A Randomized Controlled Trial of Two Types of In-Shoe Orthoses in Children with Flexible Excess Pronation of the Feet

2007 ◽  
Vol 28 (6) ◽  
pp. 715-723 ◽  
Author(s):  
Deirdre Whitford ◽  
Adrian Esterman
Keyword(s):  
Controlled Trial ◽  
Group Analysis ◽  
Treatment Groups ◽  
Custom Made ◽  
Foot Pronation ◽  
Trends Over Time ◽  
Baseline Characteristics ◽  
High Level ◽  
And Control ◽  
Exercise Efficiency

Background: Orthoses for children with flexible excess pronation are estimated to cost Australian parents millions of dollars per year; however, there is no high-level evidence that orthoses improve function or reduce pain. Methods: A randomized parallel, single-blinded, controlled trial of custom-made and ready-made orthoses was conducted in children between the ages of 7 and 11 years with bilateral flexible excess pronation. The diagnosis was based on calcaneal eversion and navicular drop. Outcomes included gross motor proficiency, self-perception, exercise efficiency, and pain. Measurements were taken at baseline, and at 3 and 12 months. Of the 178 children who participated at baseline, 160 continued to the end of the trial. Results: After randomization, baseline characteristics were similar between the three treatment groups (custom-made, ready-made, and control). Statistical modeling demonstrated that although for most outcome measures there were statistically significant trends over time, none of the group comparisons were statistically significant. A sub-group analysis of those presenting with pain found no significant differences at 3 or 12 months. Conclusions: This study found no evidence to justify the use of in-shoe orthoses in the management of flexible excess foot pronation in children.

Prototyping an autonomous delivery vehicle

2018 ◽  
Vol 66 (2) ◽  
pp. 160-182
Author(s):  
Benjamin C. Heinrich ◽  
Thorsten Luettel ◽  
Dennis Fassbender ◽  
Patrick Burger ◽  
Felix Ebert ◽  
...  
Keyword(s):  
Test Facility ◽  
Sensor Calibration ◽  
Software Components ◽  
Delivery Vehicle ◽  
Planning And Control ◽  
Custom Made ◽  
Position And Orientation ◽  
High Level ◽  
Control Modules ◽  
And Control

AbstractIn this paper, we describe the hardware and software components of a fully autonomous prototype delivery vehicle. Equipped with a robotic arm, the demonstrator is capable of delivering packages and picking up new ones by interacting with custom-made delivery boxes. As highly accurate positioning w. r. t. a box is required for successful handover of packages, we track the pose (position and orientation) of the box using a high-resolution on-board camera. The resulting estimate is relayed to our planning and control modules, which ensure that the vehicle reaches its required pose with centimeter-level accuracy.In order to deliver packages, the car needs to autonomously navigate our test facility, avoiding static and dynamic obstacles while obeying simple traffic rules. As one focus is on the practical challenges encountered when building a prototype, we cover issues ranging from sensor calibration and system identification to perception, planning, control, and the implementation of high-level behaviors. While some of the proposed solutions to these problems are not necessarily novel, they allowed us to demonstrate the vehicle’s capabilities after a development phase of less than 12 months.

Randomized Controlled Trial of Interventions for Young People at Ultra-High Risk of Psychosis: Study Design and Baseline Characteristics

2009 ◽  
Vol 43 (9) ◽  
pp. 818-829 ◽  
Author(s):  
Lisa J. Phillips ◽  
Barnaby Nelson ◽  
Hok Pan Yuen ◽  
Shona M. Francey ◽  
Magenta Simmons ◽  
...  
Keyword(s):  
High Risk ◽  
Young People ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Treatment Groups ◽  
Mixed Support ◽  
Ultra High Risk ◽  
Supportive Counselling ◽  
Baseline Characteristics ◽  
The Impact

Objective: Intervention during the pre-psychotic period of illness holds the potential of delaying or even preventing the onset of a full-threshold disorder, or at least of reducing the impact of such a disorder if it does develop. The first step in realizing this aim was achieved more than 10 years ago with the development and validation of criteria for the identification of young people at ultra-high risk (UHR) of psychosis. Results of three clinical trials have been published that provide mixed support for the effectiveness of psychological and pharmacological interventions in preventing the onset of psychotic disorder. Method: The present paper describes a fourth study that has now been undertaken in which young people who met UHR criteria were randomized to one of three treatment groups: cognitive therapy plus risperidone (CogTher + Risp: n = 43); cognitive therapy plus placebo (CogTher + Placebo: n = 44); and supportive counselling + placebo (Supp + Placebo; n = 28). A fourth group of young people who did not agree to randomization were also followed up (monitoring: n = 78). Baseline characteristics of participants are provided. Results and conclusion: The present study improves on the previous studies because treatment was provided for 12 months and the independent contributions of psychological and pharmacological treatments in preventing transition to psychosis in the UHR cohort and on levels of psychopathology and functioning can be directly compared. Issues associated with recruitment and randomization are discussed.

