scholarly journals Rehabilitation of executive function in chronic paediatric brain injury: a randomized controlled trial

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Anne E. Brandt ◽  
Torun G. Finnanger ◽  
Ruth E. Hypher ◽  
Torstein B. Rø ◽  
Eva Skovlund ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Executive Function ◽  
Brain Injury ◽  
Daily Life ◽  
Controlled Trial ◽  
Executive Dysfunction ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background Impaired executive functions (EFs, i.e., purposeful, goal-directed behaviour) cause significant disability after paediatric acquired brain injury (pABI) warranting efficient interventions. Goal Management Training (GMT) is a metacognitive protocol proven effective for executive dysfunction in adults. This pre-registered, blinded, parallel-randomized controlled trial evaluated efficacy of a paediatric adaptation (pGMT) compared to a psychoeducative control (paediatric Brain Health Workshop, pBHW) to improve EF. Methods Children aged 10 to 17 years with pABI (e.g., traumatic brain injury, brain tumour), ≥ 1 year post-onset or ended treatment, with parent-reported EF complaints were eligible. Participants were randomized (computer-algorithm) to either group-based pGMT (n = 38) or pBHW (n = 38). The active control was tailored to keep non-specific factors constant. Thus, both treatments comprised of 7 sessions at hospitals over 3 consecutive weeks, followed by 4 weeks of telephone counselling of participants, parents, and teachers. Parent-reported daily life EF, assessed by the questionnaire Behavior Rating Inventory of Executive Function (BRIEF; Behavioral Regulation Index (BRI) and Metacognition Index (MI)), were co-primary outcomes 6 months post-intervention. Secondary outcomes included neuropsychological tests and a complex naturalistic task (Children’s Cooking Task). Results Seventy-three participants (96%) completed allocated interventions and 71 (93%) attended the 6-month follow-up. The results demonstrated no significant difference in effectiveness for the two interventions on parent-reported EF: For BRIEFBRI, mean (SD) raw score for pGMT was 42.7 (8.8) and 38.3 (9.3) for pBHW. Estimated difference was − 2.3 (95% CI − 5.1 to 0.6). For BRIEFMI, the corresponding results were 80.9 (20.4) for GMT and 75.5 (19.3) for pBHW. Estimated difference was − 1.4 (95% CI −8.5 to 5.8). In performance-based tests, pGMT was associated with improved inhibition and executive attention, while pBHW was associated with fewer errors in the naturalistic task. Conclusions In pABI, metacognitive training (pGMT) did not demonstrate additional effectiveness on parent-reported daily life EF at 6-month follow-up, when compared to a psychoeducative control. Both interventions were well-tolerated and demonstrated distinct improvements at different EF assessment levels. To conclude on pGMT efficacy, larger studies are needed, including further investigation of appropriate assessment levels and possible differences in effect related to treatment duration, developmental factors, and injury characteristics. Trial registration ClinicalTrials.gov, NCT0321534211, 11 July 2017

Enhancing adoptive parenting: A randomized controlled trial

2010 ◽  
Vol 15 (4) ◽  
pp. 529-542 ◽  
Author(s):  
Alan Rushton ◽  
Elizabeth Monck ◽  
Morven Leese ◽  
Paul McCrone ◽  
Jessica Sharac
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Adoptive Parents ◽  
Control Group ◽  
Parenting Interventions ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Significant Difference

The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a “services as usual” group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference ( p < 0.007) was found for “satisfaction with parenting” in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters’ satisfaction with parenting in the intervention group compared to the routine service group.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

scholarly journals Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-11 ◽  
Author(s):  
Caroline A. Smith ◽  
Caroline A. Crowther ◽  
Oswald Petrucco ◽  
Justin Beilby ◽  
Hannah Dent
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Effect ◽  
Controlled Trial ◽  
Acupuncture Group ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Menstrual Pain ◽  
Randomized Controlled ◽  
Significant Difference

We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture and control ). At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR) 0.72, 95% confidence interval (CI) 0.53–1.00, . Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, , and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, , but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

scholarly journals Study protocol of a randomized controlled trial of home-based computerized executive function training for children with cerebral palsy

