Physiotherapy - Research Publications
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ItemAn Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials(SPRINGER INT PUBL AG, 2022-12-28)BACKGROUND AND OBJECTIVE: Waste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates. METHODS: We parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial. RESULTS: Successful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials. CONCLUSIONS: This model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.
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ItemEvidence of ACL healing on MRI following ACL rupture treated with rehabilitation alone may be associated with better patient-reported outcomes: a secondary analysis from the KANON trial(BMJ PUBLISHING GROUP, 2022-11-03)OBJECTIVES: Evaluate the natural course of anterior cruciate ligament (ACL) healing on MRI within 5 years of acute ACL rupture and compare 2-year and 5-year outcomes based on healing status and treatment group. METHODS: Secondary analysis of 120 Knee Anterior Cruciate Ligament Nonsurgical vs Surgical Treatment (KANON) trial participants randomised to rehabilitation and optional delayed ACL reconstruction (ACLR) or early ACLR and rehabilitation. ACL continuity on MRI (Anterior Cruciate Ligament OsteoArthritis Score 0-2) was considered evidence of ACL healing. Outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS patient acceptable symptomatic state (PASS) and treatment failure criteria. Linear mixed models were used to estimate adjusted mean differences (95% CIs) in patient-reported sport and recreational function (KOOS-Sport/Rec) and quality of life (KOOS-QOL) at 2 and 5 years, between participants with MRI evidence of ACL healing and those who had (1) no evidence of ACL healing, (2) delayed ACLR or (3) early ACLR. RESULTS: MRI evidence of ACL healing at 2-year follow-up was observed in 16 of 54 (30%, 95% CI 19 to 43%) participants randomised to optional delayed ACLR. Excluding participants who had delayed ACLR, 16 of 30 (53%, 36-70%) participants managed with rehabilitation-alone displayed MRI evidence of ACL healing. Two-year outcomes were better in the healed ACL group (n=16) compared with the non-healed (n=14) (mean difference (95% CI) KOOS-Sport/Rec: 25.1 (8.6-41.5); KOOS-QOL: 27.5 (13.2-41.8)), delayed ACLR (n=24) (KOOS-Sport/Rec: 24.9 (10.2-39.6); KOOS-QOL: 18.1 (5.4-30.8)) and early ACLR (n=62) (KOOS-Sport/Rec: 17.4 (4.1-30.7); KOOS-QOL: 11.4 (0.0-22.9)) groups. Five-year KOOS-QOL was better in the healed versus non-healed group (25.3 (9.4-41.2)). Of participants with MRI evidence of ACL healing, 63-94% met the PASS criteria for each KOOS subscale, compared with 29-61% in the non-healed or reconstructed groups. CONCLUSIONS: MRI appearance of ACL healing after ACL rupture occurred in one in three adults randomised to initial rehabilitation and one in two who did not cross-over to delayed ACLR and was associated with favourable outcomes. The potential for spontaneous healing of the ACL to facilitate better clinical outcomes may be greater than previously considered. TRIAL REGISTRATION NUMBER: ISRCTN84752559.
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ItemImpact of current Australian paid parental leave on families of preterm and sick infants.(Wiley, 2022-11)AIM: Parents of preterm or sick infants are at increased risk of mental health problems. The financial stress associated with an infant's prolonged hospital stay can have an additional negative effect on families' wellbeing and child development. This study explores parent use of Australian paid parental leave (PPL) and the financial impact of having an infant requiring neonatal care. METHODS: Retrospective, cross-sectional, online survey study conducted from November 2020 to February 2021. Participants were parents of babies born from 1 January 2013, admitted to a neonatal intensive care unit or special care nursery in Australia. The survey explored use of Australian Government and private sector PPL, and financial stress. Parent-reported anxiety and depression were measured using the EuroQol Group 5D-5L Anxiety and Stress Subscale. RESULTS: Two hundred and thirty-one parents responded of which 93% had a preterm infant. Seventy-three percent of infants were hospitalised for more than 1 month, and 34% were readmitted to hospital within the first year following discharge home. Eighty-three percent of parents reported moderate, severe or extreme levels of anxiety or depression. Seventy-six percent reported that having a child in hospital had a moderate-very large financial impact on their family. Parents identified main costs to be travel, food, inability to work and direct medical costs. CONCLUSIONS: Having an infant born preterm or sick has significant emotional and financial implications for families. The current Australian Government PPL scheme does not adequately support parents of preterm or sick infants, and a change is urgently needed to improve outcomes for this vulnerable population.
