Clinical trial NCT06970717: Programmable Smart Watch for Remote Pre-habilitation/Rehabilitation Monitoring
Official title: Programmable Smart Watch for Remote Pre-habilitation/Rehabilitation Monitoring
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation Exercise
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 21-60
2. Not on follow up for chronic diseases
3. Willing to perform exercises daily x 5 days
4. Able to handle simple technology eg. smart phone

Exclusion Criteria:

1. Pregnant women
2. Active joint pains and any other musculoskeletal issues
3. Heart conditions or balance issues

Primary outcomes:
measure: Exercise Compliance
timeFrame: Over 1 week
Secondary outcomes:
measure: Usability
timeFrame: over 1 week
Other outcomes:
measure: Technical reliability
timeFrame: over 1 week
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References: