Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma Gait Parameters Study
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|ClinicalTrials.gov Identifier: NCT01565447|
Recruitment Status : Active, not recruiting
First Posted : March 28, 2012
Last Update Posted : September 10, 2019
|Condition or disease|
|Acute Lymphoblastic Leukemia Childhood Lymphoblastic Lymphoma|
Cases will be identified and referred by the primary oncologist or by the Childhood Cancer Survivorship team. When a possible subject has been identified they will be contacted via telephone or during a routine clinic visit to determine their interest in the study. Two hundred subjects will be recruited for participation with the goal of 5-10 subjects at each of the 14 times points across the treatment protocol and survivorship. These time points to include: at diagnosis, the start of consolidation therapy, the start of interim maintenance therapy, the start of delayed intensification therapy, Day 29 of delayed intensification therapy, the start of interim maintenance II therapy (if applicable), Day 1 of cycle 1,3,5 of maintenance therapy, end of therapy, and 1, 3, 5, and 10 years off therapy ( +/-1 year).
Clinical data will be collected from the medical record, roadmaps documenting cancer-directed therapy, direct patient interview and examination by the physical therapist during the study evaluation. Clinical data will include: Date of birth (to calculate age at diagnosis and current age); Gender; Race and Ethnicity; Primary cancer diagnosis; Date of Primary Cancer Diagnosis; Chemotherapeutic agents received (agent name, cumulative dose and date received); Radiation therapy (date received, site radiated, and dose delivered); Any other clinical conditions affecting musculoskeletal performance; Dates of previous PT; Pain score at the time of study participation. Height, weight, shoe size and leg length will be collected at time of study participation.
Subjects will complete a self report of the PedsQL™ Generic Core Scale and the parents will complete the parental report.
Observation gait assessment will include hopping on one foot, running and walking 30' and ascending/descending stairs.
Temporal spatial gait parameters will be recorded on the GaitRite mat
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Temporal and Spatial Gait Parameters of Children Undergoing Treatment for and Surviving Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Children with ALL or LL
Children diagnosed with ALL or LL will be recruited for this study
- Temporal and Spatial Gait [ Time Frame: At diagnosis, start of consolidation tx, the start of interim maintenance tx, the start of delayed intensification tx, Day 29 of delayed intensification tx, the start of interim maintenance II tx (if applicable), Day 1 of cycle, 1,3,5 of maintenance tx. ]To characterize temporal and spatial gait parameters of children with ALL/LL at specific time points during their treatment and survivorship using the GAITRite® evaluation system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565447
|United States, Oregon|
|Doernbecher Children Hospital|
|Portland, Oregon, United States, 97239|
|Study Director:||Susan Lindemulde, MD, MCR||Oregon Health and Science University|