Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma, Soft Tissue; Gait Disorder; Sarcoma, Bone
• Intervention / Treatment: Diagnostic test: Lab based 3D Gait Assessment; Device: Wearable Inertial Sensors (In Lab and Remote); Other: Functional Testing & Patient Reported Outcomes; Other: Remote Wearable Sensor Assessment

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Joshua Burns, PhD; Phone Number: 888-226-4343; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Joshua Burns, PhD; Phone Number: 888-226-4343; Email: referralinfo@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Lab based 3D Gait Assessment; 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.; Device: Wearable Inertial Sensors (In Lab and Remote); 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.; Other: Functional Testing & Patient Reported Outcomes; 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; Other: Remote Wearable Sensor Assessment; 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.
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.	Diagnostic test: Lab based 3D Gait Assessment; 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.; Device: Wearable Inertial Sensors (In Lab and Remote); 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.; Other: Functional Testing & Patient Reported Outcomes; 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; Other: Remote Wearable Sensor Assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking cadence (steps/minute)	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.
Step length with variability and asymmetry, stride length (meters)	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
Six-Minute Walk Test (meters)	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.
Step width and variability (meters)	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.
Swing and stance time with asymmetry, step time with variability and asymmetry (seconds)	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.
Step velocity variability (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.
Gait Profile Score	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.
Gait Deviation Index	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.
Pelvic tilt, obliquity, and rotation angles (◦)	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.
Hip and knee flexion/extension, abduction/adduction, and rotational angles (⸰)	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.
Ankle dorsiflexion/plantarflexion, inversion/eversion,and abduction/adduction angles (⸰)	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.
Popliteal angle (⸰)	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.
Hip peak force, flexor, abductor, and extensor strength (Newtons)	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.
Knee peak force, flexor and extensor strength (Newtons)	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.
Ankle peak force, plantarflexor and dorsiflexor strength (Newtons)	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.
Quadricep lag	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.
Hip, knee, and ankle torque (Nm/kg)	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.
Hip, knee, and ankle power (W/kg)	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.
Hip and knee flexor & extensor EMG amplitude, ankle dorsiflexor & plantarflexor EMG amplitude (µV)	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.
Pediatric Modified-Total Neuropathy Scale (ped-mTNS) (0-24 points)	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.
Bruininks Oseretsky Test of Motor Proficiency 3rd edition (BOT-3) balance subtest (standardized score)	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Ankle Foot Questionnaire for Children (0-100)	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.
PEG (ultra-brief pain measure derived from the Brief Pain Inventory) (1-10)	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.
PROMIS Physical Activity, Physical Function and Parent Proxy Questionnaires	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.

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Joshua Burns, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcoma; Mobility Limitation; Osteosarcoma; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Care Economics and Organizations; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Surveys and Questionnaires; Health Planning; Health Care Surveys; Health Services Research; Patient Outcome Assessment; Patient Reported Outcome Measures
• Other Study ID Numbers: DEEPGAIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be made available at the time of article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No