A stroke survivor who cannot lift their arm to brush their teeth or reach a cup is testing a new therapy that uses repetitive, resisted exercises—like pushing against a resistance band while reaching for a real object—to rebuild strength and control. This trial addresses a critical gap: after a stroke, standard physical therapy often relies on a therapist manually moving the patient’s limb, which may not drive the brain’s rewiring as effectively as active, goal-directed effort. The study compares this functional strength training plus conventional therapy against conventional therapy alone in 288 adults who had a stroke 14 to 60 days earlier. Researchers will also scan participants’ brains to see which neural changes—such as activity in motor areas or the integrity of white matter pathways—correlate with recovery, and whether any baseline measure predicts who will benefit most. If the therapy proves more effective, it could change how early stroke rehabilitation is delivered, shifting from passive therapist-led movements to active, patient-driven exercises that might accelerate upper limb recovery. The trial also includes a cost-effectiveness analysis to inform a future definitive study.
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HYPOTHESIS: Functional Strength Training plus conventional physical therapy (FST+CPT) enhances upper limb motor recovery early after stroke more than CPT+CPT. AIMS: to determine: the relative efficacy of FST+CPT and CPT+CPT; the neural correlates of improvement in response to FST+CPT and CPT+CPT; whether any one or combination of baseline measures predict improvement in motor function in response to FST+CPT or CPT+CPT; and estimate of cost-effectiveness to inform a subsequent definitive clinical trial. DESIGN: randomized, controlled, observer-blind, 2-group multi-centre efficacy trial with embedded explanatory measures. POPULATION: adults 14-60 days after stroke with upper limb paresis. INTERVENTIONS: protocol-driven CPT emphasises a therapist facilitating movement (therapist-dependent) whereas FST involves repetitive progressive resisted exercise during goal-directed functional activity (therapist-independent). All participants will receive the routine amount of CPT delivered by clinical therapists. Experimental FST and CPT will be delivered by different research therapists for 1.5 hours a day for 6 weeks. OUTCOMES: primary efficacy measure is change in the Action Research Arm Test (ARAT) from pre-treatment (baseline) to post-treatment (outcome). Explanatory measures include: voxel-wise estimates of brain activity during hand movement; brain white matter integrity (fractional anisotropy); and brain-muscle connectivity (e.g. latency of motor evoked potentials). ASSESSMENTS: will be conducted by an assessor blinded to group allocation at baseline, outcome and at 6 months after stroke (follow-up). SAMPLE SIZE: is based on actual ARAT data from our previous early phase trial. A sample size of 129 per group would have 80% power to detect a clinically important difference of 6 points in ARAT change using a 2-sample t-test with a 5% 2-sided significance level. Anticipating an attrition rate of 10% at outcome a total of 288 participants will be randomized. ANALYSIS: will be conducted according to the intention-to-treat principle. The primary clinical efficacy analysis will compare continuous outcome variables between treatment groups using a normal multilevel model. Therapist will be included in the model as a zero-mean random effect. Effect of treatment will be summarised using the adjusted mean difference and 95% confidence interval. To identify the neural correlates of motor improvement in both groups we will investigate associations between change from baseline in clinical outcomes and each explanatory measure. We will adjust for the variables used in randomisation. Further exploration will use multilevel linear regression. We will investigate an extension of structural mean models/causal inference as a potential exploratory analysis. To determine whether baseline measurements predict improvement in motor function we will develop a multiple regression model. Principal components analysis will be used to reduce the dimensionality of the predictor variables. ECONOMIC BENEFIT: information on costs and effects will be used to give an indication of the likely cost-effectiveness of FST+CPT. TIMETABLE/RECRUITMENT RATE We anticipate recruiting 5 participants a month a centre for 20 months. Trial set-up needs 4 months, follow-up 6 months and analysis - writeup 6 months.
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