Deep phenotyping of walking problems after lower-limb orthopedic surgery in children treated for cancer
Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients
We will use motion-capture labs and wearable sensors to see how walking problems develop and change over time in children and teens (ages 5–20) who have lower-limb orthopedic surgery for bone or soft tissue sarcoma or steroid-induced avascular necrosis, and compare them to healthy peers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 5 Years to 20 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT07502885 on ClinicalTrials.gov |
What this trial studies
This observational study follows children and adolescents (5–20 years) who undergo lower-limb orthopedic surgery for bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis and compares them to healthy age- and sex-matched controls. Participants complete lab-based 3D motion capture, force-plate testing, muscle sensor recordings, functional tests, questionnaires, and a 7-day at-home wearable sensor monitoring period, with cases followed for up to five years. The primary outcome is walking speed measured one year after surgery, and the study will analyze personal, disease, treatment, and environmental factors linked to long-term gait deficits. Data from healthy peers will build a reference library of normal gait across ages for comparison.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 5–20 who will have lower-limb orthopedic surgery for bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis and can follow age-appropriate instructions and attend follow-up visits at St. Jude.
Not a fit: Patients with pre-existing genetic or congenital gait disorders (for example cerebral palsy), those unable to follow instructions, or those who cannot travel to St. Jude for required visits are unlikely to gain benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians predict who will have long-term walking problems and personalize rehabilitation to improve mobility and quality of life after cancer-related orthopedic surgery.
How similar studies have performed: Gait analysis and wearable monitoring have informed rehab in other orthopedic groups, but applying deep, longitudinal motion-capture specifically to pediatric cancer-related gait deficits is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Burns, PhD — St. Jude Children's Research Hospital
- Study coordinator: Joshua Burns, PhD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.