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ItemTotal joint replacement may be a valuable treatment for Aboriginal and Torres Strait Islander people with osteoarthritis, but uptake is low(WILEY, 2022-08-13)BACKGROUND: Despite bearing a higher burden of osteoarthritis, little research has examined disparities in the access, utilisation and surgical outcomes associated with total joint replacement (TJR) among Aboriginal and Torres Strait Islander people. METHODS: We conducted a retrospective cohort study to compare the sociodemographic and clinical characteristics of all Aboriginal and Torres Strait Islander and non-Aboriginal patients who underwent primary hip and knee replacement at St Vincent's Hospital Melbourne between 1996 and 2019. RESULTS: A total of 10 277 primary total knee or hip replacements were performed in the 1996-2019 study period, of which 49 (0.5%) patients identified as either Aboriginal and/or Torres Strait Islander. Aboriginal and Torres Strait Islander patients were younger (61.7 ± 11.8 vs. 68.3 ± 10.3 years; P < 0.001), recorded higher Body Mass Index scores (median (IQR), 36.0 (29.5-41.4) vs. 30.8 (27.0-35.3); P < 0.001) and were more likely to experience multiple co-morbidities at the time of surgery. Despite these findings, Aboriginal and Torres Strait Islander patients did not experience higher complication rates and experienced comparable, clinically meaningful quality of life improvements 12-months post-surgery. CONCLUSIONS: TJR appears to be a valuable treatment option for Aboriginal and Torres Strait Islander people with end-stage osteoarthritis. Our study was limited by the small number of procedures conducted in patients who identify as Aboriginal and Torres Strait Islander. Further research is needed to understand why uptake of TJR by Aboriginal and Torres Strait Islander people is low.
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ItemThe effect of biomechanical foot-based interventions on patellofemoral joint loads during gait in adults with and without patellofemoral pain or osteoarthritis: a systematic review protocol(BMC, 2022-12-13)BACKGROUND: Patellofemoral pain is highly prevalent across the lifespan, and a significant proportion of people report unfavourable outcomes years after diagnosis. Previous research has implicated patellofemoral joint loading during gait in patellofemoral pain and its sequelae, patellofemoral osteoarthritis. Biomechanical foot-based interventions (e.g., footwear, insoles, orthotics, taping or bracing) can alter patellofemoral joint loads by reducing motions at the foot that increase compression between the patella and underlying femur via coupling mechanisms, making them a promising treatment option. This systematic review will summarise the evidence about the effect of biomechanical foot-based interventions on patellofemoral joint loads during gait in adults with and without patellofemoral pain and osteoarthritis. METHODS: MEDLINE (Ovid), the Cumulative Index to Nursing and Allied Health Literature CINAHL, The Cochrane Central Register of Controlled Trials (CENTRAL), SPORTdiscus (EBSCO) and Embase (Ovid) will be searched. Our search strategy will include terms related to 'patellofemoral joint', 'loads' and 'biomechanical foot-based interventions'. We will include studies published in the English language that assess the effect of biomechanical foot-based interventions on patellofemoral joint loads, quantified by patellofemoral joint pressure, patellofemoral joint reaction force and/or knee flexion moment. Two reviewers will independently screen titles and abstracts, complete full-text reviews, and extract data from included studies. Two reviewers will assess study quality using the Revised Cochrane Risk of Bias (RoB 2) tool or the Cochrane Risk Of Bias In Non-Randomized Studies - of Interventions (ROBINS-I) tool. We will provide a synthesis of the included studies' characteristics and results. If three or more studies are sufficiently similar in population and intervention, we will pool the data to conduct a meta-analysis and report findings as standardised mean differences with 95% confidence intervals. If a meta-analysis cannot be performed, we will conduct a narrative synthesis of the results and produce forest plots for individual studies. DISCUSSION: This protocol outlines the methods of a systematic review that will determine the effect of biomechanical foot-based interventions on patellofemoral joint loads. Our findings will inform clinical practice by identifying biomechanical foot-based interventions that reduce or increase patellofemoral joint loads, which may aid the treatment of adults with patellofemoral pain and osteoarthritis. TRIAL REGISTRATION: Registered with PROSPERO on the 4th of May 2022 (CRD42022315207).
