ClinicalTrials.gg
RecruitingNCT07502885Updated Jun 18, 2026

Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients

An observational study in Sarcoma, Bone, Sarcoma, Soft Tissue and Gait Disorder, sponsored by St. Jude Children's Research Hospital. Recruiting at 1 site in United States. Open to participants aged 5 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by St. Jude Children's Research Hospital · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
5 Years to 20 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Osteosarcoma by St. Jude Children's Research Hospital — 7 open to participants now, 8 under way, none of them phase 3. Osteosarcoma · St. Jude Children's Research Hospital.

Started
2026
with 2 others
Observational
4 of 19
2 open now
Registered
18th of 19
by date

Among the 19 studies in Osteosarcoma by St. Jude Children's Research Hospital, this one is one of 3 that started in 2026, is one of 4 observational ones, and was the 18th registered.

By phase

19 studies; the count open now beside each. This study's row is marked.

Phase 25 · 1 open
Observationalthis study4 · 2 open
Phase 14 · 1 open
No phase3 · 1 open
Phase 1/23 · 2 open

By the year they started

First in 1999; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 50 across the 15 interventional studies, 188 across the 4 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 19 studies in Osteosarcoma by St. Jude Children's Research Hospital, or all of them as a file.
02

Study 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.
Read the 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.

03

Conditions studied

  • Sarcoma, Bone
  • Sarcoma, Soft Tissue
  • Gait Disorder
04

Who can participate

Ages eligible
5 Years to 20 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Cases:

  • Participant requiring orthopedic surgery due to a diagnosis of lower limb bone sarcoma, soft tissue sarcoma, or -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

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 .
  • 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 ( >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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · Device: Wearable Inertial Sensors (In Lab and Remote) · Other: Functional Testing & Patient Reported Outcomes · Other: Remote Wearable Sensor Assessment

  • 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 · Device: Wearable Inertial Sensors (In Lab and Remote) · Other: Functional Testing & Patient Reported Outcomes · Other: Remote Wearable Sensor Assessment

Interventions

  • Diagnostic testLab 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.

  • DeviceWearable 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.

  • OtherFunctional 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

  • OtherRemote 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.

06

What researchers measure

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.

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

Other outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

  14. 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.

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

  15. 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.

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

  16. 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.

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

  17. 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.

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

  18. 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.

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

  19. 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.

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

  20. 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.

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

  21. 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.

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

    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.

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

  23. 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.

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

  24. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jan 2031, 55 months after the start.

Of 41 observational studies under Osteosarcoma, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 228. This study's planned 55 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Mar 31, 2026
StartActual
Jun 16, 2026
Primary completionEst.
Jan 2031
CompletionEst.
Jan 2032
Last update
Jun 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07502885
Responsible party
Sponsor
First posted
Mar 31, 2026
Start date
Jun 16, 2026
Primary completion
Jan 2031 (estimated)
Completion
Jan 2032 (estimated)
Last update
Jun 18, 2026

Study contacts

Joshua Burns, PhD
Contact
referralinfo@stjude.org
888-226-4343
Joshua Burns, PhD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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