Rehabilitation ExerciseNCT06970717
Programmable Smart Watch for Remote Pre-habilitation/Rehabilitation Monitoring
A study testing M5Stick Programmable watch in people with Rehabilitation Exercise, run by Changi General Hospital at 1 site in Singapore.
Trial summary
The purpose of this research study is to validate the M5Stick Programmable watch as a prototype to monitor specific prehabilitation exercises and to monitor the frequency of exercises and the number of repetitions the subject makes in a home setting. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation Exercise
- What is being tested?
- M5Stick Programmable watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-60
- Not on follow up for chronic diseases
- Willing to perform exercises daily x 5 days
- Able to handle simple technology eg. smart phone
Who cannot join
- Pregnant women
- Active joint pains and any other musculoskeletal issues
- Heart conditions or balance issues
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Changi General Hospital
Singapore, Singapore, 529889
San San Tay, MBBS, +6569366455, tay.san.san@singhealth.com.sg
About this study
The purpose of this research study is to validate the M5Stick Programmable watch as a prototype to monitor specific prehabilitation exercises and to monitor the frequency of exercises and the number of repetitions the subject makes in a home setting.
Read the detailed description
Background of study Locally, a digital platform, the Cancer prehabilitation exercise diary was developed by Singhealth Marcom with Changi General Hospital (CGH) to support a home-based cancer prehabilitation program complete with exercise videos and reminders. The disadvantage of home-based or remote rehabilitation and prehabilitation compared to a centre-based treatment is that of a lack of monitoring and reduced compliance. In the CGH home-based model of cancer prehabilitation, compliance is monitored by verbal confirmation over a telephone call made by the cancer prehabilitation coordinator at mid-point of the course, and then with verbal checking with the patient at the end of the prehabilitation program, at the pre-op visit.
With the direction of increased digitalization for healthcare of the future, there is a desire to develop a smart watch that allows for the monitoring of the frequency and accuracy of the exercises prescribed asynchronously. A summary of the patient's exercise frequency/intensity and accuracy can be gathered from the app on the accompanying tablet.
This prototype will be developed through collaboration with the Eastern General Hospital {EGH) Engineering department. There is currently no product on the market that will be customizable for the specific calisthenic and plyometric exercises that are part of the cancer prehabilitation exercise videos.
Specific aims of this study This study aims to validate the MSStick Programmable watch as a prototype to monitor specific prehabilitation exercises and to monitor the frequency of exercises and the number of repetitions the subject makes in a home setting.
Hypothesis of this study The hypothesis is that the MSStick Programmable watch is able to monitor the specific prehabilitation exercises performed in a home-setting by healthy volunteers, and is able to distinguish its frequency and number of repetitions
Importance of this study This project aims to develop a programmable smartwatch for remote prehabilitation/rehabilitation monitoring. We address the limitations of current home-based programs by enabling asynchronous monitoring of exercise frequency, accuracy, and intensity. The smartwatch utilizes a 6-axis Inertial Measurement Unit (IMU) to differentiate specific exercises and measure workout intensity.
Prototype validation will involve 20 healthy volunteers performing 7 pre-defined exercises. The smartwatch will capture data and compare it with volunteer logs to assess Its ability to capture specific and accurate data.
Based on the findings, further refinement of the programming, prototype, and work processes may be necessary. Future steps include cloud-based data transmission, commercialization, and validation with specific patient populations. This smartwatch has the potential to be an important tool for scaling up telerehabilitation and teleprehabilitation programs.
- Conditions
- Rehabilitation Exercise
- Being tested
- M5Stick Programmable watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M5Stick Programmable watchDevice
This smart watch is fashioned using a M5StickC, an IOT platform which is programmable and allows us to measure specific exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Device: M5Stick Programmable watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Compliance
Measure if the exercises were performed as prescribed, based on the number of repetitions, the number of sets of exercises and the frequency of exercise
Measured: Over 1 week
Secondary outcomes (1)
Usability
A survey using the mhealth usability questionaire, with 18 questions, each question with scores of 1 to 7, 7 being fully agree and 1 fully disagree.
Measured: over 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation ExerciseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 healthy volunteers will be recruited via hospital posters and email. Volunteers will receive a smartwatch and tablet for one week. After consent, they'll be shown 7 standard cancer prehabilitation exercises (Squat Chop, Ice-skater, Dig and Flex, Tap and Punch, March and Twist, Cross Punch, Sit-to-stand) demonstrated by a team member, and given exercise videos (via tablet/QR code). The 20-minute exercise session will be supervised, with posture correction and home exercise tips. Smartwatch data will be captured during the supervised session. Volunteers will then wear the watch and follow the videos for 5 days, exercising at their convenience, logging activity, and transmitting data to the tablet. No personal data will be entered. Finally, volunteers return the devices and complete a usability survey. Data will be compared against logs to assess accuracy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970717
- Sponsor's protocol ID
- 2024/4048
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is protected under the SingHealth Data Protection Policy which is compliant to the Singapore Personal Data Protection Act 2012
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmable Smart Watch for Remote Pre-habilitation/Rehabilitation Monitoring
- ClinicalTrials.gov ID
- NCT06970717
- Acronym / sponsor ID
- 2024/4048
- Conditions
- Rehabilitation Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 May 2025 (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.
