scholarly journals Contextual interference in children with brain lesions: a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Judith V. Graser ◽  
Caroline H. G. Bastiaenen ◽  
Anja Gut ◽  
Urs Keller ◽  
Hubertus J. A. van Hedel
Keyword(s):  
Pilot Study ◽  
Upper Limb ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Random Order ◽  
Recruitment Rate ◽  
Brain Lesions ◽  
Contextual Interference ◽  
Exclusion Criteria ◽  
Randomised Controlled

Abstract Introduction Evidence about contextual interference in children with brain lesions when practising motor tasks is lacking. Our main objective was to evaluate the feasibility of a randomised controlled trial (RCT) comparing blocked with random practice order of an upper limb robotic exergame to improve reaching in children with neuromotor disorders with a pilot trial. Methods We recruited children with brain lesions and impaired upper limb functions who underwent a 3-week schedule that consisted of baseline assessments, intervention period (participants were randomised to a blocked or random order group), and follow-up assessment. We evaluated ten feasibility criteria, including the practicability of the inclusion/exclusion criteria, recruitment rate, feasibility of randomisation, scheduling procedure, and the participants’ programme adherence. Results The inclusion/exclusion criteria were not completely feasible as patients who were not able to perform the exergames were included. Twelve participants were recruited, and six datasets were used for analysis. The scheduling and randomisation procedures were generally feasible, but the procedure was only partially feasible for the participants, as some sessions were aborted due to lack of motivation and fatigue. Conclusion An RCT following this study protocol is not feasible. We formulated suggestions for future studies that aim to investigate contextual interference as in this pilot study. Trial registration ClinicalTrials.gov Identifier: NCT02443857, registered on May 14, 2015

scholarly journals Contextual interference in children with brain lesions: protocol of a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Judith V. Graser ◽  
Caroline H. G. Bastiaenen ◽  
Urs Keller ◽  
Hubertus J. A. van Hedel
Keyword(s):  
Pilot Study ◽  
Upper Limb ◽  
Brain Lesions ◽  
Contextual Interference ◽  
Power Calculation ◽  
Robot Assisted ◽  
Main Trial ◽  
Reaching Tasks ◽  
Transfer And Retention ◽  
Randomised Controlled

Abstract Background If adults practice several motor tasks together, random practice leads to better transfer and retention compared to blocked practice. Knowledge about this contextual interference (CI) effect could be valuable to improve neurorehabilitation of children. We present the protocol of a randomised controlled pilot study investigating the feasibility of blocked practice vs. random practice of robot-assisted upper limb reaching in children with brain lesions undergoing neurorehabilitation. Methods Children with affected upper limb function due to congenital or acquired brain lesions undergoing neurorehabilitation will be recruited for a randomised controlled pilot study with a 3-week procedure. In the control week (1), two assessment blocks (robot-assisted reaching tasks, Melbourne assessment 2, subscale fluency), 2 days apart, take place. In the practice week (2), participants are randomly allocated to blocked practice or random practice and perform 480 reaching and backward movements in the horizontal and vertical plane using exergaming with an exoskeleton robot per day during three consecutive days. Assessments are performed before, directly after and 1 day after the practice sessions. In the follow-up week (3), participants perform the assessments 1 week after the final practice session. The primary outcome is the immediate transfer of the Melbourne Assessment 2, subscale fluency. Secondary outcomes are the immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions. We will evaluate the feasibility of the inclusion criteria, the recruitment rate, the scheduling procedure, the randomisation procedure, the procedure for the participants, the handling of the robot, the handling of the amount of data, the choice of the outcome measures and the influence of other therapies. Furthermore, we will perform a power calculation using the data to estimate the sample size for the main trial. Discussion The protocol of the pilot study is a first step towards a future main randomised controlled trial. This low risk pilot study might induce some benefits for the participants. However, we need to place its results into perspective, especially concerning the generalisability, as it remains questionable whether improving reaching constrained within a robotic device will ameliorate daily life reaching tasks. Trial registration ClinicalTrials.gov Identifier: NCT02443857

scholarly journals The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial.

2021 ◽  
Author(s):  
Parvati Rose Perman-Howe ◽  
Emma L Davies ◽  
David R Foxcroft
Keyword(s):  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Sample Size ◽  
Study Protocol ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Participant Recruitment ◽  
Licensed Premises ◽  
Randomised Controlled

Abstract Background Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. Aims: (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK), (2) provide data to estimate key parameters for a RCT. Methods Double-blind randomised controlled cross-over pilot trial based within four licensed premises in the UK. Participants (n=36) purchased and consumed ad libitum a 3.5% lager and a 4.8% lager during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed.Results Components of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated. The participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): -3.76 (-5.01 to -2.52).The sample size required for a RCT is 53. Participants did not find one lager more pleasant in taste: (on a scale of one to 10) -0.95 (-2.11 to 0.21). Participants found the reduced-strength lager less enjoyable: (on a scale of one to 10) -1.44 (-2.64 to -0.24) and they perceived themselves to be less intoxicated after consuming it: (on a scale of one to 10) -1.00 (-1.61 to -0.40).Conclusion A RCT is feasible with minor alterations to the study protocol and scoping work to establish different brands of alcohol that are more alike and more enjoyable than the products used in the pilot trial. Trial registration Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017: https://www.socialscienceregistry.org/trials/2266. Unique identifying number: AEARCTR-0002266.

scholarly journals Accessibility of Apple iPad for partially sighted users: pilot study

2014 ◽  
Vol 8 (1) ◽  
pp. 2-13 ◽  
Author(s):  
Rachel Hewett ◽  
Carole Torgerson ◽  
Graeme Douglas
Keyword(s):  
Pilot Study ◽  
Low Vision ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Tablet Computer ◽  
Content Type ◽  
Significance Level ◽  
Apple Ipad ◽  
Randomised Controlled ◽  
Partially Sighted

Purpose – The purpose of this paper is to present the results of a pilot trial, investigating the accessibility provided by a tablet computer (Apple iPad) to individuals with visual impairment. The study was designed around an N-of-1 randomised controlled trial (RCT), which was replicated for 12 participants. It served as an opportunity to evaluate the use N-of-1 trials in studies involving people who are visually impaired. Design/methodology/approach – The study centred round an N-of-1 RCT, comparing the accessibility provided by control equipment (Windows computer) against the intervention equipment (Apple iPad). Twelve participants conducted six tests on the equipment as per randomisation, followed by a quantitative-based evaluation and short interviews. Findings – One-sided individual randomisation tests showed a significant result for overall satisfaction in favour of the tablet at the 0.05 significance level for seven of the participants. Participants identified several strengths of the iPad in helping a partially sighted user in accessing the internet: inbuilt zoom and magnification options; increased control as a result of the touch screen; and accessibility tools being built into the operating system. The main limitation suggested was the way the zoom function operates by enlarging the onscreen keyboard. This caused difficulties for those with more severe visual impairments using this function in inputting text. Originality/value – There has been limited research to substantiate positive reviews of the tablet computer for low-vision users. The results of this pilot study gives evidence in support of these potential benefits, and demonstrates the importance of a more thorough investigation.

scholarly journals The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Parvati R. Perman-Howe ◽  
Emma L. Davies ◽  
David R. Foxcroft
Keyword(s):  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Sample Size ◽  
Study Protocol ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Participant Recruitment ◽  
Licensed Premises ◽  
Randomised Controlled

Abstract Background Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. The aims of this study are to (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK), and to (2) provide data to estimate key parameters for a RCT. Methods This study is a double-blind randomised controlled cross-over pilot trial based within four licensed premises in the UK. Participants (n = 36) purchased and consumed ad libitum a 3.5% lager and a 4.8% lager during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed. Results Components of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated. The participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): − 3.76 (− 5.01 to − 2.52). The sample size required for a RCT is 53. Participants did not find one lager more pleasant in taste: (on a scale of one to 10) − 0.95 (− 2.11 to 0.21). Participants found the reduced-strength lager less enjoyable: (on a scale of one to 10) − 1.44 (− 2.64 to − 0.24) and they perceived themselves to be less intoxicated after consuming it: (on a scale of one to 10) − 1.00 (− 1.61 to − 0.40). Conclusion A RCT is feasible with minor alterations to the study protocol and scoping work to establish different brands of alcohol that are more alike and more enjoyable than the products used in the pilot trial. Trial registration Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017. Unique identifying number: AEARCTR-0002266.

