Knee OsteoarthristisNCT07845539
Development of a Digital Rehab Program With Gamification
A study testing KIMIA Recover and Conventional Postoperative Rehabilitation in people with Knee Osteoarthristis, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- KIMIA Recover and Conventional Postoperative Rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Nov 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Clinical Validation of a Novel Digital Rehabilitative Exercise Program With Gamification and Vision Technology
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.
Read more
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.
Read the detailed description
KIMIA Recover is a postoperative rehabilitation system comprising a wearable knee motion sensor, a patient-facing mobile application, and a clinician dashboard. The wearable sensor records knee movement and rehabilitation activity. The mobile application provides rehabilitation education, guided exercise instructions, visual and audio cues, feedback, progress tracking, and notifications linked to prescribed exercises. The clinician dashboard allows healthcare professionals to remotely review rehabilitation progress and exercise participation.
Eligible participants undergoing first-time unilateral total knee arthroplasty were randomized in a 1:1 ratio to KIMIA Recover-supported rehabilitation or conventional rehabilitation using a computer-generated block-randomization sequence with block sizes of four. Because of the nature of the intervention, participants and investigators were not blinded.
All participants received usual perioperative care and postoperative rehabilitation according to the institutional rehabilitation pathway. Participants allocated to KIMIA Recover additionally received the wearable sensor and mobile application and were instructed to use the system for up to 12 weeks following surgery. The sensor was intended to be worn for 12-16 hours per day during the inpatient period and for 8-12 hours per day during active and exercising hours following discharge.
Participants allocated to conventional rehabilitation performed prescribed home rehabilitation exercises without technology-supported monitoring and could attend outpatient physiotherapy according to clinical need.
Clinical and patient-reported assessments were performed at baseline and postoperative follow-up, including approximately four and 12 weeks after total knee arthroplasty.
- Conditions
- Knee Osteoarthristis
- Being tested
- KIMIA Recover, Conventional Postoperative Rehabilitation
- Keywords
- Total knee arthroplasty, Postoperative rehabilitation, Digital rehabilitation, Range of motion, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIMIA RecoverDevice
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
Conventional Postoperative RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional Postoperative Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient retention
Patient retention and drop out rate
Measured: 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.
Measured: 4 weeks (±2 weeks) and 12 weeks (±2 weeks) after total knee arthroplasty
Secondary outcomes (3)
Change in Quadriceps Muscle Strength
Quadriceps muscle strength of the operated limb assessed clinically by a physiotherapist or investigator using the institutional clinical muscle-strength grading method.
Measured: Baseline, 4 weeks (±2 weeks), and 12 weeks (±2 weeks) after total knee arthroplasty
Change in Knee Range of Motion
Knee flexion and extension range of motion measured in degrees using a goniometer by a physiotherapist, clinician, or trained study team member.
Measured: Baseline, 4 weeks (±2 weeks), and 12 weeks (±2 weeks) after total knee arthroplasty
Change in Oxford Knee Score
Patient-reported knee-related pain and functional status assessed using the Oxford Knee Score.
Measured: Baseline and 12 weeks after total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start24 Nov 2024
- Primary completion19 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kinexcs Private Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845539
- Sponsor's protocol ID
- DSRB 2024-3584
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of a Novel Digital Rehabilitative Exercise Program With Gamification and Vision Technology
- ClinicalTrials.gov ID
- NCT07845539
- Acronym / sponsor ID
- DSRB 2024-3584
- Conditions
- Knee Osteoarthristis
- Keywords
- Total knee arthroplasty, Postoperative rehabilitation, Digital rehabilitation, Range of motion, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Kinexcs Private Limited
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
KIMIA Recover is a postoperative rehabilitation system comprising a wearable knee motion sensor, a patient-facing mobile application, and a clinician dashboard. The wearable sensor records knee movement and rehabilitation activity. The mobile application provides rehabilitation education, guided exercise instructions, visual and audio cues, feedback, progress tracking, and notifications linked to prescribed exercises. The clinician dashboard allows healthcare professionals to remotely review rehabilitation progress and exercise participation.
Eligible participants undergoing first-time unilateral total knee arthroplasty were randomized in a 1:1 ratio to KIMIA Recover-supported rehabilitation or conventional rehabilitation using a computer-generated block-randomization sequence with block sizes of four. Because of the nature of the intervention, participants and investigators were not blinded.
All participants received usual perioperative care and postoperative rehabilitation according to the institutional rehabilitation pathway. Participants allocated to KIMIA Recover additionally received the wearable sensor and mobile application and were instructed to use the system for up to 12 weeks following surgery. The sensor was intended to be worn for 12-16 hours per day during the inpatient period and for 8-12 hours per day during active and exercising hours following discharge.
Participants allocated to conventional rehabilitation performed prescribed home rehabilitation exercises without technology-supported monitoring and could attend outpatient physiotherapy according to clinical need.
Clinical and patient-reported assessments were performed at baseline and postoperative follow-up, including approximately four and 12 weeks after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIMIA Recover-Supported Rehabilitation | Experimental | Device: KIMIA RecoverParticipants 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. |
| Standard-of-Care Rehabilitation | Active comparator | Behavioral: Conventional Postoperative RehabilitationParticipants 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIMIA RecoverKIMIA 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 | Device | KIMIA Recover-Supported Rehabilitation |
| Conventional Postoperative RehabilitationParticipants 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. | Behavioural | Standard-of-Care Rehabilitation |
Primary outcome
Patient retention
Time frame: 0,4,12 weeks
Patient retention and drop out rate
Postoperative Complications
Time frame: 4 weeks (±2 weeks) and 12 weeks (±2 weeks) after total knee arthroplasty
Number and proportion of participants experiencing postoperative complications or adverse effects following total knee arthroplasty during the study follow-up period.
3 secondary outcomes
Change in Quadriceps Muscle Strength
Time frame: Baseline, 4 weeks (±2 weeks), and 12 weeks (±2 weeks) after total knee arthroplasty
Change in Knee Range of Motion
Time frame: Baseline, 4 weeks (±2 weeks), and 12 weeks (±2 weeks) after total knee arthroplasty
Change in Oxford Knee Score
Time frame: Baseline and 12 weeks after total knee arthroplasty
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIMIA Recover and Conventional Postoperative Rehabilitation in people with Knee Osteoarthristis, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient retention (time frame: 0,4,12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.