The purpose of this research study is to validate the M5Stick Programmable watch as a prototype to monitor specific prehabilitation exercises and to monitor the frequency of exercises and the number of repetitions the subject makes in a home setting.
Detailed description
Background of study Locally, a digital platform, the Cancer prehabilitation exercise diary was developed by Singhealth Marcom with Changi General Hospital (CGH) to support a home-based cancer prehabilitation program complete with exercise videos and reminders. The disadvantage of home-based or remote rehabilitation and prehabilitation compared to a centre-based treatment is that of a lack of monitoring and reduced compliance. In the CGH home-based model of cancer prehabilitation, compliance is monitored by verbal confirmation over a telephone call made by the cancer prehabilitation coordinator at mid-point of the course, and then with verbal checking with the patient at the end of the prehabilitation program, at the pre-op visit.
With the direction of increased digitalization for healthcare of the future, there is a desire to develop a smart watch that allows for the monitoring of the frequency and accuracy of the exercises prescribed asynchronously. A summary of the patient's exercise frequency/intensity and accuracy can be gathered from the app on the accompanying tablet.
This prototype will be developed through collaboration with the Eastern General Hospital {EGH) Engineering department. There is currently no product on the market that will be customizable for the specific calisthenic and plyometric exercises that are part of the cancer prehabilitation exercise videos.
Specific aims of this study This study aims to validate the MSStick Programmable watch as a prototype to monitor specific prehabilitation exercises and to monitor the frequency of exercises and the number of repetitions the subject makes in a home setting.
Hypothesis of this study The hypothesis is that the MSStick Programmable watch is able to monitor the specific prehabilitation exercises performed in a home-setting by healthy volunteers, and is able to distinguish its frequency and number of repetitions
Importance of this study This project aims to develop a programmable smartwatch for remote prehabilitation/rehabilitation monitoring. We address the limitations of current home-based programs by enabling asynchronous monitoring of exercise frequency, accuracy, and intensity. The smartwatch utilizes a 6-axis Inertial Measurement Unit (IMU) to differentiate specific exercises and measure workout intensity.
Prototype validation will involve 20 healthy volunteers performing 7 pre-defined exercises. The smartwatch will capture data and compare it with volunteer logs to assess Its ability to capture specific and accurate data.
Based on the findings, further refinement of the programming, prototype, and work processes may be necessary. Future steps include cloud-based data transmission, commercialization, and validation with specific patient populations. This smartwatch has the potential to be an important tool for scaling up telerehabilitation and teleprehabilitation programs.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 healthy volunteers will be recruited via hospital posters and email. Volunteers will receive a smartwatch and tablet for one week. After consent, they'll be shown 7 standard cancer prehabilitation exercises (Squat Chop, Ice-skater, Dig and Flex, Tap and Punch, March and Twist, Cross Punch, Sit-to-stand) demonstrated by a team member, and given exercise videos (via tablet/QR code). The 20-minute exercise session will be supervised, with posture correction and home exercise tips. Smartwatch data will be captured during the supervised session. Volunteers will then wear the watch and follow the videos for 5 days, exercising at their convenience, logging activity, and transmitting data to the tablet. No personal data will be entered. Finally, volunteers return the devices and complete a usability survey. Data will be compared against logs to assess accuracy.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: M5Stick Programmable watch |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 21-60
- Not on follow up for chronic diseases
- Willing to perform exercises daily x 5 days
- Able to handle simple technology eg. smart phone
Key exclusion criteria (3 listed)
- Pregnant women
- Active joint pains and any other musculoskeletal issues
- Heart conditions or balance issues
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 |
|---|---|---|
| M5Stick Programmable watchThis smart watch is fashioned using a M5StickC, an IOT platform which is programmable and allows us to measure specific exercises. | Device | Intervention arm |
Primary outcome
Exercise Compliance
Time frame: Over 1 week
Measure if the exercises were performed as prescribed, based on the number of repetitions, the number of sets of exercises and the frequency of exercise
1 secondary outcome
Usability
Time frame: over 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No. Data is protected under the SingHealth Data Protection Policy which is compliant to the Singapore Personal Data Protection Act 2012
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M5Stick Programmable watch in people with Rehabilitation Exercise, run by Changi General 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact San San Tay, MBBS (65 69366455, tay.san.san@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Compliance (time frame: Over 1 week). 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 14 May 2025.