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NCT04672681Active, not recruiting

Rehabilitation Including Structured Active Play for Preschoolers With Cancer.

Source: ClinicalTrials.gov · Last updated 8 Jun 2025

Brief summary (registry, in English)

Treatment for childhood cancer causes treatment-related acute adverse events such as muscle weakness and physical incompetence. With long admissions, isolation, and long-term bed rest, this means reduced physical activity and, ultimately, gross motor functioning development is affected. Furthermore, the children participate less in sport and leisure activities, inhibiting social skills, and the children feel isolated from peers. The above makes it difficult for children to return to everyday activities. Physical activity in the form of play and movement activities is essential for preschool children's gross motor, social, and personal development- a development where parents play a crucial role. Replay is a randomized controlled trial that will include 84 children with cancer aged 1-5 years at the University Hospital Copenhagen, Rigshospitalet. The children are included at the treatment initiation and are randomized to either the intervention group or the control group. The intervention consists of six months of daily structured play-based physical activity, including daily parent administered play and movement and three weekly group-based play and movement sessions at the hospital during admissions. Gross motor and physical function is measured with 1) Peabody Developmental Motor Scales, Second Edition (PDMS-2), Pediatric Evaluation of Disability Inventory (PEDI), Handgrip strength, and a six-minute walk test. The assessment time points are baseline (initiated timepoint), 3- and 6 months (endpoint) after initiated treatment. The intervention group will be observed and invited to participate in qualitative interviews. The control group will receive usual care and specific physiotherapy if needed.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
84 (actual)
First submitted
3 Dec 2020
Start date
7 Jan 2021
Primary completion date
30 Dec 2026
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
NCT number
NCT04672681

What you commit to

  • Study type: Interventional
  • Participants enrolled: 84
  • From 7 Jan 2021 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Children with mental disabilities that complicates the ability to follow instructions.

Who the study is looking for

  • Children diagnosed with cancer or benign disorders and are being treated with chemotherapy and/or radiation and are admitted to the Department of Pediatric Hematology/Oncology at University Hospital Copenhagen, Rigshospitalet.
  • Children at the age of 1-5,9 years at diagnosis.
  • Children whose parents can communicate in Danish.

Age in the registry: 12 months to 5 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.