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Aim  To determine if constraint‐induced movement therapy (CIMT) is more effective than bimanual training (BIM) in improving upper limb activity outcomes for children with congenital hemiplegia in a matched‐pairs randomized trial. Method  Sixty‐three children (mean age 10.2, SD 2.7, range 5–16y; 33 males, 30 females), 16 in Manual Ability Classification System level I, 46 level II, and 1 level III and 16 in Gross Motor Function Classification level I, 47 level II) were randomly allocated to either CIMT or BIM group day camps (60 hours over 10 days). The Melbourne Assessment of Unilateral Upper Limb Function assessed unimanual capacity of the impaired limb and Assisting Hand Assessment evaluated bimanual coordination at baseline, 3 and 26 weeks, scored by blinded raters. Results  After concealed random allocation, there was no baseline difference between groups. CIMT had superior outcomes compared with BIM for unimanual capacity at 26 weeks (estimated mean difference [EMD] 4.4, 95% confidence interval [CI] 2.2–6.7; p<0.001). There was no other significant difference between groups post‐intervention. Both groups demonstrated significant improvements in bimanual performance at 3 weeks, with gains maintained by BIM at 26 weeks (EMD 2.3; 95% CI 0.6–4.0; p=0.008). Interpretation  Overall, there were only small differences between the two training approaches. CIMT yielded greater changes in unimanual capacity of the impaired upper limb compared with BIM. Results generally reflect specificity of practice, with CIMT improving unimanual capacity and BIM improving bimanual performance. Considerable inter‐individual variation in response to either intervention was evident. Future research should consider serial sequencing unimanual then BIM approaches to optimize upper limb outcomes for children with congenital hemiplegia.

Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2·4–15·0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1·8–14·2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). A short period of immobilisation in a below-knee cast or Aircast results in faster recovery than if the patient is only given tubular compression bandage. We recommend below-knee casts because they show the widest range of benefit. National Co-ordinating Centre for Health Technology Assessment.

Objective: To investigate the long-term effects of the ‘transfer package’ in constraint-induced movement therapy, which is an optional protocol to facilitate actual use of the trained affected arm in activities of daily living. Design: A pilot quasi-randomized controlled trial with a blinded single assessor with six-month follow-up. Setting: Hospitalized care at university hospital. Subjects: Twenty-one post-stroke patients were quasi-randomized to either a group with transfer package during constraint-induced movement therapy or a control group (without transfer package). Interventions: The transfer package group received 4.5 hours of intensive task training and 0.5 hours of transfer package whereas the control group received 5.0 hours of intensive task training per day during 10 consecutive weekdays. Main measures: Arm function was measured with Fugl-Meyer Assessment and Amount of Use score of Motor Activity Log. Results: Twenty-three patients were quasi-randomized, but data from two patients were missing from the long-term follow-up. Both groups showed increase in arm function postintervention. However, at six months’ follow-up only the transfer package group showed consistent increase in arm function (with transfer package group versus control group; Fugl-Meyer Assessment, mean (± SD) from 48.6 ± 7.8 (preintervention) to 55.7 ± 4.5 (postintervention) and 59.0 ± 3.6 (six months postintervention) versus from 49.1 ± 5.5 to 52.8 ± 6.0 and 53.3 ± 4.9, P= 0.003; Amount of Use scale of Motor Activity Log, mean from 1.3 ± 0.55 (preintervention) to 2.12 ± 0.55 (postintervention) and 2.79 ± 0.98 (six months postintervention) versus from 1.18 ± 0.70 to 1.61 ± 0.54 and 1.65 ± 0.68, P= 0.002). Conclusions: Our results confirmed the long-term effects of the transfer package in constraint-induced movement therapy.

Objective: To clarify whether modified constraint-induced movement therapy provides greater improvement than intensive bimanual training both for motor functions and spontaneous use of the paretic arm and hand in everyday life activities. Design: Randomized controlled, single-blind trial. Setting: Inpatient paediatric rehabilitation clinic. Subjects: Forty-seven children with unilateral cerebral palsy or other non-progressive hemiplegia (aged 3.3–11.4 years) were randomly assigned to either a modified constraint-induced movement programme (kid-CIMT) or intensive bimanual training. Interventions: Patients in the kid-CIMT group received 60 hours of unilateral constraint-induced and 20 hours of bimanual training over four weeks. Patients in the bimanual treatment group received 80 hours of bimanual training over four weeks. Main outcome measures: Melbourne Assessment of Unilateral Upper Limb Function and Assisting Hand Assessment. Results: Modified constraint-induced therapy provided a significantly better outcome for isolated motor functions of the paretic arm than bimanual training (gain in Melbourne Assessment, percent score: 6.6 vs. 2.3, P= 0.033). Regarding spontaneous use both methods led to similar improvement (gain in Assisting Hand Assessment, percent score: 6.2 vs. 4.6, P= 0.579). More-disabled children showed greater improvement than less-disabled ones (correlation with Assisting Hand Assessment pretreatment score r = −0.40). Age did not affect treatment outcome. Conclusions: Modified constraint-induced movement therapy can improve isolated functions of the hemiplegic arm better than intensive bimanual training, but regarding spontaneous hand use in everyday life both methods lead to similar improvement. Improvements are generally greater in more impaired children. Age does not affect outcome.

