Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01565447 |
| Other study ID # |
OregonHSU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2011 |
| Est. completion date |
March 20, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This purpose of this study it to characterize the walking patterns of children diagnosed with
Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the
treatment protocol and after completion of treatment. Their walking patterns will be compared
to children without ALL or LL to see if their walking patterns are different at specific
times in their treatment program or up to 10 years after completion of their treatment. The
investigators will gather data by observing how the child walks, runs, hops on one foot and
climbs stairs and by recording walking patterns on a pressure sensitive mat. The
investigators will compare this data to children without ALL and LL.
Description:
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