scholarly journals SaeboGlove therapy for upper limb disability and severe hand impairment after stroke (SUSHI): Study protocol for a randomised controlled trial

2021 ◽  
pp. 239698732110365
Author(s):  
Jen Alexander ◽  
Peter Langhorne ◽  
Lisa Kidd ◽  
Olivia Wu ◽  
Alex McConnachie ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Upper Limb ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Economic Evaluations ◽  
Limb Function ◽  
Upper Limb Function ◽  
Randomised Controlled ◽  
Hand Impairment

Background Impaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery. The SaeboGlove assists digital extension and may improve outcome after stroke. We recently performed a single group, open, pilot trial of the SaeboGlove early after stroke which demonstrated satisfactory safety, feasibility and acceptability. An adequately powered randomised clinical trial is now needed to assess the clinical effectiveness of the SaeboGlove. Methods SUSHI is a pragmatic, multicentre, parallel-group, randomised controlled trial with blinded outcome assessment, and embedded process and economic evaluations. Adults, 7–60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland. Participants will be randomised on a 1:1 basis to receive 6 weeks of self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only. The primary outcome is upper limb function measured by the Action Research Arm Test (ARAT) at 6 weeks. Secondary outcomes will be measured at 6 and 14 weeks. A process evaluation will be performed via interviews with ‘intervention’ participants, and their carers and clinical therapists. A within-trial cost-effectiveness analysis will be performed. 110 participants are required to detect a difference between groups of 9 in the ARAT with 90% power at a 5% significance level allowing for 11% attrition. Discussion SUSHI will determine if SaeboGlove self-directed, repetitive, functional-based practice improves upper limb function after stroke, whether it is acceptable to stroke survivors and whether it is cost-effective.

scholarly journals The Effect of Alcohol Strength on Alcohol Consumption: Findings from A Randomised Controlled Cross-Over Pilot Trial.

2020 ◽  
Author(s):  
Parvati Rose Perman-Howe ◽  
Emma L Davies ◽  
David R Foxcroft
Keyword(s):  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Sample Size ◽  
Study Protocol ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Participant Recruitment ◽  
Licensed Premises ◽  
Randomised Controlled

Abstract Background Reducing the alcohol content of drinks has the potential to reduce population level alcohol consumption. This pilot study aimed to (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK); and (2) provide data to estimate key parameters for a RCT. MethodsA double-blind randomised controlled cross-over pilot trial was based within four licensed premises in the UK. Participants (n=36) purchased and consumed ad libitum a 3.5% lager (intervention), and a taste matched 4.8% lager (control) during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between study conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed.ResultsComponents of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated whilst the participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): -3.76 (-5.01 to -2.52). Based on a conservative estimate, using the smallest effect size in the CI (-2.52) and allowing for 23% attrition, the sample size required for a RCT powered at 95% is 53. Participants did not find one lager notably more pleasant in taste than the other: (on a scale of one to 10) -0.95 (-2.11 to 0.21). However, participants found the reduced-strength lager notably less enjoyable than the regular-strength lager: (on a scale of one to 10) -1.44 (-2.64 to -0.24) and they perceived themselves to be notably less intoxicated after consuming the reduced-strength lager: (on a scale of one to 10) -1.00 (-1.61 to -0.40).ConclusionA RCT is feasible with minor alterations to the study protocol and prior scoping work to establish different brands of alcohol that are more alike and more enjoyable than the intervention and control products used in the pilot trial. Trial registrationThe trial is registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017: https://www.socialscienceregistry.org/trials/2266. The unique identifying number is: AEARCTR-0002266.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048178
Author(s):  
Katie Mellor ◽  
Saskia Eddy ◽  
Nicholas Peckham ◽  
Christine M Bond ◽  
Michael J Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Pilot Trial ◽  
Public Library ◽  
Feasibility Studies ◽  
Methodological Review ◽  
Pilot Trials ◽  
Trial Protocols ◽  
Randomised Controlled

ObjectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study designMethodological review.MethodsWe searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.ResultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.ConclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.

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