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Study protocol assesses multimodal activity intervention versus hospital-only activity on gross motor function in preschool children with cancerA Simple Play Program Could Protect Young Brains During Cancer Treatment

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Key Takeaway
Note that this study protocol outlines a trial on gross motor function in preschool children with cancer; results are pending.

The study is a protocol for a randomized controlled trial designed to evaluate the impact of a multimodal physical activity intervention on gross motor function in preschool children with cancer. The target population consists of 82 children aged 1 to 5 years who are newly diagnosed with cancer. The intervention involves supervised group-based social and physical activity at the hospital, a parent educational program, and online supervised group-based social and physical activity conducted in the families' homes. The comparator arm consists of supervised group-based social and physical activity at the hospital only.

The primary outcome is gross motor function, measured using the Peabody Developmental Motor Scales, Third Edition (PDMS-3). Secondary outcomes include parents' knowledge of physical activity and children's general physical function. Follow-up assessments are scheduled at 6 months, 9 months (primary endpoint), and 12 months after treatment initiation. The study setting encompasses both hospital and home environments.

Safety data, adverse events, serious adverse events, discontinuations, and tolerability are not reported in this protocol. Similarly, specific limitations and funding sources or conflicts of interest are not reported. The practice relevance of this protocol is to enhance clarity and transparency while providing insights for clinicians and researchers interested in the gross motor development of preschool children with cancer during treatment. Clinicians should await the final publication for definitive results.

Cancer treatment is a marathon, especially for little bodies. Preschoolers are in a critical window of rapid brain and body development. Chemotherapy and long hospital stays can hit the pause button on these natural processes.

The result can be delays in motor skills, thinking, and social growth. These areas are all tightly linked to one simple, childhood thing: play.

Current rehab often focuses on recovery after treatment ends. But what if support started the day treatment began? This study asks that vital question.

The Surprising Shift

The old way of thinking was to prioritize rest and protect children during intense treatment. Activity was often an afterthought.

But here’s the twist.

Newer thinking suggests that safe, guided physical and social activity might actually be protective. It could act as rehabilitation during the fight, not just after. This study is putting that idea to the test in a structured way for the first time with preschoolers.

How "Active Play" Becomes Medicine

Think of a child’s developing brain and body like a busy, growing city. Cancer treatment can create roadblocks and traffic jams in the neural pathways that control movement and learning.

Structured active play is like sending in a skilled traffic director. It gently encourages the brain’s "roads" to stay open and active. It signals the body to keep building strength and coordination, even under stress.

This isn’t about intense exercise. It’s about purposeful play—games that encourage reaching, balancing, throwing, and cooperating. It keeps the city functioning, even during a storm.

Researchers in Denmark will follow 82 children, aged 1 to 5, who are newly diagnosed with cancer. The trial will run for 9 months. Kids will be randomly assigned to one of two groups to see which approach works best for supporting their gross motor skills (like running and jumping).

This is a study protocol, so the results are not in yet. The trial is designed to measure the change in children’s motor skills over time.

The main comparison will happen at the 9-month mark. Scientists will use a standard play-based assessment to see if children in the more intensive play program show stronger motor development than those receiving standard care.

They will also track if parents feel more confident in keeping their children active.

But here’s the catch.

This doesn’t mean this play program is available yet. This article describes the plan for the research. The children are just beginning to enroll. We will not know the actual results until the study concludes and the data is analyzed, likely no earlier than 2026.

The study’s design reflects a significant shift in pediatric oncology rehabilitation. Experts are moving toward earlier, more integrated support. The goal is to prevent delays before they start, rather than trying to fix them later. Combining hospital sessions with guided home activities and parent education is a holistic approach that recognizes the family as the center of care.

If you are a parent of a young child with cancer, this research is a sign of hopeful progress. It is not a current treatment option. However, you can talk to your child’s care team about the importance of safe activity during treatment.

Ask about hospital play therapists, child life specialists, or physical therapists who can suggest appropriate, fun movements for your child. The core idea—that play is powerful medicine—is one you can carefully embrace now with your doctor's guidance.

This is an early-stage research plan. The sample size is modest, and the results will be specific to the program they test. As a single trial, its findings will need to be confirmed by other research teams.

The SPARK trial is now recruiting families. For the next several years, researchers will run the program, collect data, and analyze the outcomes. If the results are positive, the next step would be to implement this model in more hospitals and design larger trials. The path from research protocol to standard care is long, but it starts with studies like this one that dare to reimagine rehabilitation for the youngest and most vulnerable patients.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BackgroundPreschool children diagnosed with cancer are at risk of delays in motor, cognitive, personal, and social development, all of which are closely connected to being physically active and playing. This study protocol describes the rationale and methods for testing a multimodal intervention in a two-arm, randomized controlled superiority trial. The trial investigates the effect of a 9-month rehabilitation program incorporating physical activity at both the hospital and at home on gross motor function in preschool children diagnosed with cancer.MethodsThe Social and Physical Activity as Rehabilitation for preschool Kids with cancer (SPARK) intervention includes the following components: 1) Supervised group-based social and physical activity at the hospital; 2) A parent educational program, and 3) Online supervised group-based social and physical activity in the families’ homes. The group-based social and physical activity is conducted as structured active play. We will include 82 preschool children (aged 1–5 years), newly diagnosed with cancer, who will be randomly assigned on a 1:1 ratio to either group (a) or group (b). Group (a) will receive supervised group-based social and physical activity at the hospital (component 1), and group (b) will receive supervised group-based social and physical activity at the hospital, the parent education program, and online supervised group-based social and physical activity at home (component 1–3). The primary outcome is gross motor function measured using the Peabody Developmental Motor Scales, Third Edition (PDMS-3). Secondary outcomes are parents’ knowledge of physical activity and the children's general physical function. Assessments will be conducted at treatment initiation (baseline), and 6, 9 (primary endpoint), and 12 (follow-up) months after treatment initiation. Additionally, we will qualitatively explore the parents’ and children's experiences, the rehabilitation program's potential for the children's social development, and the importance of professionals in facilitating structured social and physical activities.DiscussionWe expect this study protocol to enhance clarity and transparency while providing insights for clinicians and researchers interested in the gross motor development of preschool children with cancer during treatment. By combining hospital-based and home-based social and physical activity with parental education, this trial has the potential to transform rehabilitation in preschoolers during cancer treatment.
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