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ItemA Randomised Controlled Trial of YOGa and Strengthening Exercise for Knee OsteoArthritis: Protocol for a Comparative Effectiveness Trial (YOGA Trial).(MDPI AG, 2022-10-12)Osteoarthritis (OA) is a common joint disorder for which there is no cure. Current treatments are suboptimal. Exercise is a core treatment for knee OA, with muscle strengthening exercise commonly recommended. Yoga is a mind-body exercise intervention that can improve flexibility, muscle strength, balance, and fitness and potentially reduce symptoms of OA. However, there is a scarcity of robust, high-quality conclusive evidence on the efficacy of yoga in knee OA. We are currently conducting the first randomised comparative effectiveness and cost-effectiveness trial of a yoga program compared with a strengthening exercise program in patients with symptomatic knee OA. This study protocol describes the design and conduct of this trial. The YOGA study is a phase III, single-centre, parallel, superiority, randomised, active-controlled trial which will be conducted in Hobart, Australia. One hundred and twenty-six participants (63 in each arm) aged over 40 years with symptomatic knee OA will be recruited from the community and randomly allocated to receive either a 24-week yoga program (3×/week) or a strengthening exercise program (3×/week). The primary outcome will be change in knee pain over 12 weeks, assessed using a 100 mm visual analogue scale (VAS). The secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life, gait speed, biomarkers, and others over 12 and 24 weeks. We will also assess whether the presence of neuropathic pain moderates the effects of yoga compared to strengthening exercise. Additional data, such as cost and resource utilization, will be collected for the cost-effectiveness analysis. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored throughout the study. Once completed, this trial will contribute to the knowledge of whether yoga can be used as a simple, effective, low-cost option for the management of knee OA, thus saving economic costs in the healthcare system.
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ItemAre cam morphology size and location associated with self-reported burden in football players with FAI syndrome?(WILEY, 2022-01-24)Cam morphology size and location might affect the severity of reported burden in people with femoroacetabular impingement (FAI) syndrome. We investigated the relationship between cam morphology size (i.e., alpha angle) and self-reported hip/groin burden (i.e., scores for the International Hip Outcome Tool-33 (iHOT-33) and Copenhagen Hip and Groin Outcome Score (HAGOS)), examined separately for the anteroposterior pelvis (AP) and Dunn 45° radiographs in football players with FAI syndrome. In total, 118 (12 women) subelite football (soccer or Australian football) players with FAI syndrome with cam morphology (alpha angle ≥60°) participated. One blinded assessor quantified superior and anterosuperior cam morphology size by measuring alpha angles for the AP and Dunn 45° radiographs, respectively. Linear regression models investigated relationships between alpha angle (continuous independent variable, separately measured for the AP and Dunn 45° radiographs) and iHOT-33 and HAGOS scores (dependent variables). Larger anterosuperior cam morphology (seen on the Dunn 45° radiograph) was associated with lower (i.e., worse) scores for the iHOT-Total, iHOT-Symptoms, iHOT-Job, and iHOT-Social subscales (unadjusted estimate range -0.553 to -0.319 [95% confidence interval -0.900 to -0.037], p = 0.002 to 0.027), but not the iHOT-Sport (p = 0.459) nor any HAGOS scores (p = 0.110 to 0.802). Superior cam morphology size (measured using the AP radiograph) was not associated with any iHOT-33 or HAGOS scores (p = 0.085 to 0.975). Larger anterosuperior cam morphology may be more relevant to pain and symptoms in football players with FAI syndrome than superior cam morphology, warranting investigation of its effects on reported burden and hip disease over time.
