No phaseRecruiting

Safety, Effectiveness, and Reimbursement-Based Value of ERAS-Linked Wearable Robot-Assisted Early Gait Rehabilitation After Knee and Hip Arthroplasty: A Multicenter Real-World Study

Sponsor
Seoul National University Bundang Hospital
Enrolment
120 planned
Interventions
The wearable gait-assist robot ANGEL SUIT H10 (Angel Robotics Co; Class II medical device, powered orthopedic exercise device, certificate No; maximum assist torque is 15 Nm (10 Nm continuous); no dose-matching with an equal duration of standard rehabilitation is applied; IPTW as sensitivity analysis)
Ages
adults, older adults
Registry
KCT0012622

Full record on CRiSSource: WHO ICTRP, processed 5 October 2026

Primary outcomes

  • Isokinetic knee extensor strength of the operated side (Biodex, 60°/s peak torque, Nm) - knee cohort. Estimated as a propensity-score-adjusted mean difference with 95% CI versus the historical standard-rehabilitation control group
  • Feasibility and safety - hip cohort: session completion rate, adverse events (CTCAE v5.0
  • WHO-UMC causality), pain (VAS), walking distance. Single-group description without a historical control

History

  1. Last registry update

  2. Started

  3. Registered