with monthly home visits and interim telecommunication support by study therapists. Assessments will be conducted at study entry; at 6, 12?months ca immediately postintervention (primary outcome) and 24?months ca (retention). The primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes include the Bayley Scale for Infant and Toddler Development (cognitive and motor domains) and the Hand Assessment of Infants. A subset of children will undertake MRI scans at 24?months ca to evaluate brain lesion severity and brain (re)organisation after intervention.

Ethics and dissemination

Full ethical approvals for this study have been obtained from the relevant sites. The findings will be disseminated in peer-reviewed publications.

Trial registration number

Australian and New Zealand Clinical Trials Registry: ACTRN12615000180516, Pre results.

SUBMITTER: Boyd RN

PROVIDER: S-EPMC5623522 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia.

Boyd Roslyn N RN Ziviani Jenny J Sakzewski Leanne L Novak Iona I Badawi Nadia N Pannek Kerstin K Elliott Catherine C Greaves Susan S Guzzetta Andrea A Whittingham Koa K Valentine Jane J Morgan Cathy C Wallen Margaret M Eliasson Ann-Christin AC Findlay Lisa L Ware Robert R Fiori Simona S Rose Stephen S

BMJ open 20170918 9

<h4>Objectives</h4>Congenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12 months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison ...[more]

PMID: 28928195

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Project description:BackgroundIt is still unclear, which physiotherapeutic approaches are most effective in stroke recovery. Vojta therapy is a type of physiotherapy that was originally developed for children and adolescents with cerebral palsy. Vojta therapy has been reported to improve automatic control of body posture. Because acute stroke patients are characterised by a disturbance in the ability to adapt to changes in body position, requiring automatic postural adjustment, we decided to investigate Vojta therapy in the early rehabilitation of stroke patients. Aim of the trial was to test the hypothesis that Vojta therapy - as a new physiotherapeutic approach in early stroke recovery - improves postural control and motor function in patients with acute ischaemic stroke (AIS) or intracerebral haemorrhage (ICH).MethodsThis prospective, randomised controlled trial included patients with imaging-confirmed AIS or ICH, severe hemiparesis and randomly assigned them to Vojta therapy or standard physiotherapy within 72?h after stroke onset. Main exclusion criterion was restricted ability to communicate. Primary endpoint was the improvement of postural control measured by the Trunk Control Test (TCT) on day 9 after admission. Secondary endpoint among others was improvement of arm function (measured with Motor Evaluation Scale for Upper Extremity in Stroke Patients [MESUPES]).ResultsForty patients (20 per group) were randomised into the trial. Median age was 75 (66-80) years, 50% were women. The median improvement in TCT within 9?days was 25.5 points (=25.5%) (interquartile range [IQR] 12.5-42.5) in the Vojta group and 0 (IQR 0-13) in the control group (p?=?0.001). Patients treated with Vojta therapy achieved a greater improvement in the MESUPES than patients in the control group (20% vs 10%, p?=?0.006).ConclusionThis first randomised controlled trial of Vojta therapy in acute stroke patients demonstrates improvement of postural control through Vojta therapy compared to standard physiotherapy. Although this trial has some methodical weaknesses, Vojta therapy might be a promising approach in early stroke rehabilitation and should be studied in larger trials.Trial registrationClinicalTrials.gov; Unique identifier: NCT03035968. Registered 30 January 2017 - Retrospectively registered; http://www.clinicaltrials.gov.

