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Enrolling by invitation

NCT Number: NCT05235633

ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma

Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. This associated investigation to the study with the ClinicalTrials.gov Identifier NCT03934060 aims at collecting data in a comparison cohort with respect to ADLs in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.

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Key information

Conditions

Childhood Cancer Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany

Munich, 80804, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents aged 4-18 years
  • At the end of acute treament for leukemia or non-Hodgkin lymphoma
  • Diagnosed and/or treated at the Dr. von Hauner Children's Hospital, University of Munich
  • Informed consent as documented by signature

Exclusion criteria

  • Medical contraindication to perform this unique test battery (e.g., acute bleeding risk, pain, nausea, acute orthopedic impairments)
  • Inability to follow study procedures (e.g., language problems, mental retardation)

Treatment and study plan

Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment

Diagnostic Test

Participants perform a test battery to assess the capability to accomplish Activities of Daily Living that includes a standardized and validated questionnaire, a parcour with tasks based on Activities of Daily Living and a motor performance test.

Primary outcomes

  1. Score of the Activities Scale for Kids - performance version

    Time frame: During the procedure

    The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions and the current status of accomplishment of activities of daily living. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer).

Secondary outcomes

  1. Motor Performance

    Time frame: During the procedure

    Motor performance is assessed by the MOON-test (Motor performance test in Pediatiric Oncology), a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children.

  2. Performance in a Parkour in Activities of Daily Living

    Time frame: During the procedure

    A standardized parkour with tasks imitating activities of daily living is used to objectively verify the ASK score. Points from 0-4 are counted for each task depending on quality of movement (0 = task can not be completed, 1 = task can be completed with help, 2 = task can be completed with several attempts, 3 = task can be completed with only little effort, 4 = task can be completed without any problems or effort). There are no reference values for the parkour, but intra-individual changes are analyzed.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

Activities of Daily Living at the End of Acute Treatment for Acute Leukemia or Non-Hodgkin Lymphona During Childhood and Adolescence

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2022
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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