Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07502885

Conditions

Sarcoma, Bone

Sarcoma, Soft Tissue

Gait Disorder

Eligibility Criteria

Sex: All

Age: 5 - 20

Healthy Volunteers: Accepted

Interventions

Lab based 3D Gait Assessment

Wearable Inertial Sensors (In Lab and Remote)

Functional Testing & Patient Reported Outcomes

Remote Wearable Sensor Assessment

Study Details

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.

Conditions

Sarcoma, Bone

Sarcoma, Soft Tissue

Gait Disorder

Study ID

NCT07502885

Start date

Jun 16, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2032

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 20

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

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

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.

Primary outcome measure

  • Gait velocity (meters/second) [ Time Frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1 ]

Central Contacts and Locations

Central contacts

Joshua Burns, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Joshua Burns, PhD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-18.