Sarcoma, BoneNCT07502885
Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients
An observational study of Sarcoma, Bone and Sarcoma, Soft Tissue, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoma, Bone, Sarcoma, Soft Tissue, Gait Disorder
- What is being tested?
- Lab based 3D Gait Assessment, Wearable Inertial Sensors (In Lab and Remote) and Functional Testing & Patient Reported Outcomes
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2026to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Joshua Burns, PhD, 888-226-4343, referralinfo@stjude.org
About this study
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.
Read more
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.
- Conditions
- Sarcoma, Bone, Sarcoma, Soft Tissue, Gait Disorder
- Being tested
- Lab based 3D Gait Assessment, Wearable Inertial Sensors (In Lab and Remote), Functional Testing & Patient Reported Outcomes, Remote Wearable Sensor Assessment
- Medical subject headings
- Osteosarcoma, Sarcoma, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab based 3D Gait AssessmentDiagnostic 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 OutcomesOther
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 AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Case participants: Baseline/study entry, 1, 2, and 5 years post-surgery. Control participants: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start16 Jun 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, BoneStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Burns, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502885
- Sponsor's protocol ID
- DEEPGAIT
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT07502885
- Acronym / sponsor ID
- DEEPGAIT
- Conditions
- Sarcoma, Bone, Sarcoma, Soft Tissue, Gait Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Cancer Surgery Cohort (Cases) | – | 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 AssessmentThis 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 | – | 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 AssessmentThis 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. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
- Individuals who are unable to follow age-appropriate instructions during the gait assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab based 3D Gait AssessmentMarker 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. | Diagnostic test | Healthy Control Cohort, Pediatric Cancer Surgery Cohort (Cases) |
| 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. | Device | Healthy Control Cohort, Pediatric Cancer Surgery Cohort (Cases) |
| Functional Testing & Patient Reported OutcomesComprehensive 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 | Healthy Control Cohort, Pediatric Cancer Surgery Cohort (Cases) |
| Remote Wearable Sensor AssessmentSeven 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. | Other | Healthy Control Cohort, Pediatric Cancer Surgery Cohort (Cases) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Burns, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, Bone and Sarcoma, Soft Tissue, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Burns, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.