ObjectiveTo investigate thermal balance of infants in a Mongolian winter, and compare the effects of traditional swaddling with an infant sleeping-bag in apartments or traditional tents (Gers).DesignA substudy within a randomised controlled trial.SettingCommunity in Ulaanbaatar, Mongolia.SubjectsA stratified randomly selected sample of 40 swaddled and 40 non-swaddled infants recruited within 48 h of birth.InterventionSleeping-bags and baby outfits of total thermal resistance equivalent to that of swaddled babies.Outcome measureDigital recordings of infants’ core, peripheral, environmental and microenvironmental temperatures at 30-s intervals over 24 h at ages 1 month and 3 months.ResultsIn Gers, indoor temperatures varied greatly (<0–>25°C), but remained between 20°C and 22°C, in apartments. Despite this, heavy wrapping, bed sharing and partial head covering, infant core and peripheral temperatures were similar and no infants showed evidence of significant heat or cold stress whether they were swaddled or in sleeping-bags. At 3 months, infants in sleeping-bags showed the ‘mature’ diurnal pattern of a fall in core temperature after sleep onset, accompanied by a rise in peripheral temperature, with a reverse pattern later in the night, just before awakening. This pattern was not related to room temperature, and was absent in the swaddled infants, suggesting that the mature diurnal pattern may develop later in them.ConclusionsNo evidence of cold stress was found. Swaddling had no identifiable thermal advantages over sleeping-bags during the coldest times, and in centrally heated apartments could contribute to the risk of overheating during the daytime.Trial registration numberISRTN01992617.

Objective: To determine the effect of therapist-based constraint-induced therapy at home on motor performance, daily function and reaching control for children with cerebral palsy. Design: A single-blinded, randomized controlled trial. Subjects: Forty-seven children (23 boys; 24 girls) with unilateral cerebral palsy, aged 6–12 years, were randomized to constraint-induced therapy (n = 24) or traditional rehabilitation (n = 23). Interventions: Constraint-induced therapy involved intensive functional training of the more affected arm while the less affected arm was restrained. Traditional rehabilitation involved functional unilateral and bilateral arm training. Both groups received individualized therapist-based interventions at home for 3.5–4 hours/day, two days a week for four weeks. Main measures: Motor performance and daily function were measured by the Peabody Developmental Motor Scale, Second Edition and the Pediatric Motor Activity Log. Reaching control was assessed by the kinematics of reaction time, movement time, movement unit and peak velocity. Results: There were larger effects in favour of constraint-induced therapy on motor performance, daily function, and some aspects of reaching control compared with traditional rehabilitation. Children receiving constraint-induced therapy demonstrated higher scores for Peabody Developmental Motor Scale, Second Edition – Grasping (pretest mean ± SD, 39.9 ± 3.1; posttest, 44.1 ± 2.8; P < 0.001), Pediatric Motor Activity Log (pretest, 1.8 ± 0.3; posttest, 2.5 ± 0.3; P < 0.001) and shorter reaction time, normalized movement time (P < 0.001) and higher peak velocity (P = 0.004) of reaching movement. Conclusions: Constraint-induced therapy induced better grasping performance, daily function, and temporal and spatiotemporal control of reaching in children with unilateral cerebral palsy than traditional rehabilitation.

Background Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany. Methods/Design The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents’ quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed. Conclusions We expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme. Trial registration ClinicalTrials.gov: NCT02341898

Introduction Exercise is beneficial to learning. The purpose of this research was to determine whether an episode of aerobic exercise prior to practice improves the acquisition and retention of laparoscopic skills in the fundamentals of laparoscopic surgery (FLS) simulator. Methods Baseline maximal physical fitness (VO2 max), performance on peg transfer (PT), pattern cut (PC), and intracorporeal suture (ICS) were measured for FLS naïve undergraduates. 2 Weeks later, participants were randomized into exercise ( E ) and control ( C ) groups. C did unrelated work for 40 min and then practiced PT and PC for 10 min, and ICS for 15 min. Final scores were recorded. In E , participants ran on a treadmill for 20 min at 60 % of their VO2 max. After a 15 min cool down, they engaged in identical FLS simulator training as group C . Both groups completed the NASA task load index (TLX) to assess workload. Retention was recorded 2 months after the training session. Groups were compared using t tests, χ 2 and Wilcoxon rank tests. p  < 0.05 was considered significant. Results There were 52 participants (22 in C ; 30 in E ) with high physical fitness at baseline. Demographics between the groups were similar at baseline. There were no differences in VO2 max and scores on the three tasks at baseline (all p values NS). There was no statistical significance between the scores of the C and E groups at the training session and retention, except for higher PT scores in the E group after the training session. Conclusion In physically fit, surgically naïve students, one bout of aerobic exercise enhanced immediate learning of simple FLS skills but did not have an impact on more complex skills or on retention. The use of exercise in the surgical curriculum, or as a learning tool, warrants further investigation regarding how best to apply it.

Background Although the authors of a Cochrane Review on seclusion and mechanical restraint concluded that \"there is a surprising and shocking lack of published trials\" on coercive interventions in psychiatry, there are only few instruments that can be applied in trials. Furthermore, as main outcome variable safety, psychopathological symptoms, and duration of an intervention cannot meet the demand to indicate subjective suffering and impact relevant to posttraumatic stress syndromes. An instrument used in controlled trials should assess the patients' subjective experiences, needs to be applicable to more than one intervention in order to compare different coercive measures and has to account for the specific psychiatric context. Methods The primary version of the questionnaire comprised 44 items, nine items on restrictions to human rights, developed on a clinical basis, and 35 items on stressors, derived from patients' comments during the pilot phase of the study. An exploratory factor analysis (EFA) using principal axis factoring (PAF) was carried out. The resulting factors were orthogonally rotated via VARIMAX procedure. Items with factor loadings less than .50 were eliminated. The reliability of the subscales was assessed by calculating Cronbach. Results Data of 102 patients was analysed. The analysis yielded six factors which were entitled \"Humiliation\", \"Physical adverse effects\", \"Separation\", \"Negative environment\", \"Fear\" and \"Coercion\". These six factors explained 54.5% of the total variance. Cronbach alpha ranged from .67 to .93, which can be interpreted as a high internal consistency. Convergent and discriminant validity yielded both highly significant results (r = .79, p < .001, resp. r = .38, p < .001). Conclusions The \"Coercion Experience Scale\" is an instrument to measure the psychological impact during psychiatric coercive interventions. Its psychometric properties showed satisfying reliability and validity. For purposes of research it can be used to compare different coercive interventions. In clinical practice it can be used as a screening instrument for patients who need support after coercive interventions to prevent consequences from traumatic experiences. Further research is needed to identify possible diagnostic, therapeutic or prognostic implications of the total score and the different subscales. Trial registration Current Controlled Trials ISRCTN70589121

Objective: To test a study design and explore the feasibility and potential effects of conventional neurological therapy, constraint induced therapy and therapeutic climbing to improve minimal to moderate arm and hand function in patients after a stroke. Method: A pilot study with six-month follow-up in patients after stroke with minimal to moderate arm and hand function admitted for inpatient rehabilitation was performed. Participants were randomly allocated to one of three treatment approaches. Main outcomes were improvement of arm and hand function and adverse effects. Results: 283 patients with stroke were screened for inclusion over a two-year period, out of which fourtyfour were included. All patients could be treated according to the protocol. Improvement of arm and hand function was significantly higher in conventional neurological therapy and constraint induced therapy compared with therapeutic climbing at discharge, and at six months follow-up (P < 0.05, effect size = 0.56–0.76). No significant differences in arm and hand function were observed between constraint induced therapy and conventional neurological therapy. Constraint induced therapy participants were significantly less at risk of developing shoulder pain at six months follow-up compared with the other participants (P < 0.05, effect size = 0.82 and 1.79, respectively). Conclusions: The study design needs adaptation to accommodate the stringent inclusion criteria leading to prolonged study duration. Constraint induced therapy seems to be the optimal approach to improve arm and hand function and minimize the risk of shoulder pain for patients with minimal to moderate arm hand function after stroke in the intermediate term.