The goal of DEEPGAIT study is to determine how serious walking problems are for pediatric cancer patients who have had orthopedic surgery, how they change over time, and what can be done to help. Healthy participants without cancer will also be included in this study in order to better understand the difference in walking problems between the 2 groups.

DEEPGAIT is a long term study that uses advanced tools-including 3D motion capture, muscle sensors, force plates, and wearable devices-to take a detailed look at how these patients move. Their results are compared to healthy children of the same age and sex.

PRIMARY OBJECTIVES

• Characterize gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis.
• Identify personal, disease, treatment and environment risk factors for gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis.

SECONDARY OBJECTIVES

• Build a library of broadly representative normative reference values to generate age- and sex-matched z-scores to quantify frequency, severity and progression of gait deficits among pediatric cancer patients in relation to healthy controls.
• Characterize the changes of gait parameters in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.
• Identify personal, disease, treatment and environment risk factors for trajectories of gait deficits in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.

The DEEPGAIT study aims to understand how walking ability changes before and after lower limb surgery by using 3D motion capture technology, wearable sensors, movement testing, and surveys. The study will also compare patients' walking patterns to healthy children and teens to create a reference library of normal gait across age groups.

Children ages 5-20 years who need surgery for bone sarcoma, soft tissue sarcoma, or steroid induced AVN will take part in several assessments over five years. Healthy peers ages 5-20 years will participate once. All participants will complete lab based walking tests, functional assessments, questionnaires, and a 7 day at home wearable sensor study.

The main goal is to measure walking speed one year after surgery and identify factors that influence long term mobility, recovery, and quality of life. The results may help doctors improve rehabilitation and better support young people recovering from cancer related orthopedic conditions.

Inclusion Criteria

Cases:

• Participant requiring orthopedic surgery due to a diagnosis of lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis (Appendix III) and will receive further additional treatment and/or follow-up care at St. Jude.
• Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment.

Controls:

• Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment.
• Participant (or their parent/legal guardian) considers themself healthy for their age.
• Participant (or their parent/legal guardian) reports being able to participate in normal daily activities of life with respect to their age.

Exclusion Criteria

Cases:

• Individuals with pre-existing genetic/congenital disorders affecting gait will be excluded e.g., cerebral palsy.
• Individuals who are unable to follow age-appropriate instructions during the gait assessment.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Individuals diagnosed with radiation-induced avascular necrosis.

Controls:

• Individuals who are unable to follow age-appropriate instructions during the gait assessment.
• Individuals who self-report health conditions affecting gait and mobility.
• Individuals who have the following conditions: diabetes mellitus due to impaired circulation, sensation and strength, malignant cancers, demyelinating inflammatory and degenerative neurological conditions, pregnancy, obesity (BMI >40 kg/m2), severe cardiac or pulmonary disease affecting performance of daily activities, history of major surgery affecting gait and mobility, infections or inflammatory arthropathies, severe mobility impairment necessitating dependence on mobility aids for all ambulation.
• Individual or legal guardian/representative is unable or unwilling to give written informed consent.

This study includes children, teens, and young adults ages 5-20 who receive care at St. Jude and need lower limb orthopedic surgery for bone sarcoma, soft tissue sarcoma, or steroid induced avascular necrosis. These participants will complete walking and movement assessments before surgery and again at several timepoints afterward. The study will include healthy volunteers ages 5-20, mainly friends or siblings of patients, who do not have conditions that affect walking. Healthy participants complete a single visit to provide comparison data. In total, the study will include 150 pediatric cancer patients and 150 healthy controls to help researchers better understand walking patterns and recovery after surgery.

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Data will be made available at the time of article publication.

Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.