Randomised controlled trial comparing immobilisation in above-knee plaster of Paris to controlled ankle motion boots in undisplaced paediatric spiral tibial fractures

2021 ◽  
pp. emermed-2020-210299
Author(s):  
Kate Bradman ◽  
Katherine Stannage ◽  
Sharon O'Brien ◽  
Simon Green ◽  
Natasha Bear ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Fracture Healing ◽  
Treatment Time ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Personal Care ◽  
Ankle Motion ◽  
Time Points ◽  
Plaster Of Paris ◽  
Randomised Controlled

BackgroundManagement of common childhood spiral tibial fractures, known as toddler’s fractures, has not significantly changed in recent times despite the availability of immobilisation devices known as controlled ankle motion (CAM) boots. We compared standard therapy with these devices on quality-of-life measures.MethodsA prospective randomised controlled trial, comparing immobilisation with an above-knee plaster of Paris cast (AK-POP) with a CAM boot in children aged 1–5 years with proven or suspected toddler’s fractures presenting to a tertiary paediatric ED in Perth, Western Australia, between March 2018 and February 2020. The primary outcome measure was ease of personal care, as assessed by a Care and Comfort Questionnaire (eight questions scored from 0, very easy, to 8, impossible) completed by the caregiver and assessed during three treatment time-points and preintervention and postintervention. Secondary outcome measures included weight-bearing status as well as complications of fracture healing and number of pressure injuries.Results87 patients were randomised (44 CAM boot, median age 2 (IQR 1.5–2.3), 71% men; 43 AK-POP, median age 2 (IQR 1.7–2.8), 80% men), a significant difference in the care and comfort score was demonstrated at all treatment time-points; with the AK-POP group reporting greater personal care needs on assessment on day 2, day 7–10 and 4-week review (all p≤0.001). Weight-bearing status was significantly different at day 7–10 (77.5% CAM vs 53.8% AK-POP, p=0.027). There was no difference in fracture healing or pressure areas between the two treatment groups.ConclusionsImmobilisation of toddler’s fractures in a CAM boot allows faster return to activities of daily living and weight-bearing without any effect on fracture healing.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001311246).

scholarly journals Recovery of early postoperative muscle strength after deep neuromuscular block by means of ultrasonography with comparison of neostigmine versus sugammadex as reversal drugs: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043935
Author(s):  
Xuan Wang ◽  
Yingyuan Li ◽  
Chanyan Huang ◽  
Wei Xiong ◽  
Qin Zhou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Muscle Strength ◽  
Neuromuscular Blockade ◽  
Postoperative Period ◽  
Controlled Trial ◽  
Complete Recovery ◽  
Early Postoperative Period ◽  
Time Points ◽  
Muscle Groups ◽  
Randomised Controlled

IntroductionDespite the use of quantitative neuromuscular monitoring together with the administration of reversal drugs (neostigmine or sugammadex), the incidence of residual neuromuscular blockade defined as a train-of-four ratio (TOFr) <0.9 remains high. Even TOFr >0.9 cannot ensure adequate recovery of neuromuscular function when T1 height is not recovered completely. Thus, a mathematical correction of TOFr needs to be applied because the return of a normal TOFr can precede the return of a normal T1 twitch height. On the other hand, different muscles have different sensitivities to neuromuscular blockade agents; thus, complete recovery of one specific muscle group does not represent complete recovery of all other muscles. Therefore, our study aims to assess the muscle strength recovery of respiratory-related muscle groups by ultrasound and evaluate global strength using handgrip dynamometry in the early postoperative period when TOFr=0.9 and corrected TOFr (cTOFr)=0.9 with comparison of neostigmine versus sugammadex as reversal drugs.Methods and analysisThis study will be a prospective, single-blinded, randomised controlled trial involving 60 patients with American Society of Anesthesiologists physical status I–II and aged between 18 and 65 years, who will undergo microlaryngeal surgery. We will assess geniohyoid muscle, parasternal intercostal muscle, diaphragm, abdominal wall muscle and handgrip strength at four time points: before anaesthesia, TOFr=0.9, cTOFr=0.9 and 30 min after admission to the post anaesthesia care unit. Our primary objective will be to compare the effects of neostigmine and sugammadex on the recovery of muscle strength of different muscle groups in the early postoperative period when TOFr=0.9 and cTOFr=0.9. The secondary objective will be to observe the difference of muscle strength between the time points of TOFr=0.9 and cTOFr=0.9 to find out the clinical significance of cTOFr >0.9.Ethics and disseminationThe protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital, Sun Yat-sen University. The findings will be disseminated to the public through peer-reviewed scientific journals.Trial registration numberChiCTR2000033832.

