Knee osteoarthritis pendulum therapy: In vivo evaluation and a randomised, single-blind feasibility clinical trial.

Background: Exercise is recommended as the first-line management for knee osteoarthritis (KOA); however, it is difficult to determine which specific exercises are more effective. This study aimed to explore the potential mechanism and effectiveness of a leg-swinging exercise practiced in China, called 'KOA pendulum therapy' (KOAPT). Intraarticular hydrostatic and dynamic pressure (IHDP) are suggested to partially explain the signs and symptoms of KOA. As such this paper set out to explore this mechanism in vivo in minipigs and in human volunteers alongside a feasibility clinical trial. The objective of this study is 1) to analyze the effect of KOAPT on local mechanical and circulation environment of the knee in experimental animals and healthy volunteers; and 2) to test if it is feasible to run a large sample, randomized/single blind clinical trial. Methods: IHDP of the knee was measured in ten minipigs and ten volunteers (five healthy and five KOA patients). The effect of leg swinging on synovial blood flow and synovial fluid content depletion in minipigs were also measured. Fifty KOA patients were randomly divided into two groups for a feasibility clinical trial. One group performed KOAPT (targeting 1000 swings/leg/day), and the other performed walking exercise (targeting 4000 steps/day) for 12 weeks with 12 weeks of follow-up. Results: The results showed dynamic intra-articular pressure changes in the knee joint, increases in local blood flow, and depletion of synovial fluid contents during pendulum leg swinging in minipigs. The intra-articular pressure in healthy human knee joints was -11.32 ± 0.21 (cmH2O), whereas in KOA patients, it was -3.52 ± 0.34 (cmH2O). Measures were completed by 100% of participants in all groups with 95-98% adherence to training in both groups in the feasibility clinical trial. There were significant decreases in the Oxford knee score in both KOAPT and walking groups after intervention (p < 0.01), but no significant differences between the two groups. Conclusion: We conclude that KOAPT exhibited potential as an intervention to improve symptoms of KOA possibly through a mechanism of normalising mechanical pressure in the knee; however, optimisation of the method, longer-term intervention and a large sample randomized-single blind clinical trial with a minimal 524 cases are needed to demonstrate whether there is any superior benefit over other exercises. The translational potential of this article: The research aimed to investigate the effect of an ancient leg-swinging exercise on knee osteoarthritis. A minipig animal model was used to establish the potential mechanism underlying the exercise of knee osteoarthritis pendulum therapy, followed by a randomised, single-blind feasibility clinical trial in comparison with a commonly-practised walking exercise regimen. Based on the results of the feasibility trial, a large sample clinical trial is proposed for future research, in order to develop an effective exercise therapy for KOA.

A general theory of rehabilitation: Rehabilitation catalyses and assists adaptation to illness.

BACKGROUND: There is no general theory of rehabilitation, only definitions and descriptions, with the biopsychosocial model of illness as a structure. OBJECTIVE: To develop a general theory of rehabilitation that explains how healthcare rehabilitation changes outcomes and to evaluate its validity. NEED: A general rehabilitation theory would help research, improve services, increase understanding, modify resource allocation and explain some anomalies, such as how rehabilitation helps when no natural recovery occurs. BUILDING BLOCKS: People adapt to change throughout their lives. Illness is a change, and people adapt to their illness. Adaptation's purpose is to maintain an equilibrium in a person's life. The balanced components are related to Maslow's five needs: basic, safety, affiliation, status and self-fulfilment. The general theory of behaviour suggests that a person's behaviours change to maintain balance, regulated by a central homeostatic mechanism. THE THEORY: Rehabilitation aids adaptation to changes associated with illness through accurate diagnosis and formulation, catalysing adaptation, optimising the environment and assisting the person in making necessary changes by safely practising activities and teaching self-management. IMPLICATIONS: The theory makes the person the central active agent, emphasises the importance of the environment in facilitating adaptation, explains why all conditions may benefit, including progressive and static conditions, suggests that health can be equated to someone maintaining their equilibrium and explains why a small dose may be very effective. CONCLUSION: The general theory of rehabilitation emphasises the catalytic effects of rehabilitation in facilitating and guiding adaptation and suggests areas for research and improvement.

Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive-behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which 'downgraded' the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

Before choosing a uniform name for the PMR specialty, we must define the specialty.