Evolution of the randomized controlled trial (RCT) in oncology over three decades

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6515-6515 ◽  
Author(s):  
C. M. Booth ◽  
D. W. Cescon ◽  
L. Wang ◽  
I. F. Tannock ◽  
M. K. Krzyzanowska
Keyword(s):  
Primary Endpoint ◽  
Effect Size ◽  
Response Rate ◽  
Controlled Trial ◽  
For Profit ◽  
Survival Endpoints ◽  
Trends Over Time ◽  
And Control ◽  
Median Rate ◽  
Over Time

6515 Background: The RCT is the gold standard for establishing new therapies in oncology. Here we document changes with time in design, results, author conclusions and sponsorship. Methods: Reports of RCTs evaluating systemic therapy for breast, colorectal (CRC) and non-small cell lung cancer (NSCLC) published 1975–2004 in 6 major journals were reviewed. Two authors independently abstracted data regarding trial design, effect size and author conclusions. Author conclusions were assigned a score from 1 to 7: 4/7 for a neutral statement, 7/7 and 1/7 for strong endorsement of experimental and control arm respectively. For each study the effect size for the primary endpoint was converted to a summary measure: hazard ratio [HR] for survival endpoints and relative risk [RR] for response rate. Descriptive statistics were used to analyze trends over time. Results: 326 eligible RCTs were included (48% breast, 24% CRC, 28% NSCLC). There was a significant increase in the number and size of RCTs (see Table ). Median rate of accrual increased from 7 patients/month in 1975–84 to 14 patients/month in 1995–2004 (p<0.001). There was an increase in multicenter (55 to 95%, p<0.001), international trials (26 to 52%, p<0.001) and for-profit sponsorship over time (6 to 57%, p<0.001). There was increasing use of survival (13 to 48%,) and decreasing use of response rate (32 to 14%) as primary endpoint (p<0.001). Authors have become more likely to strongly endorse the experimental arm despite no change in effect size over time (p=0.005). Studies sponsored by for-profit organizations were more likely to strongly endorse the experimental agent than studies not sponsored by for-profit groups (median author score 6/7 vs. 4/7, p<0.001). Conclusions: RCTs in oncology have become more common, larger, and are more likely to be sponsored by industry. Authors of modern RCTs are more likely to strongly endorse novel therapies despite no increase in the relative benefit of interventions. For-profit sponsorship is associated with stronger endorsement of the experimental arm. No significant financial relationships to disclose. [Table: see text]

Effectiveness of two tobacco cessation methods among TB patients

2022 ◽  
Vol 26 (1) ◽  
pp. 12-17
Author(s):  
S. Malhotra ◽  
V. Mohanty ◽  
A. Y. Balappanavar ◽  
N. Sharma ◽  
A. Khanna ◽  
...  
Keyword(s):  
Tobacco Cessation ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Study Groups ◽  
Adverse Outcomes ◽  
Control Group ◽  
Treatment Groups ◽  
Integrated Intervention ◽  
Randomised Controlled ◽  
And Control

BACKGROUND: Tobacco and TB are the world´s two greatest public health problems. Exposure to tobacco has been shown to be associated with higher risk of acquiring TB and adverse outcomes such as relapse and TB mortality.OBJECTIVE: To assess and compare self-reported tobacco quit status and biochemically verified cotinine levels among TB patients at different time intervals among two study groups.METHODS: A cluster, randomised controlled trial was conducted on TB patients attending DOTS centres in Delhi, India, who reported using tobacco in any form. Participants were assigned into one of two treatment groups. Centres were randomly assigned to two intervention groups: 1) integrated intervention using behavioural counselling with nicotine replacement therapy (NRT) gum, and 2) intervention using behavioural counselling alone (50 each in intervention and control group). The subjects were followed at Week 1, Month 1, Month 3 and Month 6 for tobacco cessation.RESULTS: At the end of 6 months, patients who received the integrated intervention had significantly higher rate of success in quitting tobacco than those who received the conventional TB treatment alone (78.7% vs. 57.8%; P < 0.03).CONCLUSION: DOTS with tobacco use dependence treatment was successful in our study in helping TB patients to quit tobacco dependence and should therefore be offered to every tobacco user.

Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes

2009 ◽  
Vol 15 (3) ◽  
pp. 125-128 ◽  
Author(s):  
Robert SH Istepanian ◽  
Karima Zitouni ◽  
Diane Harry ◽  
Niva Moutosammy ◽  
Ala Sungoor ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Controlled Trial ◽  
Group Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Technical Problems ◽  
Intention To Treat ◽  
Patients With Diabetes ◽  
And Control

We conducted a randomized controlled trial using mobile health technology in an ethnically diverse sample of 137 patients with complicated diabetes. Patients in the intervention group ( n = 72) were trained to measure their blood glucose with a sensor which transmitted the readings to a mobile phone via a Bluetooth wireless link. Clinicians were then able to examine and respond to the readings which were viewed with a web-based application. Patients in the control arm of the study ( n = 65) did not transmit their readings and received care with their usual doctor in the outpatient and/or primary care setting. The mean follow-up period was 9 months in each group. The default rate was higher in the patients in the intervention arm due to technical problems. In an intention-to-treat analysis there were no differences in HbA1c between the intervention and control groups. In a sub-group analysis of the patients who completed the study, the telemonitoring group had a lower HbA1c than those in the control group: 7.76% and 8.40%, respectively ( P = 0.06).

