Development of a Digital Rehab Program With Gamification

NCT07845539 | Completed

• 1 other identifier: DSRB 2024-3584
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthristis

Keywords

Total knee arthroplasty; Postoperative rehabilitation; Digital rehabilitation; Range of motion; Physical therapy

Outcome Measures

Primary Outcomes (2)

• Patient retention

  Patient retention and drop out rate

  0,4,12 weeks

• Postoperative Complications

  Number and proportion of participants experiencing postoperative complications or adverse effects following total knee arthroplasty during the study follow-up period.

  4 weeks (±2 weeks) and 12 weeks (±2 weeks) after total knee arthroplasty

Secondary Outcomes (3)

• Change in Quadriceps Muscle Strength

  Baseline, 4 weeks (±2 weeks), and 12 weeks (±2 weeks) after total knee arthroplasty

• Change in Knee Range of Motion

  Baseline, 4 weeks (±2 weeks), and 12 weeks (±2 weeks) after total knee arthroplasty

• Change in Oxford Knee Score

  Baseline and 12 weeks after total knee arthroplasty

Study Arms (2)

KIMIA Recover-Supported Rehabilitation

EXPERIMENTAL

Participants received usual perioperative and postoperative rehabilitation together with KIMIA Recover, comprising a wearable knee motion sensor, mobile rehabilitation application, and clinician dashboard. Participants were trained to use the sensor and application and were instructed to use the system during inpatient rehabilitation and for up to 12 weeks following total knee arthroplasty.

Device: KIMIA Recover

Standard-of-Care Rehabilitation

ACTIVE COMPARATOR

Participants received usual perioperative rehabilitation and conventional home-based postoperative rehabilitation without technology-supported monitoring. They were provided with prescribed rehabilitation exercises and could attend outpatient physiotherapy according to clinical need.

Behavioral: Conventional Postoperative Rehabilitation

Interventions

KIMIA Recover DEVICE

KIMIA Recover is a wearable sensor-supported postoperative rehabilitation system comprising a knee motion sensor, patient mobile application, and clinician dashboard. The application provides rehabilitation education, guided exercises, visual and audio cues, feedback, reminders, and progress tracking. The clinician dashboard enables healthcare professionals to review rehabilitation progress and exercise participation. Participants were instructed to wear the sensor for 12-16 hours per day during the inpatient period and for 8-12 hours per day during active and exercise periods after discharge, for up to 12 weeks

KIMIA Recover-Supported Rehabilitation

Conventional Postoperative Rehabilitation BEHAVIORAL

Participants performed prescribed home rehabilitation exercises without wearable or application-based monitoring. Outpatient physiotherapy was provided according to clinical need, including assessment of recovery, exercise instruction, feedback, and progression of exercises.

Standard-of-Care Rehabilitation

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time unilateral total knee replacement
• Eligible for the institutional Enhanced Recovery After Surgery programme
• Age 21 to 90 years
• Able to provide written informed consent
• Proficient in smartphone use
• Adequate cognitive function to understand and comply with study instructions
• No uncontrolled medical condition expected to adversely affect postoperative outcomes
• Willing to comply with study procedures and follow-up

You may not qualify if:

• Previous total knee replacement of the contralateral knee or scheduled revision total knee replacement
• Limb disorder that may interfere with measurement of knee movement
• Planned discharge to a destination other than home
• Difficulty following, applying, or using the KIMIA Recover system
• Previous lower-limb surgery other than total knee replacement
• Dependence in activities of daily living requiring caregiver assistance
• Scheduled partial or unicompartmental knee replacement
• Significant cognitive impairment or dementia that may interfere with study participation
• Unable to establish or maintain reliable communication with the study team
• Poorly controlled medical conditions, including uncontrolled diabetes, hypertension, metabolic disease, or cardiovascular disease
• Pregnancy

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Kinexcs Private Limited: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators were not blinded because the intervention required participants to use a wearable sensor and mobile rehabilitation application.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: November 24, 2024
• Primary Completion: August 19, 2025
• Study Completion: August 30, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

SG (1)