scholarly journals Elastic-band resistance exercise or vibration treatment in combination with hydroxymethylbutyrate (HMB) supplement for management of sarcopenia in older people: a study protocol for a single-blinded randomised controlled trial in Hong Kong

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e034921 ◽  
Author(s):  
Simon Kwoon-Ho Chow ◽  
Yu-Ning Chim ◽  
Keith Yu-Kin Cheng ◽  
Chung-Yan Ho ◽  
Wing-Tung Ho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Muscle Strength ◽  
Older People ◽  
Controlled Trial ◽  
Elastic Band ◽  
Vibration Treatment ◽  
Time Points ◽  
Randomised Controlled

IntroductionSarcopenia is a geriatric syndrome characterised by progressive loss of skeletal muscle mass and function with risks of adverse outcomes and becomes more prevalent due to ageing population. Elastic-band exercise, vibration treatment and hydroxymethylbutyrate (HMB) supplementation were previously proven to have positive effects on the control of sarcopenia. The purpose of this study is to evaluate the effectiveness of elastic-band exercise or vibration treatment with HMB supplementation in managing sarcopenia. Our findings will provide a safe and efficient strategy to mitigate the progression of sarcopenia in older people and contribute to higher quality of life as well as improved long-term health outcomes of elderly people.Methods and analysisIn this single-blinded, randomised controlled trial (RCT), subjects will be screened for sarcopenia based on the Asian Working Group for Sarcopenia (AWGS) definition and 144 sarcopenic subjects aged 65 or above will be recruited. This RCT will have three groups evaluated at two time points to measure changes over 3 months—the control and the groups with combined HMB supplement and elastic-band resistance exercise or vibration treatment. Changes in muscle strength in lower extremity will be the primary outcome. Muscle strength in the upper extremity, gait speed, muscle mass (based on AWGS definition), functional performance in terms of balancing ability and time-up-and-go test and quality of life will be taken as secondary outcomes. In addition, each participant’s daily activity will be monitored by a wrist-worn activity tracker. Repeated-measures analysis of variance will be performed to compare within-subject changes between control and treatment groups at two time points of pretreatments and post-treatments.Ethics and disseminationThe procedures have been approved by the Joint CUHK-NTEC Clinical Research Management Office (Ref. CREC 2018.602) and conformed to the Declaration of Helsinki. Results will be disseminated through peer-reviewed publications, conferences and workshops.Trial registration numberNCT04028206.

scholarly journals Randomised controlled trial protocol for the PROTECT-CS Study: PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e037240
Author(s):  
Alexandra V Rose ◽  
Todd Duhamel ◽  
Chris Hyde ◽  
Dave E Kent ◽  
Jonathan Afilalo ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Postoperative Recovery ◽  
Primary Site ◽  
Trial Protocol ◽  
Time Points ◽  
Frail Patients ◽  
Randomised Controlled

IntroductionIn the past 20 years, the increasing burden of heart disease in an ageing population has resulted in cardiac surgery (CS) being offered to more frail and older patients with multiple comorbidities. Frailty and malnutrition are key geriatric syndromes that impact postoperative outcomes, including morbidity, mortality and prolonged hospital length of stay. Enhanced recovery protocols (ERPs), such as prehabilitation, have been associated with a reduction in complications after CS in vulnerable patients. The use of nutritional ERPs may enhance short-term and long-term recovery and mitigate frailty progression while improving patient-reported outcomes.Methods and analysisThis trial is a two-centre, double-blinded, placebo, randomised controlled trial with blinded endpoint assessment and intention-to-treat analysis. One-hundred and fifty CS patients will be randomised to receive either a leucine-rich protein supplement or a placebo with no supplemented protein. Patients will consume their assigned supplement two times per day for approximately 2 weeks pre-procedure, during in-hospital postoperative recovery and for 8 weeks following discharge. The primary outcome will be the Short Physical Performance Battery score. Data collection will occur at four time points including baseline, in-hospital (pre-discharge), 2-month and 6-month time points post-surgery.Ethics and disseminationThe University of Manitoba Biomedical Research Ethics Board (20 March 2018) and the St Boniface Hospital Research Review Committee (28 June 2019) approved the trial protocol for the primary site in Winnipeg, Manitoba, Canada. The second site’s (Montreal, Quebec) ethics has been submitted and pending approval from the Research Ethics and New Technology Development Committee for the Montreal Heart Institute (December 2020). Recruitment for the primary site started February 2020 and the second site will begin January 2021. Data gathered from the PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery Study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share findings with stakeholders who are positioned to implement evidence-informed change.Potential study impactMalnutrition and frailty play a crucial role in post-CS recovery. Nutritional ERPs are increasingly being recognised as a clinically relevant aspect of perioperative care. As such, this trial is to determine if leucine-rich protein supplementation at key intervals can mitigate frailty progression and facilitate enhanced postoperative recovery.Trial registration numberClinicalTrials.gov Registry (NCT04038294).