In this commentary, I develop the recent proposal to choose a uniform name globally for our specialty ("A call for a single international name for the specialty"), suggesting it is premature and we must first agree on the core, central features characterizing a specialist. The question is, what is our specialty? The scope and content vary significantly between and within countries. If we can agree on the nature and scope of the specialty, a one-word name may arise that people and countries could choose to use.

Rehabilitation potential: A critical review of its meaning and validity.

BACKGROUND: The concept of rehabilitation potential emerged in 1950 as a way to select people for rehabilitation; it is also used to limit access to services. OBJECTIVE: To elucidate the meaning(s) of rehabilitation potential and whether it is valid in selecting patients for rehabilitation, whether as an inpatient, outpatient, or in the community. METHOD: A non-systematic review of how it has been used, a structured discussion of its potential meanings, an exploration of the evidence in support of selecting people who might benefit from rehabilitation, and a discussion of the concept of rehabilitation potential. FINDINGS: It has been used in several ways with two primary meanings: predicting a person's function at some later time; predicting who will gain additional improvement in outcome from being seen by a rehabilitation service. The concept is flawed because rehabilitation is a process, not a specific action; the effects anticipated after rehabilitation are not restricted to functional improvement; patient characteristics do not determine many essential outcomes. There is no evidence to guide the selection of patients for an assessment and formulation by a rehabilitation team. CONCLUSION: Rehabilitation potential, defined as data that gives the likelihood of additional benefit from receiving input from an expert rehabilitation service, is an illusion lacking any coherent definition, description, or evidence. Its use to limit access to rehabilitation is invalid. The solution is to offer all people not recently seen by an expert multi-professional rehabilitation team a full rehabilitation assessment and formulation, which will reveal what rehabilitation might achieve.

Moving on. A farewell from the last Editor-in-Chief who says: 'Rehabilitation is a way of thinking, not a way of doing'.

What is rehabilitation? From 1994 to 2021, while I was privileged to be Editor of Clinical Rehabilitation, I explored this in editorials. I also encouraged and selected submissions that considered, in one way or another, the central features of rehabilitation. Why? Because when I started in rehabilitation, the general attitude among doctors and other healthcare professionals was that rehabilitation was pleasant but with no evidence of effectiveness. Further, they did not think a doctor had a role to play and did not think there was anything special for rehabilitation experts to know or have skills in. In this editorial, I discuss how, as editor, I used my position to support and encourage the publication of articles that produced evidence, considered the conceptual and scientific basis of rehabilitation, and ultimately answered the above question. I illustrate this with a few specific papers published in Clinical Rehabilitation. After 30 years, I have concluded that the essential feature characterising rehabilitation is its way of thinking about the patient's problems and how to solve them. Rehabilitation is holistic, person-centred, and concerned about social integration rather than disease or disability. Moreover, there is a mass of evidence showing it benefits patients.

Management of traumatic brain injury: practical development of a recent proposal.

A recent article identified weaknesses in the management of patients with traumatic brain injury (TBI). The authors suggested some reasons but overlooked two of the reasons for the low quality of services: a lack of resources and a systemic failure to organise rehabilitation services. They suggested early involvement of a condition-specific service with a new 'neuroscience clinician' and additional neuro-navigators, but the evidence shows this approach does not work. Their proposal failed to acknowledge the neuroscience skills of existing rehabilitation medicine consultants and teams, and ignored the many non-TBI problems patients will have and the consequent need for expert rehabilitation input. We revise and develop their proposal, suggesting an alternative way to improve services. Rehabilitation teams should work in parallel with acute services and remain responsible for the rehabilitation of patients as they move through different settings. This suggested development of rehabilitation mirrors the development followed by geriatric medicine from 40 years ago.

Prolonged disorders of consciousness: A response to a "critical evaluation of the new UK guidelines."

BACKGROUND: In 2020, The London Royal College of Physicians published "Prolonged disorders of consciousness following sudden-onset brain injury: national clinical guidelines". In 2021, in the journal Brain, Scolding et al. published "a critical evaluation of the new UK guidelines". This evaluation focussed on one of the 73 recommendations in the National Clinical Guidelines. They also alleged that the guidelines were unethical. CRITICISMS: They criticised our recommendation not to use activation protocols using fMRI, electroencephalography, or Positron Emission Tomography. They claim these tests can (a) detect 'covert consciousness', (b) add predictive value and (c) should be part of routine clinical care. They also suggest that our guideline was driven by cost considerations, leading to clinicians deciding to withdraw treatment at 72 h. EVIDENCE: Our detailed review of the evidence confirms the American Academy of Neurology Practise Guideline (2018) and the European Academy of Neurology Guideline (2020), which agree that insufficient evidence supports their approach. ETHICS: The ethical objections are based on unwarranted assumptions. Our guideline does not make any recommendations about management until at least four weeks have passed. We explicitly recommend that expert assessors undertake ongoing surveillance and monitoring; we do not suggest that patients be abandoned. Our recommendation will increase the cost We had ethicists in the working party. CONCLUSION: We conclude the "critical evaluation" fails to provide evidence for their criticism and that the ethical objections arise from incorrect assumptions and unsupported interpretations of evidence and our guideline. The 2020 UK national guidelines remain valid.

Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation ('My Therapy'): protocol for a stepped-wedge cluster randomised trial.

BACKGROUND: Ensuring patients receive an effective dose of therapeutic exercises and activities is a significant challenge for inpatient rehabilitation. My Therapy is a self-management program which encourages independent practice of occupational therapy and physiotherapy exercises and activities, outside of supervised therapy sessions. METHODS: This implementation trial aims to determine both the clinical effectiveness of My Therapy on the outcomes of function and health-related quality of life, and cost-effectiveness per minimal clinically important difference (MCID) in functional independence achieved and per quality adjusted life year (QALY) gained, compared to usual care. Using a stepped-wedge cluster randomised design, My Therapy will be implemented across eight rehabilitation wards (inpatient and home-based) within two public and two private Australian health networks, over 54-weeks. We will include 2,160 patients aged 18 + years receiving rehabilitation for any diagnosis. Each ward will transition from the usual care condition (control group receiving usual care) to the experimental condition (intervention group receiving My Therapy in addition to usual care) sequentially at six-week intervals. The primary clinical outcome is achievement of a MCID in the Functional Independence Measure (FIM™) at discharge. Secondary outcomes include improvement in quality of life (EQ-5D-5L) at discharge, length of stay, 30-day re-admissions, discharge accommodation, follow-up rehabilitation services and adverse events (falls). The economic outcomes are the cost-effectiveness per MCID in functional independence (FIM™) achieved and per QALY gained, for My Therapy compared to usual care, from a health-care sector perspective. Cost of implementation will also be reported. Clinical outcomes will be analysed via mixed-effects linear or logistic regression models, and economic outcomes will be analysed via incremental cost-effectiveness ratios. DISCUSSION: The My Therapy implementation trial will determine the effect of adding self-management within inpatient rehabilitation care. The results may influence health service models of rehabilitation including recommendations for systemic change to the inpatient rehabilitation model of care to include self-management. Findings have the potential to improve patient function and quality of life, and the ability to participate in self-management. Potential health service benefits include reduced hospital length of stay, improved access to rehabilitation and reduced health service costs. TRIAL REGISTRATION: This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828&isReview=true ).

Defining rehabilitation: An exploration of why it is attempted, and why it will always fail.

THE PROBLEM: Over 187 definitions of rehabilitation exist, none widely agreed or used. Why? THE WORD: Words represent a core concept, with a penumbra of associated meanings. A word means what is agreed among those who use it. The precise meaning will vary between different groups. Words evolve, the meaning changing with use. Other words may capture some of the concepts or meanings. A DEFINITION: A definition is used to control the unstable, nebulous meaning of a word. It delineates, creating a boundary. A non-binary spectrum of meaning is transformed into binary categories: rehabilitation, or not rehabilitation. In clinical terms, it is a diagnostic test to identify rehabilitation. There are many different reasons for categorising something as rehabilitation. Each will need its own definition. CATEGORISATION: The ability of a definition to distinguish cases accurately must be validated by comparison with 'the truth'. If there were an external 'true' test to identify rehabilitation, a definition would not be needed. As with most concepts, the only truth is agreement by people familiar with the required distinction. Any definition will generate misclassification. People familiar with the required distinction will also need to resolve mis-categorisation. DESCRIPTION: An alternative is a 'descriptive definition', listing features over several domains which must be present. This fails logically. Rehabilitation is an emergent concept, more than the sum of its parts. CONCLUSION: A useful definition cannot be achieved because no definition will cover all needs, and a specific definition for a purpose will misclassify some cases.

Dual-task walking and automaticity after Stroke: Insights from a secondary analysis and imaging sub-study of a randomised controlled trial.

