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

NCT01565447 | Completed DMC

• 1 other identifier: OregonHSU
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Childhood Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Temporal and Spatial Gait

  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.

  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.

Study Arms (1)

Children with ALL or LL

Children diagnosed with ALL or LL will be recruited for this study

Eligibility Criteria

• Age: 2 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Age 2-27 years of age
• Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
• Currently undergoing treatment for ALL or LL or completed treatment for ALL or LL in the last 10 years.

You may not qualify if:

• Relapsed ALL or LL
• Received a stem cell transplant, either autologous or allogeneic
• Non ambulatory status prior to diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Doernbecher Children Hospital

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Susan Lindemulde, MD, MCR

  Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: March 28, 2012
• Study Start: December 1, 2011
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)