Trial reportBMC neurology2026
Preliminary effects of intermittent theta burst stimulation combined with virtual reality-based cycling training on upper extremity function in children with cerebral palsy: a double-blind randomized crossover trial.
Trial report in BMC neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04101994 (Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by Noninvasive Brain Stimulation in Patients With Cerebral Palsy), which is not on this map. Not yet cited in PubMed.
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Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by Noninvasive Brain Stimulation in Patients With Cerebral Palsy
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9 authors.
Funding
Abstract
backgroundCerebral palsy is a permanent disorder that affects motor and posture control, significantly impacting the motor function, daily activities, and participation of affected individuals. Virtual reality-based training and repetitive transcranial magnetic stimulation have each demonstrated benefits for cerebral palsy rehabilitation, but their combined effects remain largely unexplored. This randomized controlled crossover trial examined the potential effects of intermittent theta burst stimulation, a patterned form of repetitive transcranial magnetic stimulation, on virtual reality-based cycling training designed to improve upper extremity function in children with spastic cerebral palsy.
methodsTwelve participants were enrolled and randomized, with eight completing two sequential intervention phases in a counterbalanced order: real stimulation combined with virtual cycling training (n = 10 conditions) and sham stimulation combined with virtual cycling training (n = 10 conditions). The virtual cycling training program included twelve sixty-minute sessions delivered two to three times per week, and stimulation focused on the hand motor region of the involved hemisphere. The outcome measures included the Box and Block Test, the Bruininks-Oseretsky Test of Motor Proficiency, Pediatric Motor Activity Log, Caregiver Functional Use Survey, and Goal Attainment Scales to assess manual dexterity, activity performance, caregiver-reported functional use, and personalized goal attainment, both before and after the intervention.
resultsLinear mixed-effects models revealed a significant treatment effect for Goal Attainment Scales scores only (F = 7.474, p = 0.019), with intermittent theta burst stimulation yielding superior results. No significant period, sequence or treatment effects were observed for other outcomes. Between-condition comparisons confirmed a significant difference in Goal Attainment Scales scores (mean difference = 12.63, 95% CI [3.26, 22.08], p < 0.05, Cohen's d = 1.30), while all other measures showed non-significant differences with small effect sizes.
conclusionsThese preliminary findings suggest that a combination of intermittent theta burst stimulation and virtual reality-based cycling training may modestly improve goal-directed upper-extremity function in children with spastic cerebral palsy. However, given the exploratory design and limited sample size, larger studies are required to confirm these findings and establish clinical efficacy.
trial registrationThis trial was registered at ClinicalTrials.gov (NCT04101994) on 22 September 2019. Participant recruitment began on 29 March 2019. Retrospectively registered.
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