OBJECTIVE: To test the extent to which initial walking speed influences dual-task performance after walking intervention, hypothesising that slow walking speed affects automatic gait control, limiting executive resource availability. DESIGN: A secondary analysis of a trial of dual-task (DT) and single-task (ST) walking interventions comparing those with good (walking speed ⩾0.8 m s-1, n = 21) and limited (walking speed <0.79 m s-1, n = 24) capacity at baseline. SETTING: Community. SUBJECTS: Adults six-months post stroke with walking impairment. INTERVENTIONS: Twenty sessions of 30 minutes treadmill walking over 10 weeks with (DT) or without (ST) cognitive distraction. Good and limited groups were formed regardless of intervention received. MAIN MEASURES: A two-minute walk with (DT) and without (ST) a cognitive distraction assessed walking. fNIRS measured prefrontal cortex activation during treadmill walking with (DT) and without (ST) Stroop and planning tasks and an fMRI sub-study used ankle-dorsiflexion to simulate walking. RESULTS: ST walking improved in both groups (∆baseline: Good = 8.9 ± 13.4 m, limited = 5.3±8.9 m, Group × time = P < 0.151) but only the good walkers improved DT walking (∆baseline: Good = 10.4 ± 13.9 m, limited = 1.3 ± 7.7 m, Group × time = P < 0.025). fNIRS indicated increased ispilesional prefrontal cortex activation during DT walking following intervention (P = 0.021). fMRI revealed greater DT cost activation for limited walkers, and increased resting state connectivity of contralesional M1 with cortical areas associated with conscious gait control at baseline. After the intervention, resting state connectivity between ipsilesional M1 and bilateral superior parietal lobe, involved in integrating sensory and motor signals, increased in the good walkers compared with limited walkers. CONCLUSION: In individual who walk slowly it may be difficult to improve dual-task walking ability.Registration: ISRCTN50586966.

The future of rehabilitation in the United Kingdom National Health Service: Using the COVID-19 crisis to promote change, increasing efficiency and effectiveness.

THE PROBLEM: Rehabilitation services in the UK are inadequate, with insufficient capacity or flexibility to meet the needs of patients after Covid-19. HISTORY: Rehabilitation developed in a piecemeal way, focused on specific problems: spinal cord injury, burns, polio, stroke, back pain, equipment and adaptations etc. Rehabilitation is also provided using other names (e.g. intermediate care). Patients with complex needs do not fit easily within this system. SYSTEM FAILURE: After Covid-19, patients have problems that cross existing condition-specific and/or treatment-specific services. Covid-19 has exposed the lack of any coherent organisational principle underlying development or commissioning of rehabilitation services. Consequently, in order to have their needs met, patients either have to engage with two or more separate services or they receive good management for some problems and sub-optimal management for other problems. THE GOALS: The multitude of small specific services need to coalesce into an integrated service able to meet all the needs of any patient referred. Second, rehabilitation needs to be fully integrated into all healthcare services. A SOLUTION: The purpose of healthcare is to 'improve our health and well-being . . . to stay as well as we can to the end of our lives'. (NHS constitution) All healthcare services need to consider patients holistically, giving equal attention to disease, disability, and distress. Rehabilitation, acute care, mental health and palliative care services need to work in parallel to achieve this purpose. Healthcare providers, supported by commissioners and rehabilitation experts, could achieve structural and organisational change, meeting the needs of patients.

Immunotherapy to reduce frequency of urinary tract infections in people with neurogenic bladder dysfunction; a pilot randomised, placebo-controlled trial.

OBJECTIVE: To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom®) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction. DESIGN: A parallel-group, double-blind, randomized, placebo-controlled trial. SETTING: Patients at home, recruited through out-patient contact, social media and patient support groups. SUBJECTS: People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12 months. INTERVENTIONS: All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months. MAIN MEASURES: The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties. RESULTS: Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants. CONCLUSION: It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.

The effects of small-needle-knife therapy on pain and mobility from knee osteoarthritis: a pilot randomized-controlled study.

