Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-20
SponsorSt. Jude Children's Research Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lab based 3D Gait Assessment
- Wearable Inertial Sensors (In Lab and Remote)
- Functional Testing & Patient Reported Outcomes
- Remote Wearable Sensor Assessment
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov