Feasibility, Safety, and Tolerability of Remote Ischemic Conditioning in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial
Abstract
Highlights What are the main findings? Remote ischemic conditioning (RIC) was feasible in children with unilateral cerebral palsy (CP), with excellent recruitment, retention, and full adherence to the intervention protocol. Across more than 300 conditioning sessions, RIC was safe and well tolerated, with stable cardiopulmonary parameters and only minor, transient adverse events. What is the implication of the main finding? RIC can be delivered reliably and safely in pediatric neurorehabilitation research, supporting its use in future large-scale clinical trials. These findings establish the groundwork for testing RIC as a novel priming strategy to augment neuroplasticity and functional recovery in children with CP. Abstract Background: Remote ischemic conditioning (RIC) has shown promise as a neuroprotective strategy, but its application in children with cerebral palsy (CP) remains unexplored. We conducted a randomized controlled trial to evaluate the feasibility, safety, and tolerability of repeated, 6–7 sessions of RIC in children with unilateral CP. Methods: Fifty-one children aged 6–16 years with unilateral CP were randomized (1:1) to receive RIC or sham conditioning on the more affected arm. Primary feasibility outcomes included recruitment metrics, intervention adherence, retention, and protocol fidelity. Safety endpoints included continuous monitoring of oxygen saturation, blood pressure, heart rate, and adverse event incidence. Tolerability was assessed via…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 148 participants or records.
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