2019 ◽  
Author(s):  
María García-Galant ◽  
montse blasco ◽  
Lee Reid ◽  
kerstin Pannek ◽  
David Leiva ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Executive Function ◽  
Brain Plasticity ◽  
Controlled Trial ◽  
Brain Mri ◽  
Executive Dysfunction ◽  
Training Programme ◽  
Magnetic Resonance Images ◽  
Randomized Controlled ◽  
Home Based

IntroductionCerebral palsy (CP) is frequently associated with specific cognitive impairments, such as executive dysfunction which are related to participation and quality of life (QOL). The proposed study will examine whether a computerized executive function (EF) training programme could provide superior benefits for executive functioning, participation, QOL and brain plasticity, as compared to usual care.Methods and analysisA single-blind randomized controlled trial (RCT) design will be performed. Thirty children with CP aged 8 to 12 years will participate in a home-based computerized multi-modal executive training programme (12 weeks, 5 days a week, 30 min a day training, total dose= 30h). Thirty children with CP matched by age, sex, motor and intelligence quotient (IQ) will compose the waitlist group. Cognitive, behavioural, emotional, participation and QOL measures will be obtained at three time points: before, immediately after and 9 months after completing the training. Additionally, structural and functional (resting state) magnetic resonance images (MRI) will be obtained in a subsample of 15 children from each group. Outcomes between groups will be compared following standard principles for RCTs.The study will test whether the cognitive training programme exerts a positive effect not only on neuropsychological and daily functioning of children with CP but also on other measures such as participation and QOL. We will also use brain MRI to test brain functional and structural changes after the intervention.If this on-line and home-based training programme proves effective, it could be a cost-effective intervention with short- and long-term effects on EF, participation or QOL in CP.

scholarly journals The Influence of Prenatal DHA Supplementation on Individual Domains of Behavioral Functioning in School-Aged Children: Follow-Up of a Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2996
Author(s):  
Jacqueline F. Gould ◽  
Peter J. Anderson ◽  
Lisa N. Yelland ◽  
Robert A. Gibson ◽  
Maria Makrides
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Fetal Brain ◽  
Executive Dysfunction ◽  
Behavioral Functioning ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Randomized Controlled ◽  
Trial Entry

Docosahexaenoic acid (DHA) accumulates in the fetal brain during pregnancy and is thought to have a role in supporting neurodevelopment. We conducted a multicenter, double-blind, randomized controlled trial in women with a singleton pregnancy who were <21 weeks’ gestation at trial entry. Women were provided with 800 mg DHA/day or a placebo supplement from trial entry until birth. When children reached seven years of age, we invited parents to complete the Strengths and Difficulties Questionnaire (SDQ), the Behavior Rating Inventory of Executive Function (BRIEF), and the Conners 3rd Edition Attention-Deficit Hyperactivity Disorder (ADHD) Index to assess child behavior and behavioral manifestations of executive dysfunction. There were 543 parent–child pairs (85% of those eligible) that participated in the follow-up. Scores were worse in the DHA group than the placebo group for the BRIEF Global Executive, Behavioral Regulation and Metacognition Indexes, and the Shift, Inhibit, Monitor, Working Memory, and Organization of Materials scales, as well as for the Conners 3 ADHD index, and the SDQ Total Difficulties score, Hyperactivity/Inattention score, and Peer Relationship Problems score. In this healthy, largely term-born sample of children, prenatal DHA supplementation conferred no advantage to childhood behavior, and instead appeared to have an adverse effect on behavioral functioning, as assessed by standardized parental report scales.

scholarly journals One day versus three days’ antibiotic prophylaxis in joint arthroplasty. A prospective randomized controlled trial

2021 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
Mahmoud Elsaqa ◽  
Mahmoud A. Karim ◽  
Walid Ebeid ◽  
Mohamed Youness
Keyword(s):  
Randomized Controlled Trial ◽  
Antibiotic Prophylaxis ◽  
Antimicrobial Prophylaxis ◽  
Controlled Trial ◽  
Joint Arthroplasty ◽  
University Hospitals ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Objectives: The objectives of the study was to compare the effectiveness of 1 day versus 3 days post-operative antibiotic prophylaxis in decreasing surgical site infection (SSI) rate after arthroplasty surgery. Methods: A prospective, randomized controlled trial was conducted over 1 year, in Cairo University Hospitals. The study included adult patients, who were scheduled for arthroplasty. Sixty patients were divided into two groups, 30 patients in each. The first group of patients received cefazolin for 1 day postoperatively (1-day group) and the other group for 3 days postoperatively (3-days group). Patients were randomized using the sealed opaque envelope method. Results: There were 32 females and 28 males. The mean patient age was 52 years (range 20–85 years). Wound infection developed in four cases (one case from the 1-day group and three cases from the 3-days group). All infections occurred within the early post-operative period, and completely resolved after proper management. Correlating the SSI to the type of surgery, operative time, the associated medical co-morbidities, and the duration of antimicrobial prophylaxis was not statistically significant. Conclusion: This study suggests that there is no significant difference in the prevalence of SSI between 1 day and 3 days of antimicrobial prophylaxis after primary joint arthroplasty within the average post-operative follow-up period of 3 months.

scholarly journals Eye Movement Technique to Improve Executive Function in Patients With Stroke: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Wen He ◽  
Yazheng Ji ◽  
Xiating Wei ◽  
Fan Wang ◽  
Feng Xu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Executive Function ◽  
Reaction Time ◽  
Eye Movement ◽  
Controlled Trial ◽  
Executive Dysfunction ◽  
Wisconsin Card Sorting Test ◽  
Single Center ◽  
Randomized Controlled

Objective: To investigate the efficacy of eye movement technique for the treatment of executive dysfunction of patients with stroke.Methods: This was a prospective, single-blinded, randomized, controlled, single-center clinical trial conducted from June 2018 to December 2019 in patients with stroke. The patients were randomized 1:1 to the routine (conventional management) and eye-move group (routine management plus eye movement technique: 5-min goal management training, 5-min computer-aided working memory, and 10 min of inhibitory control training and set conversion training). The intervention lasted 6 weeks, followed by a 4-week follow-up. The primary endpoint was the Behavioral Assessment of the Dysexecutive Syndrome (BADS) score. The secondary endpoints mainly included the Montreal Cognitive Assessment (MoCA), Wisconsin Card Sorting Test (WCST), and modified Barthel Index (MBI) scores.Results: Sixty-four patients were enrolled (32/group). After the 6-week intervention, the BADS and WCST scores of the eye-move group were significantly improved than those of the routine group (all P &lt; 0.05), but the effects were attenuated in certain subscores after follow-up (all P &gt; 0.05). The MoCA and MBI scores of the eye-move group were significantly higher, and the reaction time was significantly lower than those of the routine group at 4 weeks after the intervention (all P &lt; 0.05). After follow-up, the MBI scores of the eye-move group were still higher than that of the routine group (P &lt; 0.001), but there were no differences for MoCA scores and reaction time (both P &gt; 0.05).Conclusion: The eye movement technique could improve the executive function of patients with stroke. These results have to be confirmed.This was a prospective, single-blinded, randomized, controlled, single-center clinical trial (ChiCTR2000036393).Clinical Trial Registration: [www.chictr.org.cn], identifier [ChiCTR2000036393].

Promoting Forgiveness at a Christian College: A Comparison of the REACH Forgiveness and Forgive for Good Methods

2020 ◽  
Vol 48 (2) ◽  
pp. 154-165
Author(s):  
Loren L. Toussaint ◽  
Brandon J. Griffin ◽  
Everett L. Worthington ◽  
Mitchell Zoelzer ◽  
Frederic Luskin
Keyword(s):  
Randomized Controlled Trial ◽  
Community Intervention ◽  
Controlled Trial ◽  
Christian College ◽  
Combined Effects ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Forgiveness Intervention ◽  
Luther College

The present study is the first randomized, controlled trial comparing REACH Forgiveness and Forgive for Good, two of the most commonly used approaches to promote forgiveness. Additionally, the combined effects of psychoeducation and a community forgiveness intervention were examined. Psychoeducation participants were 99 Luther College students randomly assigned to six hours of one of two types of forgiveness training led by undergraduate facilitators or a control condition. The community forgiveness intervention involved campus-wide modifications to the environment that were difficult for most students to not notice. Unforgiveness and forgiveness were measured at pre-, post-intervention, and two-month follow-up. Both forgiveness groups reported decreased unforgiveness and increased forgiveness pre- to post-intervention, and these gains were maintained at follow-up. Both methods were found to be equally effective, can be taught by undergraduates, and were effective in tandem with a community intervention.

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