Project description:BACKGROUND: Congenital hemiplegia is the most common form of cerebral palsy (CP) accounting for 1 in 1300 live births. These children have limitations in capacity to use the impaired upper limb and bimanual coordination deficits which impact on daily activities and participation in home, school and community life. There are currently two diverse intensive therapy approaches. Traditional therapy has adopted a bimanual approach (BIM training) and recently, constraint induced movement therapy (CIMT) has emerged as a promising unimanual approach. Uncertainty remains about the efficacy of these interventions and characteristics of best responders. This study aims to compare the efficacy of CIMT to BIM training to improve outcomes across the ICF for school children with congenital hemiplegia. METHODS/DESIGN: A matched pairs randomised comparison design will be used with children matched by age, gender, side of hemiplegia and level of upper limb function. Based on power calculations a sample size of 52 children (26 matched pairs) will be recruited. Children will be randomised within pairs to receive either CIMT or BIM training. Both interventions will use an intensive activity based day camp model, with groups receiving the same dosage of intervention delivered in the same environment (total 60 hours over 10 days). A novel circus theme will be used to enhance motivation. Groups will be compared at baseline, then at 3, 26 and 52 weeks following intervention. Severity of congenital hemiplegia will be classified according to brain structure (MRI and white matter fibre tracking), cortical excitability using Transcranial Magnetic Stimulation (TMS), functional use of the hand in everyday tasks (Manual Ability Classification System) and Gross Motor Function Classification System (GMFCS). Outcomes will address neurovascular changes (functional MRI, functional connectivity), and brain (re)organisation (TMS), body structure and function (range of motion, spasticity, strength and sensation), activity limitations (upper limb unimanual capacity and bimanual motor coordination), participation restrictions (in home, school and recreation), environmental (barriers and facilitators to participation) and quality of life. DISCUSSION: This paper outlines the theoretical basis, study hypotheses and outcome measures for a matched pairs randomised trial comparing CIMT and BIM training to improve outcomes across the ICF. TRIAL REGISTRATION: ACTRN12609000912280.

Project description:INTRODUCTION:Intermittent theta burst stimulation (iTBS) applied to primary motor cortex (M1) has been shown to modulate both the excitability and connectivity of the motor system. A recent proof-of-principle study, based on a small group of hospitalised patients with acute ischemic stroke, suggested that iTBS applied to the ipsilesional M1 combined with physical therapy early after stroke can amplify motor recovery with lasting after effects. A randomised controlled clinical trial using a double-blind design is warranted to justify the implementation of iTBS-assisted motor rehabilitation in neurorehabilitation from an acute ischaemic stroke. METHODS/DESIGN:We investigate the effects of daily iTBS on early motor rehabilitation after stroke in an investigator-initiated, longitudinal randomised controlled trial. Patients (n=150) with hemiparesis receive either iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45°). On 8 consecutive workdays, a 45 min arm-centred motor training follows the intervention . The relative grip strength, defined as the grip force ratios of the affected and unaffected hands, serves as the primary outcome parameter. Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1. ETHICS AND DISSEMINATION:The study was approved by the Ethics Commission of the Medical Faculty, University of Cologne, Germany (reference number 15-343). Data will be disseminated through peer-reviewed publications and presentations at conferences. Study title: Theta-Burst Stimulation in Early Rehabilitation after Stroke (acronym: TheSiReS). Study registration at German Registry for Clinical Trials (DRKS00008963) and at ClinicalTrials.gov (NCT02910024).

Project description:BACKGROUND:Mobility limitations among older adults increase the risk for disability and healthcare utilization. Rehabilitative care is identified as the most efficacious treatment for maintaining physical function. However, there is insufficient evidence identifying a healthcare model that targets prevention of mobility decline among older adults. The objective of this study is to evaluate the preliminary effectiveness of a physical therapy program, augmented with mobile tele-health technology, on mobility function and healthcare utilization among older adults. METHODS:This is a quasi-experimental 12-month clinical trial conducted within a metropolitan-based healthcare system in the northeastern United States. It is in parallel with an existing longitudinal cohort study evaluating mobility decline among community-dwelling older adult primary care patients over one year. Seventy-five older adults (? 65-95 years) are being recruited using identical inclusion/exclusion criteria to the cohort study. Three aims will be evaluated: the effect of our program on 1) physical function, 2) healthcare utilization, and 3) healthcare costs. Changes in patient-reported function over 1 year in those receiving the intervention (aim 1) will be compared to propensity score matched controls (N = 150) from the cohort study. For aims 2 and 3, propensity scores, derived from logistic regression model that includes demographic and diagnostic information available through claims and enrollment information, will be used to match treatment and control patients in a ratio of 1:2 or 1:3 from a Medicare Claims Registry derived from the same geographic region. The intervention consists of a one-year physical therapy program that is divided between a combination of outpatient and home visits (6-10 total visits) and is augmented on a computerized tablet using of a commercially available application to deliver a progressive home-based exercise program emphasizing lower-extremity function and a walking program. DISCUSSION:Incorporating mobile health into current healthcare models of rehabilitative care has the potential to decrease hospital visits and provide a longer duration of care. If the hypotheses are supported and demonstrate improved mobility and reduced healthcare utilization, this innovative care model would be applicable for optimizing the maintenance of functional independence among community-dwelling older adults. TRIAL REGISTRATION:ClinicalTrial.gov Identifier: NCT02580409 (Date of registration October 14, 2015).