scholarly journals Randomised controlled trial of structured personal care of type 2 diabetes mellitus

BMJ ◽  
2001 ◽  
Vol 323 (7319) ◽  
pp. 970-970 ◽  
Author(s):  
N. d. F. Olivarius ◽  
H. Beck-Nielsen ◽  
A. H. Andreasen ◽  
M. Horder ◽  
P. A Pedersen
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Personal Care ◽  
Randomised Controlled

scholarly journals Transarticular tibiotalocalcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: protocol for a multicentre, prospective, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e026360
Author(s):  
Paul Tuckett ◽  
Matthew Hope ◽  
Kevin Tetsworth ◽  
Jerry Van De Pol ◽  
Catherine McDougall
Keyword(s):  
Randomised Controlled Trial ◽  
Elderly Population ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Weight Bearing ◽  
The Elderly ◽  
Primary Outcome Measure ◽  
Ankle Fractures ◽  
Randomised Controlled

IntroductionAnkle fractures are common in the elderly population. Surgical fixation is technically challenging and often results in complications due to high rates of osteoporosis and vascular disease. Open reduction and internal fixation (ORIF) often requires prolonged periods of non-weight bearing increasing the risks of complications. Tibiotalocalcaneal (TTC) nailing has been suggested as an alternative to ORIF which allows immediate weight bearing, and is suggested to result in fewer complications. This study aims to compare the two surgical techniques in the elderly population with ankle fractures.Methods and analysisThe study will be a multicentre, prospective, randomised controlled trial comparing ORIF to TTC nailing in 110 patients with ankle fractures aged 50 or above with a Charlson Comorbidity Index of greater than or equal to four. Participants and assessors will not be blinded to intervention. The primary outcome measure will be overall complication rate. Secondary outcomes include length of hospital stay, mobility at discharge, discharge destination, the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score, the Olerud-Molander Ankle Score, mortality rate, rate of secondary surgical interventions and number of blood transfusions required postoperatively. Our null hypothesis is that there is no clinically significant difference in the primary outcome measure between the two treatment groups.Ethics and disseminationThe study has been approved by Metro South Hospital and Health Services Human Research Ethics Committee (EC00167) (reference number HREC/17/QPAH/351).DiscussionCompletion of this trial will provide evidence on the effectiveness of TTC nailing versus ORIF in treatment of the elderly ankle fracture. If TTC nailing is found to result in superior outcomes, this trial has the capacity to change current clinical practice.Trial registration numberACTRN12617001588381;Pre-results andU1111-1203-1704.

scholarly journals Effect of a short message service (SMS) intervention on adherence to a physiotherapist-prescribed home exercise program for people with knee osteoarthritis and obesity: protocol for the ADHERE randomised controlled trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rachel K. Nelligan ◽  
Rana S. Hinman ◽  
Jessica Kasza ◽  
Sarah Schwartz ◽  
Alexander Kimp ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Exercise Program ◽  
Exercise Adherence ◽  
Home Exercise ◽  
Knee Oa ◽  
Home Based ◽  
Sms Intervention ◽  
Randomised Controlled

Abstract Background Knee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence. Methods We are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure. Discussion Findings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA. Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTRN12617001243303 Date/version: August 2019/two

Sign in / Sign up

Export Citation Format

Share Document