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Development of a Digital Rehab Program With Gamification

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 1 word
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Total knee arthroplasty is commonly followed by a period of postoperative rehabilitation to restore knee movement, lower-limb strength, and physical function. This randomized study evaluated KIMIA Recover, a wearable sensor-supported home rehabilitation system, in patients undergoing first-time unilateral total knee arthroplasty. Participants were randomly allocated to KIMIA Recover-supported rehabilitation or conventional postoperative rehabilitation and followed for 12 weeks after surgery. KIMIA Recover comprises a wearable knee motion sensor, a patient mobile application providing guided rehabilitation exercises and feedback, and a clinician dashboard that enables review of rehabilitation progress. Outcomes included knee range of motion, 30-second sit-to-stand performance, health-related quality of life, healthcare resource use and costs, quadriceps strength, straight-leg-raise ability, walking-device use, Oxford Knee Score, and postoperative complications. The randomized phase was originally designed to recruit a larger cohort but enrolled 21 participants. Because recruitment and follow-up were limited, the completed study is being reported as a pilot and feasibility evaluation, with clinical between-group comparisons considered exploratory. This ClinicalTrials.gov record is being registered retrospectively after completion of participant recruitment and follow-up.
Trial Details
NCT Number NCT07845539
Lead Sponsor Tan Tock Seng Hospital
Collaborators: Kinexcs Private Limited
Conditions
(from sponsor)
Knee Osteoarthristis
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov