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Research in rehabilitation has grown from a rare phenomenon to a mature science and clinical trials are now common. The purpose of this study is to estimate the extent to which questions posed and methods applied in clinical trials published in Clinical Rehabilitation have evolved over three decades with respect to accepted standards of scientific rigour. Studies were identified by journal, database, and hand searching for the years 1986 to 2016. A total of 390 articles whose titles suggested a clinical trial of an intervention, with or without randomization to form groups, were reviewed. Questions often still focused on methods to be used (57%) rather than what knowledge was to be gained. Less than half (43%) of the studies delineated between primary and secondary outcomes; multiple outcomes were common; and sample sizes were relatively small (mean 83, range 5 to 3312). Blinding of assessors was common (72%); blinding of study subjects was rare (19%). In less than one-third of studies was intention-to-treat analysis done correctly; power was reported in 43%. There is evidence of publication bias as 83% of studies reported either a between-group or a within-group effect. Over time, there was an increase in the use of parameter estimation rather than hypothesis testing and there was evidence that methodological rigour improved. Rehabilitation trialists are answering important questions about their interventions. Outcomes need to be more patient-centred and a measurement framework needs to be explicit. More advanced statistical methods are needed as interventions are complex. Suggestions for moving forward over the next decades are given.

Objective: To develop an adaptive measure, the Stroke Arm Ladder, to parsimoniously quantify upper extremity function post stroke. Setting: Various studies conducted in Montreal and elsewhere in Canada. Subjects: A total of 4058 persons with stroke who participated in various studies were assessed on different occasions post stroke. Assessments spanned from 3 days to 1 year post stroke. Main measures: A calibrated bank containing 49 items from tests and indices designed to assess global motor recovery of the upper extremity, upper extremity function and activities involving the upper extremity was used. Data including all testing occasions were analysed to test whether they adhered to the expectations of the Rasch partial credit model and whether item hierarchy remained stable across testing occasions. Results: Fifteen items did not meet the requirements of the Rasch model and were deleted. An adaptive measure of upper extremity function, the Stroke Arm Ladder, containing 34 items was created. The easiest item was partially executing the bilateral task of tying a scarf around one’s neck, while the hardest item was being able to transfer more than 60 blocks on the Box and Block Test. The items’ difficulty thresholds cover a wide range of difficulty levels from −7.4 to 6.2 and the global fit statistics (χ2: 331; probability: 0.18), confirmed content validity. Conclusion: The Stroke Arm Ladder demonstrates adequate initial psychometric properties. Further testing of the measure in its adaptive format is necessary before it can be used clinically.

Objective: To evaluate the efficacy of a task-oriented intervention in enhancing arm function in people with stroke. Design: Two-centre, observer-blinded, stratified, block-randomized controlled trial. Setting: General community. Patients: Ninety-one individuals within one year of a first or recurrent stroke consented to participate between May 2000 and February 2003. Interventions: The experimental intervention involved practice of functional, unilateral and bilateral tasks that were designed to improve gross and fine manual dexterity whereas the control intervention was composed of walking tasks. Members in both groups participated in three sessions a week for six weeks. Main outcome measure(s): The primary test of arm function was the Box and Block Test. Secondary tests included the Nine-Hole Peg Test, maximal grip strength, the Test d'Evaluation des Membres supé rieurs des Personnes Agées (TEMPA) and the Stroke Rehabilitation Assessment of Movement. Results: Results are for the more affected arm. Baseline performance on the Box and Block Test was an average of 26 blocks (standard deviation (SD=16) in the experimental group (n=47) and 26 blocks (Sd=18) in the control group (n=44). These values represent approximately 40% of age-predicted values. Values for the postintervention evaluation were an average of 28 (SD=17) and 28 (SD=19) blocks for the experimental and control group respectively. No meaningful change on other measures of arm function was observed. Conclusions: A task-oriented intervention did not improve voluntary movement or manual dexterity of the affected arm in people with chronic stroke.