Gait Disorder, Sarcoma, Bone, Sarcoma, Soft Tissue
Conditions
Brief 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.
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.
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.
Sponsors
St. Jude Children's Research Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait velocity (meters/second) | 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. |
Countries
United States
Contacts
CONTACTJoshua Burns, PhD
PRINCIPAL_INVESTIGATORJoshua Burns, PhD
St. Jude Children's Research Hospital
Outcome results
None listed