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NCT06737172Active, not recruiting

Functional and Structural Outcomes Following Childhood Bone or Soft Tissue Sarcomas of the Lower Extremity

Cross-sectional Analysis of Functional and Structural Outcomes in Children, Adolescents and Young Adults Within Follow-up of Bone or Soft Tissue Sarcomas of the Lower Extremity

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

Soft tissue and bone sarcomas of the lower extremity pose significant challenges for affected individuals, often associated with considerable burden. Chemotherapy, load restrictions, and surgery frequently result in long-term physical limitations, causing structural and functional deterioration. These challenges are particularly pronounced in childhood and adolescence, as they affect physiological development, resilience, and autonomy. Yet, it remains unclear whether these deficits can be fully compensated after treatment or if they result in long-term limitations, as this has not been sufficiently studied. This bicentric study includes children and adolescents undergoing follow-up care for soft tissue or bone sarcoma of the lower extremity within 1 to 5 years since end of therapy. The cohort did not receive any specific prehabilitative training during neoadjuvant therapy. Participants will be divided into two subgroups based on the study site: (1) participants who participated in a non-specific exercise program during acute therapy and (2) participants who did not receive any exercise promotion during acute therapy. Target sample size is n=16. The study has been consented by the local ethics committee. Several structural and functional parameters are measured to document the natural status of muscular structures and functional abilities after the treatment of a solid tumor in the lower extremities, with a focus on identifying specific deficits and the associated long-term limitations in daily life. The measurements include psoas muscle area, body composition, strength, mobility, balance ability, gait analysis, two questionnaires on physical activity and quality of life, and quantitative measures of the clinical course during acute treatment (days of hospitalization, infection rates, etc.). For children and adolescents, daily functionality and the experience of autonomy are crucial for physiological development and contribute significantly to quality of life. Therefore, these factors should be investigated and supported in this cohort, a group that is currently underrepresented in scientific research.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
18 (estimated)
First submitted
25 Nov 2024
Start date
1 Apr 2025
Primary completion date
31 Oct 2026
Lead sponsor
Technical University of Munich
NCT number
NCT06737172

What you commit to

  • Study type: Observational
  • Planned participants: 18
  • From 1 Apr 2025 to the primary completion date, 31 Oct 2026
  • 2 sites 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 illness

  • Cognitive impairment or developmental delay that hinders comprehension of the instructions in the testing situation, thereby preventing standardized diagnostic data collection

Lab values

  • Medical contraindications for testing (e.g. injury, pain, dizziness, lack of orthopedic clearance for weight-bearing in the tumor region, other acute orthopedic limitations unrelated to the underlying condition, etc.)

Other

  • Language barriers that prevent understanding of the instructions for study participation

Who the study is looking for

  • Cessation of treatment for a bone tumor or soft tissue sarcoma of the lower extremity 1-5 years ago
  • Age Range of 6 to 18 years
  • Treatment has been conducted at one of the two designated study sites

Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. von Haunersches Kinderspital, University of Munich
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Technical University of Munich, Germany; TUM School of Medicine and Health, Department of Pediatrics. German Center for Child and Adolescent Health (DZKJ), partner site Munich
Coordinator of this site? Confirm its status
MunichGermanyUnknown status

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