Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients

Conditions

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

Eligibility Criteria

Sex

ALL

Age

5 Years - 20 Years

Healthy Volunteers

Accepted

Interventions

• Lab based 3D Gait Assessment — DIAGNOSTIC_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 Outcomes — OTHER
  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 Assessment — OTHER
  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 Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Jan 31, 2031

Completion

Jan 31, 2032

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

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 ]

Central Contacts

• Joshua Burns, PhD
  888-226-4343
  [email protected]

Locations (1)

Find similar trials in Memphis, TN

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