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Psychomotor Rehabilitation for Pediatric Delirium: A Study Protocol for a Randomized Controlled Trial Investigating
Xiao Zhang1, Yu-Qian Ren2, Yi-Jun Shan2
1Department of Pediatric Rehabilitation, Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, Shanghai, 201619, People's Republic of China.
Insights
This study investigates Psychomotor Therapy (PMT) for pediatric delirium, a serious condition in critically ill children. Researchers will analyze electroencephalographic (EEG) and brain network changes to understand PMT
Area of Science:
- Pediatric critical care medicine
- Neuroscience
- Rehabilitation therapy
Background:
- Pediatric delirium is a significant complication in critically ill children, often lacking effective treatments.
- Current management strategies for pediatric delirium are limited, highlighting the need for novel therapeutic approaches.
Purpose of the Study:
- To evaluate the efficacy and safety of Psychomotor Therapy (PMT) in treating pediatric delirium.
- To characterize the underlying neurophysiological mechanisms of pediatric delirium and the effects of PMT using electroencephalography (EEG) and brain network analyses.
Main Methods:
- A single-center, assessor-blinded, randomized controlled trial involving 34 participants (22 with delirium, 12 controls).
- Participants will receive either PMT plus routine care or routine care alone for 3 days.
- Primary outcome: change in Cornell Assessment of Pediatric Delirium (CAPD) score; secondary outcomes: delirium duration, EEG parameters, PICU length of stay, and safety.
Main Results:
- This is a study protocol; data collection is ongoing from January 2023 to July 2026.
- Final results are not yet available for analysis or reporting.
Conclusions:
- The study protocol has received ethical approval from relevant hospital boards and adheres to the Declaration of Helsinki.
- Key strengths include the novel investigation of brain functional networks in pediatric delirium and the pioneering application of PMT.
- Limitations include a single-center design and geographical restrictions, suggesting the need for future multi-center studies with larger sample sizes.
Purpose:
Pediatric delirium is a serious complication in critically ill children with limited effective treatments. This study aims to evaluate the efficacy and safety of Psychomotor Therapy (PMT)-a comprehensive rehabilitation system integrating motor, cognitive, emotional, and psychological domains-in treating pediatric delirium, and to characterize its underlying mechanisms through electroencephalographic (EEG) and brain network analyses.
Patients And Methods:
This is a single-center, assessor-blinded, randomized controlled trial. A total of 34 participants (22 children with delirium aged 2 months to 14 years, meeting Richmond Agitation-Sedation Scale [RASS] and Cornell Assessment of Pediatric Delirium [CAPD] criteria, plus 6 children without any neurological disorders, managed within the same clinical environment) will be enrolled. Participants will be randomized to receive either PMT plus routine care or routine care alone. The PMT intervention will be administered once daily for 3 days. Primary outcome is the change in CAPD score. Secondary outcomes include delirium duration, EEG parameters, length of PICU stay, and safety. Assessments will be conducted at multiple time points before and after intervention.
Results:
This is a study protocol; as data collection is currently ongoing (January 2023-July 2026), final results are not yet available for analysis or reporting.
Conclusion:
The study has been approved by the ethics boards of Shanghai Yangzhi Rehabilitation Hospital and Shanghai Children's Hospital and will adhere to the Declaration of Helsinki. Findings will be disseminated via scientific conferences and publications. Key strengths include the first investigation of brain functional networks in pediatric delirium, incorporation of an environmental control group to mitigate confounding, and pioneering application of PMT. Limitations include single-center design and geographical restriction to Shanghai, necessitating future multi-center studies with larger samples.
