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NCT Number: NCT07502885

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.

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Key information

Conditions

Sarcoma, Bone Gait Disorder Mobility Limitation Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Pathological Conditions, Signs and Symptoms Sarcoma Sarcoma, Soft Tissue Signs and Symptoms

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Joshua Burns, PhD

CONTACT

[email protected]

888-226-4343

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lab based 3D Gait Assessment

Diagnostic Test

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)

Device

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

Other

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

Other

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 outcomes

  1. Gait velocity (meters/second)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1

    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.

Other outcomes

  1. Walking cadence (steps/minute)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  2. Step length with variability and asymmetry, stride length (meters)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1

    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.

  3. Six-Minute Walk Test (meters)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  4. Step width and variability (meters)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  5. Swing and stance time with asymmetry, step time with variability and asymmetry (seconds)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  6. Step velocity variability (meters/second)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  7. Gait Profile Score

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  8. Gait Deviation Index

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  9. Pelvic tilt, obliquity, and rotation angles (◦)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  10. Hip and knee flexion/extension, abduction/adduction, and rotational angles (⸰)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  11. Ankle dorsiflexion/plantarflexion, inversion/eversion,and abduction/adduction angles (⸰)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  12. Popliteal angle (⸰)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  13. Hip peak force, flexor, abductor, and extensor strength (Newtons)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  14. Knee peak force, flexor and extensor strength (Newtons)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  15. Ankle peak force, plantarflexor and dorsiflexor strength (Newtons)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  16. Quadricep lag

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  17. Hip, knee, and ankle torque (Nm/kg)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  18. Hip, knee, and ankle power (W/kg)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  19. Hip and knee flexor & extensor EMG amplitude, ankle dorsiflexor & plantarflexor EMG amplitude (µV)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  20. Pediatric Modified-Total Neuropathy Scale (ped-mTNS) (0-24 points)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  21. Bruininks Oseretsky Test of Motor Proficiency 3rd edition (BOT-3) balance subtest (standardized score)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  22. Knee Injury and Osteoarthritis Outcome Score (KOOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Ankle Foot Questionnaire for Children (0-100)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  23. PEG (ultra-brief pain measure derived from the Brief Pain Inventory) (1-10)

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

  24. PROMIS Physical Activity, Physical Function and Parent Proxy Questionnaires

    Time frame: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Burns, PhD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Mar 31, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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