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ItemPathways to participation in gymnastics: Understanding the experiences of families of children with disability.(University Rehabilitation Institute Republic of Slovenia, 2022-03-04)Introduction: The aim of this study was to understand the experiences of families of children with disability with participating in gymnastics, to inform how more supportive gymnastics environments can be created. Patients and Methods: Sequential explanatory mixed-methods study design. Eligible participants were parents or carers of children/young people with disability (any type, up to 25 years) who currently participate in, had participated in, or had attempted to participate in gymnastics in Victoria, Australia, in the last 3 years. Participants completed an online survey, with selected participants purposively invited to undertake a semi-structured interview. Sixty-eight parents provided survey responses, with eight interviews conducted. Quantitative survey data were analysed using descriptive statistics. Qualitative survey and interview data were analysed using inductive thematic analysis. All data were mixed to create a conceptual framework. Themes and the framework underwent member checking with parent advisors and interview participants. Results: Five key themes emerged: (1) Tailored, accessible and supportive facilities and programs make a difference, (2) An explicitly inclusive club culture helps young people get involved and stay involved, (3) Coach knowledge about engaging children with disability is valued, (4) Enjoyment and recognition of achievement are key facilitators of ongoing participation, and (5) Gymnastics has physical and social benefits. The conceptual framework integrated themes into stages along the participation pathway. Conclusion: Many participation-related interventions target children with disability and their families. Conversely, these findings provide guidance to gymnastics clubs on how to become more inclusive and supportive environments at each stage of participation.
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ItemPromoting clinical best practice in a user-centred design study of an upper limb rehabilitation robot(Taylor & Francis, 2021-01-01)Purpose: Despite their promise to increase therapy intensity in neurorehabilitation, robotic devices have not yet seen mainstream adoption. Whilst there are a number of contributing factors, it is obvious that the treating clinician should have a clear understanding of the objectives and limitations of robotic device use. This study sought to explore how devices can be developed to support a clinician in providing clinical best practice. Methods and Materials: A user-centred design study of a robotic device was conducted, involving build-then-use iterations, where successive iterations are built based on feedback from the use cycle. This work reports results of an analysis of qualitative and quantitative data describing the use of the robotic device in the clinical sessions, and from a focus group with the treating clinicians. Results and Conclusions: The data indicated that use of the device did not result in patient goal-setting and may have resulted in poor movement quality. Therapists expected a higher level of autonomy from the robotic device, and this may have contributed to the above problems. These problems can and should be addressed through modification of both the study design and device to provide more explicit instructions to promote clinical best practice. Implications for Rehabilitation: • Encouraging clinical best practice when using evaluating prototype devices within a clinical setting is important to ensure that best practice is maintained - and can be achieved through both study and device design • Support from device developers can significantly improve the confidence of therapists during the use of that device in rehabilitation, particularly with new or prototype devices • End effector-based robotic devices for rehabilitation show potential for a wide variety of patient presentations and capabilities.
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ItemTransfer of the supinator nerve to the posterior interosseous nerve for hand opening in tetraplegia through an anterior approach(SAGE PUBLICATIONS LTD, 2021-03-05)We report a retrospective series of 44 transfers in 26 patients in whom a functioning supinator nerve was transferred to a paralyzed posterior interosseous nerve through a single, anterior approach to re-animate hand opening in mid-cervical tetraplegia. Eighteen patients underwent concurrent nerve or tendon transfers to re-animate grasp and/or pinch through the same anterior incision. We evaluated the strength of the innervated muscle at mean follow-up of 24 months (range 12-27). The strength attained in our patients was equivalent to the strength after the transfer through a posterior approach reported in the literature. Nineteen of our patients were satisfied with the hand opening procedure. First webspace opening was the only variable to correlate with patient satisfaction. We conclude that the anterior approach yields similar results to the posterior approach and has the advantage of allowing easier access for simultaneously performing nerve or tendon transfers to reconstruct grasp and pinch.Level of evidence: IV.