Trial document




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  DRKS00010406

Trial Description

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Title

Specific impairments in the functional performance of the lower extremities and thus related parameters in pediatric cancer patients

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Trial Acronym

Functional performance in pediatric cancer patients

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Many childhood cancer patients suffer functional limitations in the lower extremity as side or late effects of cancer and its medical treatment. These limitations may lead to restrictions gait, mobility, and activity levels. However, most research results in pediatric oncology are based on trials with patients with acute lymphoblastic leukemia (ALL) as well as on patients who had received vincristine. To investigate whether functional limitations occur in childhood cancer survivors in general, the present study analyzes potential deficiencies in the functional performance of the lower extremity and other related parameters in a group of children with mixed cancer diagnoses (patient group) in comparison to a group of age- and gender-matched healthy peers (comparison group). Therefore, isometric strength of ankle dorsiflexion and knee extension (dynamometer), ankle dorsiflexion range of motion (goniometer) and functional strength of lower extremity (standing long jump) are measured once. In addition, functional mobility (timed-up-and-go-test), gait performance (10meter-walking test, 2minutes-walking test), walk-to-run-transition-time (treadmill test) as well as physical activity behavior (physical activity questionnaire) are analyzed.

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Brief Summary in Scientific Language

Many childhood cancer patients suffer functional limitations in the lower extremity as side or late effects of cancer and its medical treatment. These limitations may lead to restrictions gait, mobility, and activity levels. However, most research results in pediatric oncology are based on trials with ALL-patients as well as on patients who had received vincristine. To investigate whether functional limitations occur in childhood cancer survivors in general, the present study analyzes potential deficiencies in the functional performance of the lower extremity and thus related parameters in a group of children with mixed cancer diagnoses (patient group) in comparison to a group of age- and gender-matched healthy peers (comparison group). Therefore, isometric strength of ankle dorsiflexion and knee extension (dynamometer), ankle dorsiflexion range of motion (goniometer) and functional strength of lower extremity (standing long jump) are measured once. In addition, functional mobility (timed-up-and-go-test), gait performance (10meter-walking test, 2minutes-walking test), walk-to-run-transition-time (treadmill test) as well as physical activity behavior (physical activity questionnaire) are analyzed.

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Organizational Data

  •   DRKS00010406
  •   2016/04/25
  •   [---]*
  •   yes
  •   Approved
  •   032/2016, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   pediatric cancer
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Interventions/Observational Groups

  •   Patient group includes pediatric cancer patients (4-20 years) after cessation of inpatient medical treatment (maximum 3 years) that take part in the following measurement: isometric strength of ankle dorsiflexion and knee extension, ankle dorsiflexion range of motion , functional strength of lower extremity, functional mobility, gait performance, walk-to-run-transition-time, physical activity behavior.
  •   Comparison group includes age- and gender-matched healthy children that take part in the following measurement: isometric strength of ankle dorsiflexion and knee extension, ankle dorsiflexion range of motion , functional strength of lower extremity, functional mobility, gait performance, walk-to-run-transition-time, physical activity behavior.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Isomentric trength of ankle dorsiflexion is measured once (dynamometer).

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Secondary Outcome

Ankle dorsiflexion range of motion (goniometer), isometric strength of knee extension (dynamometer), and functional strength of lower extremity (standing long jump) are measured once. In addition, functional mobility (timed-up-and-go-test), gait performance (10meter-walking test, 2minutes-walking test), walk-to-run-transition-time (treadmill test) as well as physical activity behavior (physical activity questionnaire) are measured once.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/04/04
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Years
  •   20   Years
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Additional Inclusion Criteria

patient group:
• Age: ≥ 4 und ≤ 20 years
• pediatric cancer disease
• completion off all inpatient medical treatment
• cessation of inpatient medical treatment within the last 3 years
• medical clearance (approval of the treating physician)
• written informed consent from the legal guardian


Comparison group:
• matched pair (age and gender) to one of the patients in the patient group (age ± 1 year)
• written informed consent from the legal guardian

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Exclusion Criteria

Patient group:
• specific stress conditions (according to the
physician’s advice)
• specific physiological impairments that would make participation in functional motor testing not possible (according to the physician’s advice)
• specific psychological impairments that would make participation in functional motor testing not possible (according to the physician’s advice)

Comparison group:
• known oncological or chronic disease
• specific stress conditions (according to the
physician’s advice)
• specific physiological impairments that would make participation in functional motor testing not possible (according to the physician’s advice)
• specific psychological impairments that would make participation in functional motor testing not possible (according to the physician’s advice)

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Addresses

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    • Deutsche Sporthochschule Köln, Insstitut für Kreislaufforschung und Sportmedizin
    • Mr.  PD Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Insstitut für Kreislaufforschung und Sportmedizin
    • Mr.  PD Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin
    • Ms.  Vanessa  Oschwald 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln, Insstitut für Kreislaufforschung und Sportmedizin
    • Mr.  PD Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/29
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Trial Publications, Results and other Documents

  •   Oschwald V, Prokop A, Boehme J, Gressler N, Harscheidt F, Maas V, Bloch W, Baumann FT, Däggelmann J. Limited Walking Abilities and Impaired Ankle Dorsiflexion Function in Children After Intense Cancer Treatment. Klinische Pädiatrie 2018. doi: 10.1055/a-0804-1899
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* This entry means the parameter is not applicable or has not been set.