Potential explanations for control group benefit

2012 ◽  
Vol 9 (5) ◽  
pp. 588-595 ◽  
Author(s):  
Linda O Nichols ◽  
Jennifer L Martindale-Adams ◽  
Robert Burns ◽  
Marshall J Graney ◽  
Jeffrey K Zuber ◽  
...  
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Control Group ◽  
Study Participation ◽  
Moderating Factors ◽  
Perceived Benefit ◽  
Nonspecific Factors ◽  
Baseline Characteristics ◽  
Group Change ◽  
And Control

Background Estimating effectiveness of clinical interventions depends on detecting differences between the responses of intervention and control groups. The outcome, intervention, and moderating factors all may influence the between group change. The absence of a clinically or statistically meaningful difference may also result from control group improvement due to nonspecific factors such as participants’ perception of attention, positive regard, expectations, desire to please, and therapeutic alliance with the care provider. Purpose We examined perceived benefit and sources of benefit for control caregivers who participated in the CONNECT randomized controlled trial of a dementia caregiving intervention. Methods After the final scheduled data collection in CONNECT, control group participants were asked whether they believed they benefited from study participation. Those who reported benefit were asked to describe the benefit received. Data were analyzed qualitatively. Results Of 60 available control caregivers, 82% reported a perceived benefit from study participation in five areas: getting information about dementia and caregiving; having someone to talk to and feeling supported; receiving understanding and validation of feelings; knowledge that others were in similar situations; and perceived appreciation of own abilities. Control caregivers who reported benefit were less burdened and depressed and spent less time on duty at baseline than those who did not report benefit. From caregivers’ responses, we have identified the assessment battery, both content and time spent in data collection, as a possible mechanism of action for benefit. Limitations Study limitations include the better baseline characteristics of the control caregivers who reported benefit, the sample size of benefit control caregivers, the possibility of perceptions of benefit being a function of social desirability, and the lack of a similar question about benefit being asked of intervention caregivers. Conclusions These findings suggest that the outcome assessment questionnaires used in this and similar trials may be an intervention of sorts for caregiver participants in the control group. Caregivers who are less distressed may benefit more from the attention provided during assessment. These findings underscore the importance of asking caregivers how they are doing. For researchers, there is a need to develop innovative ways to assess outcomes to avoid unintended benefit of assessments.

scholarly journals Design of a Hyper-Redundant Robot and Teleoperation Using Mixed Reality for Inspection Tasks

Sensors ◽  
2020 ◽  
Vol 20 (8) ◽  
pp. 2181 ◽  
Author(s):  
Andrés Martín-Barrio ◽  
Juan Jesús Roldán-Gómez ◽  
Iván Rodríguez ◽  
Jaime del Cerro ◽  
Antonio Barrientos
Keyword(s):  
Degrees Of Freedom ◽  
Mixed Reality ◽  
Control Strategies ◽  
Redundant Robots ◽  
Spatial Understanding ◽  
Custom Made ◽  
Inspection Tasks ◽  
High Level ◽  
And Control ◽  
Immersive Technologies

Hyper-redundant robots are highly articulated devices that present numerous technical challenges such as their design, control or remote operation. However, they offer superior kinematic skills than traditional robots for multiple applications. This work proposes an original and custom-made design for a discrete and hyper-redundant manipulator. It is comprised of 7 sections actuated by cables and 14 degrees of freedom. It has been optimized to be very robust, accurate and capable of moving payloads with high dexterity. Furthermore, it has been efficiently controlled from the actuators to high-level strategies based on the management of its shape. However, these highly articulated systems often exhibit complex shapes that frustrate their spatial understanding. Immersive technologies emerge as a good solution to remotely and safely teleoperate the presented robot for an inspection task in a hazardous environment. Experimental results validate the proposed robot design and control strategies. As a result, it is concluded that hyper-redundant robots and immersive technologies should play an important role in the near future of automated and remote applications.

scholarly journals Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Xuan Yin ◽  
Jian Xu ◽  
Bo Dong ◽  
Jie Ma ◽  
Zeqin Chen ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Sham Acupuncture ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Treatment Groups ◽  
Sleep Parameters ◽  
And Control

Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression.Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture), control A group (superficial acupuncture at sham points), and control B group (sham acupuncture). All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD), and Self-Rating Depression Scale (SDS). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up.Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21) and is registered withChiCTR-IIR-16008058.

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