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Temporal and Spatial Gait Parameters of Children Undergoing Treatment for and Surviving Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma


N/A
2 Years
27 Years
Open (Enrolling by invite only)
Both
Acute Lymphoblastic Leukemia, Childhood Lymphoblastic Lymphoma

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Trial Information

Temporal and Spatial Gait Parameters of Children Undergoing Treatment for and Surviving Acute Lymphoblastic Leukemia and 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 PedsQLâ„¢ 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


Inclusion Criteria:



1. Age 2-27 years of age

2. Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma

3. Currently undergoing treatment for ALL or LL or completed treatment for ALL or LL in
the last 10 years.

Exclusion Criteria

1. Relapsed ALL or LL

2. Received a stem cell transplant, either autologous or allogeneic

3. Non ambulatory status prior to diagnosis of acute lymphoblastic leukemia or
lymphoblastic lymphoma

Type of Study:

Observational

Study Design:

Time Perspective: Cross-Sectional

Principal Investigator

Susan Lindemulde, MD, MCR

Investigator Role:

Study Director

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

OregonHSU

NCT ID:

NCT01565447

Start Date:

December 2011

Completion Date:

March 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Childhood Lymphoblastic Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Doernbecher Children HospitalPortland, Oregon  97239