A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson's disease: a study protocol for a randomised controlled trial.

BACKGROUND: Parkinson's disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals' needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive. METHODS/DESIGN: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation. PRIMARY OUTCOME: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK. DISCUSSION: The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.

Does physical activity change following hip and knee replacement? Matched case-control study evaluating Physical Activity Scale for the Elderly data from the Osteoarthritis Initiative.

OBJECTIVES: To determine whether physical activity measured using the Physical Activity Scale for the Elderly (PASE), changes during the initial 24 months post-total hip (THR) or knee replacement (TKR), and how this compares to a matched non-arthroplasty cohort. DESIGN: Case-controlled study analysis of a prospectively collected dataset. SETTING: USA community-based. PARTICIPANTS: 116 people post-THR, 105 people post-TKR compared to 663 people who had not undergone THR or TKR, or had hip or knee osteoarthritis. Cohorts were age-, gender- and BMI-matched. MAIN OUTCOME MEASURES: Physical activity assessed using the 12-item PASE at 12 and 24 months post operatively. RESULTS: There was no significant difference in total PASE score between pre-operative to 12 months (mean: 136 vs 135 points; p=0.860) or 24 months following THR (mean: 136 vs 132 points; p=0.950). Whilst there was no significant difference in total PASE score from pre-operative to 12 months post-TKR (126 vs 121 points; p=0.930), by 24 months people following TKR reported significantly greater physical activity (126 vs 142 points; p=0.040). There was no statistically significant difference in physical activity between the normative matched and THR (p≥0.140) or TKR (p≥0.060) cohorts at 12 or 24 months post joint replacement. CONCLUSIONS: Physical activity is not appreciably different to pre-operative levels at 12 or 24 months post-THR, but was greater at 24 months following TKR. Health promotion strategies are needed to encourage greater physical activity participation following joint replacement, and particularly targeting those who undergo THR.

Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial.

OBJECTIVE: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. DESIGN: single-blind parallel group RCT. PARTICIPANTS: Residual arm deficit less than 12 months post-stroke. INTERVENTIONS: Reach-to-Grasp training in 14 one-hour therapist's visits over 6 weeks, plus one hour self-practice per day (total 56 hours). CONTROL: Usual care. MAIN MEASURES: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. RESULTS: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. CONCLUSIONS: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

UK survey of occupational therapist's and physiotherapist's experiences and attitudes towards hip replacement precautions and equipment.

BACKGROUND: Total hip replacement (THR) is one of the most common orthopaedic procedures in the United Kingdom (UK). Historically, people following THR have been provided with hip precautions and equipment such as: raised toilet seats and furniture rises, in order to reduce the risks of dislocation post-operation. The purpose of this study was to determine current practices in the provision of these interventions in the UK for people following primary THR. METHODS: A 27-question, self-administered online survey was developed and distributed to UK physiotherapists and occupational therapists involved in the management of people following primary THR (target respondents). The survey included questions regarding the current practices in the provision of equipment and hip precautions for THR patients, and physiotherapist's and occupational therapist's attitudes towards these practices. The survey was disseminated through print and web-based/social media channels. RESULTS: 170 health professionals (87 physiotherapists and 83 occupational therapists), responded to the survey. Commonly prescribed equipment in respondent's health trusts were raised toilet seats (95 %), toilet frames and rails (88 %), furniture raises (79 %), helping hands/grabbers (77 %), perching stools (75 %) and long-handled shoe horns (75 %). Hip precautions were routinely prescribed by 97 % of respondents. Hip precautions were most frequently taught in a pre-operative group (52 % of respondents). Similarly equipment was most frequently provided pre-operatively (61 % respondents), and most commonly by occupational therapists (74 % respondents). There was variability in the advice provided on the duration of hip precautions and equipment from up to 6 weeks post-operatively to life-time usage. CONCLUSIONS: Current practice on hip precautions and provision of equipment is not full representative of clinician's perceptions of best care after THR. Future research is warranted to determine whether and to whom hip precautions and equipment should be prescribed post-THR as opposed to the current 'blanket' provision of equipment and movement restriction provided in UK practice.

Attentional focus of feedback for improving performance of reach-to-grasp after stroke: a randomised crossover study.

OBJECTIVE: To investigate whether feedback inducing an external focus (EF) of attention (about movement effects) was more effective for retraining reach-to-grasp after stroke compared with feedback inducing an internal focus (IF) of attention (about body movement). It was predicted that inducing an EF of attention would be more beneficial to motor performance. DESIGN: Crossover trial where participants were assigned at random to two feedback order groups: IF followed by EF or EF followed by IF. SETTING: Research laboratory. PARTICIPANTS: Forty-two people with upper limb impairment after stroke. INTERVENTION: Participants performed three reaching tasks: (A) reaching to grasp a jar; (B) placing a jar forwards on to a table; and (C) placing a jar on to a shelf. Ninety-six reaches were performed in total over one training session. MAIN OUTCOME MEASURES: Kinematic measures were collected using motion analysis. Primary outcome measures were movement duration, peak velocity of the wrist, size of peak aperture and peak elbow extension. RESULTS: Feedback inducing an EF of attention produced shorter movement durations {first feedback order group: IF mean 2.53 seconds [standard deviation (SD) 1.85]; EF mean 2.12 seconds (SD 1.63), mean difference 0.41 seconds; 95% confidence interval -0.68 to 1.5; P=0.008}, an increased percentage time to peak deceleration (P=0.01) when performing Task B, and an increased percentage time to peak velocity (P=0.039) when performing Task A compared with feedback inducing an IF of attention. However, an order effect was present whereby performance was improved if an EF of attention was preceded by an IF of attention. CONCLUSIONS: Feedback inducing an EF of attention may be of some benefit for improving motor performance of reaching in people with stroke in the short term; however, these results should be interpreted with caution. Further research using a randomised design is recommended to enable effects on motor learning to be assessed.

Blind outcome assessment: the development and use of procedures to maintain and describe blinding in a pragmatic physiotherapy rehabilitation trial.

OBJECTIVES: (1) To develop trial protocols which promote the achievement of blind outcome assessment. (2) To report outcome assessor beliefs regarding group allocation at follow-up assessments. (3) To document and describe instances of unblinding occurring during the trial to assist and inform rehabilitation researchers and clinicians. DESIGN: Prospective longitudinal observational study. SETTING: An NHS Hospital Trust specializing in orthopaedic surgery. SUBJECTS: One hundred and seven patients participating in a prospective pragmatic randomized controlled trial investigating physiotherapy rehabilitation following total knee arthroplasty, plus three outcome assessors. INTERVENTIONS: A protocol was developed using available research and designed to minimize instances of unblinding during a physiotherapy rehabilitation trial. Administrative, office, patient and research staff procedures were included. MAIN MEASURES: Trial questionnaires measured blind outcome assessment responses at 3 and 12 months post surgery. The outcome assessor kept a field diary recording the events surrounding instances of unblinding. Data underwent descriptive and content analysis. RESULTS: Blind outcome assessment was believed successful for n = 74 (81.32%) assessments at 3-month follow-up, and n = 83 (91.21%) at 12 months. Forty instances (n = 28 participants) of unblinding were described in the field diary. While the main cause of unblinding was participants telling the outcome assessor, in 12.5% of events the assessor drew the wrong conclusion regarding group allocation. Not all unblinding events were remembered at subsequent assessments, even in this relatively small trial. CONCLUSIONS: Blind outcome assessment was considered achievable in this trial. Specific trial protocols enabled blinding beliefs to be reported and instances of unblinding to be described.

Treadmill training for individuals with multiple sclerosis: a pilot randomised trial.