OBJECTIVE: To investigate the effect of small needle-knife therapy in people with painful knee osteoarthritis. DESIGN: Pilot randomised, controlled trial. SETTING: Rehabilitation hospital. SUBJECTS: In-patients with osteo-arthritis of the knee. INTERVENTIONS: Either 1 to 3 small needle-knife treatments over seven days or oral Celecoxib. All patients stayed in hospital three weeks, receiving the same mobility-focused rehabilitation. MEASURES: Oxford Knee Score (OKS), gait speed and kinematics were recorded at baseline, at three weeks (discharge) and at three-months (OKS only). Withdrawal from the study, and adverse events associated with the small needle knife therapy were recorded. RESULTS: 83 patients were randomized: 44 into the control group, of whom 10 were lost by three weeks and 12 at 3 months; 39 into the experimental group of whom eight were lost at three weeks and three months. The mean (SE) OKS scores at baseline were Control 35.86 (1.05), Exp 38.38 (0.99); at three weeks 26.64 (0.97) and 21.94 (1.23); and at three months 25.83 (0.91) and 20.48 (1.14) The mean (SE) gait speed at baseline was 1.07 (0.03) m/sec (Control) and 0.98 (0.03), and at three weeks was 1.14 (0.03) and 1.12 (0.03) (P < 0.05). Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months. CONCLUSIONS: Small needle-knife therapy added to standard therapy for patients with knee osteoarthritis, was acceptable, safe and reduced pain and improved global function on the Oxford Knee Score. Further research is warranted.

Rehabilitation after COVID-19: an evidence-based approach.

After severe COVID-19 disease, many patients will experience a variety of problems with normal functioning and will require rehabilitation services to overcome these problems. The principles of and evidence on rehabilitation will allow an effective response. These include a simple screening process; use of a multidisciplinary expert team; four evidence-based classes of intervention (exercise, practice, psychosocial support, and education particularly about self-management); and a range of tailored interventions for other problems. The large number of COVID-19 patients needing rehabilitation coupled with the backlog remaining from the crisis will challenge existing services. The principles underpinning vital service reconfigurations needed are discussed.

What attributes should a specialist in rehabilitation have? Seven suggested specialist Capabilities in Practice.

PROBLEM: Many services and professionals refer to themselves as providing rehabilitation. There is no agreed method for determining whether someone has specific expertise in rehabilitation. This makes it difficult for patients and payers to know whether professionals who claim to provide rehabilitation are specifically expert in rehabilitation. CONTEXT: Doctors have a medical speciality of rehabilitation. The medical training curriculum gives attributes that differentiate a rehabilitation specialist from other doctors. Until recently, these attributes were competencies to undertake activities associated with specialization. Apart from nurses, who have at least one, unofficial, curriculum identifying specific competencies, other professions involved in rehabilitation do not have any way to show specialization in rehabilitation. CAPABILITIES IN PRACTICE: The U.K. General Medical Council accredits specialist medical training. It has moved from specifying multiple practical clinical competencies to specifying fewer high-level 'Capabilities in Practice'. Six are generic to all doctors, eight identify the trained doctor as having specialist rehabilitation skills. This article adopts this approach to put forward seven generic and seven specialist capabilities to identify any professional as having special expertise in rehabilitation. The seven specialist capabilities centre on the biopsychosocial model of illness and multidisciplinary teamwork. Four of them could be used to define a specialist rehabilitation team. CONCLUSION: Seven capabilities identifying specialization in rehabilitation are put forward for discussion. They could form the basis of a formal recognition that any professional has additional expertise in rehabilitation. A validating authority would be needed to provide oversight and governance.

What is rehabilitation? An empirical investigation leading to an evidence-based description.

BACKGROUND: There is no agreement about or understanding of what rehabilitation is; those who pay for it, those who provide it, and those who receive it all have different interpretations. Furthermore, within each group, there will be a variety of opinions. Definitions based on authority or on theory also vary and do not give a clear description of what someone buying, providing, or receiving rehabilitation can actually expect. METHOD: This editorial extracts information from systematic reviews that find rehabilitation to be effective, to discover the key features and to develop an empirical definition. FINDINGS: The evidence shows that rehabilitation may benefit any person with a long-lasting disability, arising from any cause, may do so at any stage of the illness, at any age, and may be delivered in any setting. Effective rehabilitation depends on an expert multidisciplinary team, working within the biopsychosocial model of illness and working collaboratively towards agreed goals. The effective general interventions include exercise, practice of tasks, education of and self-management by the patient, and psychosocial support. In addition, a huge range of other interventions may be needed, making rehabilitation an extremely complex process; specific actions must be tailored to the needs, goals, and wishes of the individual patient, but the consequences of any action are unpredictable and may not even be those anticipated. CONCLUSION: Effective rehabilitation is a person-centred process, with treatment tailored to the individual patient's needs and, importantly, personalized monitoring of changes associated with intervention, with further changes in goals and actions if needed.