Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
Study Completion
Last participant's last visit for all outcomes
January 1, 2032
June 4, 2026
June 1, 2026
4.5 years
March 5, 2026
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Gait velocity (meters/second)
Descriptive statistics will be reported for case participants, both longitudinally and in comparison with controls, at baseline, 1, 2, and 5 years post-surgery. Descriptive statistics will be reported for controls at Day 1.
Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1
Other Outcomes (24)
Walking cadence (steps/minute)
Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.
Step length with variability and asymmetry, stride length (meters)
Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1
Six-Minute Walk Test (meters)
Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.
- +21 more other outcomes
Study Arms (2)
Pediatric Cancer Surgery Cohort (Cases)
This group includes children and teens (ages 5-20 years) who need surgery on a leg joint or bone because of a cancer related condition. They take part in the study several times: before surgery, and then 1, 2, and 5 years after surgery. They also do a week of at home monitoring after the 1 year visit.
Healthy Control Cohort
This group includes healthy children and teens (ages 5-20 years) who are matched by age and sex to participants in the surgery group. They take part in the study once, around the same time the surgery participant reaches their 1 year visit.
Interventions
Marker based motion capture, surface EMG, instrumented force plates, spatiotemporal analysis, and 10 meter walking trials conducted barefoot and with shoes (or prosthesis/assistive devices if applicable). Captures walking speed (primary outcome), joint kinematics, kinetics, EMG activity, and detailed gait parameters.
Sensors placed bilaterally on the midfoot and lower leg, plus a wrist sensor. Capture gait velocity, spatiotemporal metrics, and 3D ankle kinematics during lab assessments and during a 7 day post T1 monitoring period in real world settings. Data processed using accelerometer, gyroscope, and magnetometer fusion.
Comprehensive functional evaluation including: * Anthropometrics and alignment * Strength testing (hand held dynamometry) * Joint range of motion * Balance (BOT 3) * Endurance (6 minute walk test) * Peripheral sensorimotor integrity (Ped mTNS) * Patient reported outcomes: KOOS, HOOS, PEG, Oxford Ankle Foot Questionnaire for Children, PROMIS Physical Activity/Function/Parent Proxy
Seven day at home/in community gait monitoring after the T1 visit. Participants wear midfoot, lower leg, and wrist sensors daily, complete a 5 minute structured indoor walking task each day, and record adherence, tolerability, fatigue, and satisfaction in an online study diary. Training video and tablet provided.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Burns, PhD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 31, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
January 1, 2032
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- 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.
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.