This pilot study investigated whether 4 weeks of aerobic treadmill training in individuals with multiple sclerosis (MS) improved mobility and reduced fatigue. Individuals with MS were recruited to this prospective, randomised controlled trial. Individuals were assessed at baseline, week 7 and 12 with a 10 metre timed walk, a 2 minute walk, the Rivermead Mobility Index, and the Fatigue Severity Scale. After a pre-assessment familiarisation session and a baseline assessment, individuals were randomly allocated to an initial intervention or delayed intervention group. Treadmill training consisted of 4 weeks of supervised aerobic exercise delivered weeks 3-6 in the immediate group and 8-11 in the delayed group. Of the initial 19 recruits, 16 individuals completed the study. There was a significant difference in walking endurance between the delayed and immediate groups at baseline (p<0.05). On reassessment in week 7, decreases in 10 metre walk time were found in both groups, which was significant in the immediate group (p<0.05). The 2 minute walk distance significantly increased in both groups (p<0.05). In the training group, reassessed at week 12 after training ceased, there was a return towards baseline scores. No significant changes in fatigue scores were found. This study showed that in individuals with MS, aerobic treadmill training is feasible and well tolerated. Walking speed and endurance increased following training with no increase in reported fatigue. Detraining occurred in the period following training. A larger randomised clinical trial is warranted.

Change in stroke incidence, mortality, case-fatality, severity, and risk factors in Oxfordshire, UK from 1981 to 2004 (Oxford Vascular Study).

BACKGROUND: The incidence of stroke is predicted to rise because of the rapidly ageing population. However, over the past two decades, findings of randomised trials have identified several interventions that are effective in prevention of stroke. Reliable data on time-trends in stroke incidence, major risk factors, and use of preventive treatments in an ageing population are required to ascertain whether implementation of preventive strategies can offset the predicted rise in stroke incidence. We aimed to obtain these data. METHODS: We ascertained changes in incidence of transient ischaemic attack and stroke, risk factors, and premorbid use of preventive treatments from 1981-84 (Oxford Community Stroke Project; OCSP) to 2002-04 (Oxford Vascular Study; OXVASC). FINDINGS: Of 476 patients with transient ischaemic attacks or strokes in OXVASC, 262 strokes and 93 transient ischaemic attacks were incident events. Despite more complete case-ascertainment than in OCSP, age-adjusted and sex-adjusted incidence of first-ever stroke fell by 29% (relative incidence 0.71, 95% CI 0.61-0.83, p=0.0002). Incidence declined by more than 50% for primary intracerebral haemorrhage (0.47, 0.27-0.83, p=0.01) but was unchanged for subarachnoid haemorrhage (0.83, 0.44-1.57, p=0.57). Thus, although 28% more incident strokes (366 vs 286) were expected in OXVASC due to demographic change alone (33% increase in those aged 75 or older), the observed number fell (262 vs 286). Major reductions were recorded in mortality rates for incident stroke (0.63, 0.44-0.90, p=0.02) and in incidence of disabling or fatal stroke (0.60, 0.50-0.73, p<0.0001), but no change was seen in case-fatality due to incident stroke (17.2% vs 17.8%; age and sex adjusted relative risk 0.85, 95% CI 0.57-1.28, p=0.45). Comparison of premorbid risk factors revealed substantial reductions in the proportion of smokers, mean total cholesterol, and mean systolic and diastolic blood pressures and major increases in premorbid treatment with antiplatelet, lipid-lowering, and blood pressure lowering drugs (all p<0.0001). INTERPRETATION: The age-specific incidence of major stroke in Oxfordshire has fallen by 40% over the past 20 years in association with increased use of preventive treatments and major reductions in premorbid risk factors.

Effect of experience of severe stroke on subjective valuations of quality of life after stroke.

Previous work suggests that the quality of life associated with severe disability after stroke is rated very poorly by members of the public, often as being worse than death. Other evidence suggests that experience of illness alters perceptions of its severity. This was tested for severe stroke. Eleven patients with severely disabling stroke, but able to complete a standard gamble interview, 22 age and sex matched controls, and 20 health professionals participated. A standard gamble interview was carried out to determine the quality of life (utility) associated with three hypothetical scenarios representing mild, moderate, and severe stroke, and current health. A sample was retested for reliability, and comparisons were made with other measures of health status. All three subject groups showed wide variation in the utilities they attached to each of the scenarios. The control subjects' valuations were lower than those of either patients or staff members, especially for moderate stroke (median 0.30, 0.73, and 0.68 respectively). There were weak to moderate correlations between utilities and other measures of health status including the Barthel index (r=0.51) and Rivermead mobility score (r=0.24). Test retest-reliability was modest (reliability coefficient 0.75), but indicators of the internal validity of the results were good. In conclusion, it cannot be assumed that general population valuations are valid for patient groups. In clinical practice it is unsafe to make any assumption about subjective quality of life after stroke, due to the wide range of valuations given, although many people rate severe and moderate stroke at least as bad as death.

The scope for rehabilitation in severely disabled stroke patients.

PURPOSE: To argue the case that patients who are severely disabled by stroke may benefit from rehabilitation. To identify critical areas where more research may be helpful. METHOD: Discussion of four negative views which could be cited as drawbacks to rehabilitation in this group. These are: (1) that patients with severe stroke do not recover; (2) that they are too ill to receive rehabilitation; (3) that rehabilitation is ineffective even when possible; and (4) that even if rehabilitation is effective, it is not cost-effective. RESULTS: There is little work in this area. There are problems with measurement of disability in this group. None of the four negative views are supported by current evidence, and what little evidence there is provides grounds for optimism that further work could be worthwhile. CONCLUSIONS: Specific recommendations for further work include: (1) the development of better measurement scales; (2) to determine the cost of care of severely disabled stroke patients; (3) to gain a better appreciation of the value of changes in disability states; and (4) to perform an overview analysis of rehabilitation interventions examining the degree to which severity of disability affects the response to treatment.

Single blind randomized controlled trial of visual feedback after stroke: effects on stance symmetry and function.

A number of before and after and single case design studies of visual feedback have shown improvements in stance symmetry after stroke, an associated improvement in function has been demonstrated. This study examines this promising technique further using a single-blind controlled trial. Twenty-six patients were recruited from a register of consecutive admissions and randomized into treatment and control groups. Both groups received additional therapy, only the treatment group received visual feedback. Assessments were carried out independently. Significant improvements were seen in the treatment group in measures of stance symmetry and sway and motor and ADL function. Between group differences had disappeared at three months. The results indicate that feedback training incorporated into functional physiotherapy treatment can improve stance symmetry and sway. Transfer of training was indicated by improvements in ADL and gross motor function. Three months later the improvement was maintained, but did not automatically continue without treatment.

Falls, sway, and symmetry of weight-bearing after stroke.

This study examines the relationship between falls, postural sway, stance symmetry, and length of hospital admission after stroke. Side of stroke, age, and sex differences are noted. A consecutive sample of 92 stroke patients underwent two assessments, four months apart, at between two and nine months post-stroke. Measurements of weight distribution and sway were made on the Nottingham Balance Platform. Any falls were recorded. A significant relationship was found between sway values at the first assessment and the number of falls (r = 0.27, p less than 0.01). Sway values improved with recovery (z = 2.9, p less than 0.01). Stance symmetry was significantly related to length of stay (r = 0.27, p less than 0.01) and age (r = 0.28, p less than 0.01), but not to falls. A significant difference was found between the weight distribution of right- and left-sided hemiplegias (t = 8.2, p less than 0.001) and stance symmetry improved with recovery (z = 2.9, p less than 0.01). No sex differences were apparent. This suggests that stance symmetry is another index of stroke severity, but that sway and falls frequency are not. However, an important relationship between sway and falls was revealed.