Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma Gait Parameters Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Nancy Durben, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01565447
First received: January 31, 2012
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition
Acute Lymphoblastic Leukemia
Childhood Lymphoblastic Lymphoma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Temporal and Spatial Gait Parameters of Children Undergoing Treatment for and Surviving Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Secondary Outcome Measures:
  • Pediatric Quality of Life Questionnaire [ Time Frame: At one of the 10 specific time points in therapy or at years 1,3,5 and 10 years off therapy (+/- 1 year) ] [ Designated as safety issue: No ]
    A 23 question questionnaire addressing concerns in the area of physical activity, feelings, getting along with others and problems with work or studies.

  • Global Gait Score [ Time Frame: At one of the 10 specific time points in therapy or at years 1,3,5 and 10 years off therapy (+/- 1 year) ] [ Designated as safety issue: No ]
    Childrens' ability to walk, run, hop on one leg, climb stairs will be observed and scored based on a 0-4 scale. O will indicate one skill that is not normal, a 2 will indicate 2 skills, 3 will indicate 3 skills and a 4 will indicate 4 skills that are not normal


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children with ALL or LL
Children diagnosed with ALL or LL will be recruited for this study

Detailed 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

  Eligibility

Ages Eligible for Study:   2 Years to 27 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children diagnosed with ALL or LL and are currently undergoing treatment for or have survived treatment and are no more than 10 years post completion of treatment

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565447

Locations
United States, Oregon
Doernbecher Children Hospital
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Study Director: Susan Lindemulde, MD, MCR Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Nancy Durben, Assistant Professor of Physical Therapy, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01565447     History of Changes
Other Study ID Numbers: OregonHSU
Study First Received: January 31, 2012
Last Updated: March 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014