Project description:IntroductionChildren with congenital hemiplegia often present with limitations in using their impaired upper limb which impacts on independence in activities of daily living, societal participation and quality of life. Traditional therapy has adopted a bimanual training approach (BIM) and more recently, modified constraint induced movement therapy (mCIMT) has emerged as a promising unimanual approach. Evidence of enhanced neuroplasticity following mCIMT suggests that the sequential application of mCIMT followed by bimanual training may optimise outcomes (Hybrid CIMT). It remains unclear whether more intensely delivered group based interventions (hCIMT) are superior to distributed models of individualised therapy. This study aims to determine the optimal density of upper limb training for children with congenital hemiplegia.Methods and analysesA total of 50 children (25 in each group) with congenital hemiplegia will be recruited to participate in this randomized comparison trial. Children will be matched in pairs at baseline and randomly allocated to receive an intensive block group hybrid model of combined mCIMT followed by intensive bimanual training delivered in a day camp model (COMBiT; total dose 45 hours direct, 10 hours of indirect therapy), or a distributed model of standard occupational therapy and physiotherapy care (SC) over 12 weeks (total 45 hours direct and indirect therapy). Outcomes will be assessed at 13 weeks after commencement, and retention of effects tested at 26 weeks. The primary outcomes will be bimanual coordination and unimanual upper-limb capacity. Secondary outcomes will be participation and quality of life. Advanced brain imaging will assess neurovascular changes in response to treatment. Analysis will follow standard principles for RCTs, using two-group comparisons on all participants on an intention-to-treat basis. Comparisons will be between treatment groups using generalized linear models.Trial registrationACTRN12613000181707.

Project description:INTRODUCTION:Acupuncture is safe and effective for improving the motor function of poststroke hemiplegic patients, but there still exists a certain gap between clinical practice and understanding its neural mechanisms. The cerebral functional reconstruction after unilateral motor pathway injury exhibits a bilateral tendency, however current studies seldom pay attention to it. Hence, based on cerebral bilateral connections, the underlying mechanism of acupuncture in stroke rehabilitation remains an area for further research. The results of this study will increase our understanding of acupuncture-induced motor recovery in patients who had suffered a stroke and demonstrate the differences in brain response and clinical assessments. METHODS AND ANALYSIS:This is a single-centre, randomised controlled, paralleled neuroimaging trial, with patients and outcome assessors blinded. Thirty patients who had a stroke with motor dysfunction meeting the inclusion criteria will be randomly assigned (2:1) to receive either 10 sessions true or sham acupoints treatments (five sessions per week for 2 weeks). All the participants will receive conventional standard medical care and rehabilitation. Motor function assessments and neuroimaging scanning will be conducted before and after the entire acupuncture treatment. The clinical and neuroimaging data will be analysed, respectively. The voxel-mirrored homotopic connectivity will be the primary outcome and the primary effect indicator. The secondary outcomes comprise clinical evaluations and neuroimaging assessments, which include Fugl-Meyer Assessment, the National Institutes of Health Stroke Scale, fractional anisotropy and gray matter volume. The Needle Sensation Assessment Scale is an additional outcome. The correlation analysis will be explored between the neuroimaging indicators, clinical motor assessments and needle sensation. ETHICS AND DISSEMINATION:The protocol has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2018-04). The results of the neuroimaging trial will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER:Chinese Clinical Trials Registry (ChiCTR 1800016263).

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Project description:INTRODUCTION:Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. METHODS/ANALYSIS:SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4?weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted. ETHICS AND DISSEMINATION:SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and negative results of the trial will be submitted to international peer-reviewed journals. Furthermore, results will be presented at national and international conferences relevant to the subject fields. TRIAL REGISTRATION NUMBER:NCT02290262; pre-results.

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Dataset Information

REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia.

Objectives

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia.

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