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Not yet recruitingNCT07902102Updated Nov 2, 2026

Smart Sock for Monitoring Walking and Supporting Physical Activity in Older Adults

An interventional study of Low-Cost Smart Sock and Older-Adult Mobile Application and Standard Individual Walking Plan in Walking Mesh, sponsored by University of Malaya. Not yet recruiting. Open to participants aged 60 Days and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by University of Malaya · Not applicable, Interventional, and Prevention

Updated Nov 2, 2026Primary outcomes revisedInterventions changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
60 Days and older
Sex
All
01

Study summary

The goal of this randomized feasibility clinical trial is to learn whether a low-cost smart sock and mobile application can be used safely, reliably, and comfortably to support gradual walking activity in adults aged 60 years and older. The smart sock is a research prototype worn with the participant's usual footwear. It records simple walking information, such as step timing and walking rhythm, and sends a summary to a mobile application. The application provides an individual walking plan, asks about perceived effort and symptoms, and shows simple messages about whether the participant should continue, repeat the current level, or pause and seek review.

The study will include community-dwelling adults aged 60 years or older who can walk independently, with or without a usual walking aid when this is considered safe. This study does not diagnose medical conditions, predict falls, provide emergency monitoring, or replace medical care.

The main questions this study aims to answer are:

  • Can older adults use the smart sock and application comfortably and complete the planned walking sessions?
  • Does the smart sock record step events and walking cadence accurately enough for this type of monitoring?
  • Are the application instructions, safety messages, and optional family-support feature understandable and acceptable to older adults?
  • Can the study procedures be delivered safely, including device fitting, battery charging, walking progression, and reporting of symptoms or falls?
  • What changes are seen over 12 weeks in walking activity and supervised functional assessments?

Researchers will compare a smart-sock-supported adaptive walking group with a comparison group receiving a standard individual walking plan. Participants will be assigned to one of the two groups by chance. The smart-sock group will use the device and app, which may adjust the walking plan conservatively when repeated sessions are completed at an acceptable effort and no safety concerns are reported. Participants in this group may choose a trusted family member or helper to receive limited notifications, such as "session completed" or "please check in." Family members will not see sensor data, symptoms, health history, test results, or decisions about walking progression. The comparison group will follow a standard nonadaptive walking plan independently and will not receive the smart sock, individualized app feedback, or study-provided family support.

Participants will:

  • Complete screening, provide informed consent, and take part in a supervised baseline visit.
  • Complete walking-related assessments at baseline, Week 6, and Week 12, including a 6-minute walk test, Timed Up and Go test, and 30-second chair-stand test.
  • Follow an individual walking plan for 12 weeks, usually with three to five sessions per week.
  • In the smart-sock group, wear the smart sock during planned sessions and use the mobile application to record session completion, perceived effort, and any symptoms.
  • Report falls, near-falls, pain, dizziness, unusual shortness of breath, device discomfort, or technical problems.

Participants can stop a walking session at any time. The walking plan will not progress if there are warning symptoms, a fall, high perceived effort, concerning changes in walking information, or a decline at supervised reassessment. The study team may pause, simplify, or review the plan when needed.

Read the detailed description

This study evaluates a low-cost, foot-worn sensing prototype and mobile application intended to support gradual walking activity in older adults. Many commercially available activity tools provide step counts or fixed goals but do not combine simple foot-level movement information, perceived effort, symptom reporting, and conservative progression rules. The proposed system is designed to explore whether a simpler and more accessible approach can be implemented reliably in community-dwelling older adults.

The smart sock is a removable research prototype used with ordinary footwear. Its sensing module combines an FSR402 force-sensitive resistor placed beneath the forefoot with the integrated inertial measurement unit in a Seeed Studio XIAO nRF52840 Sense board. The FSR402 is used to identify changes in foot contact, while the inertial sensor records patterns of acceleration and angular movement. These signals are used to derive step events, cadence, inter-step timing, and simple indicators of walking rhythm. The system is intended for activity monitoring and coaching only. It is not designed to diagnose disease, measure laboratory-grade plantar pressure, estimate oxygen consumption, predict falls, provide emergency alerts, or replace clinical assessment.

The prototype is built from readily available components to support reproducibility and low cost. It includes a protected 3.7-V lithium-polymer battery, a 3.3-kΩ 1/4-W metal-film resistor, flexible insulated wire, a small green perforated FR-4 prototype printed circuit board, and a removable protective enclosure. The FSR402 and resistor form a 3.3-V voltage-divider circuit connected to the analog input of the XIAO board. The board uses Bluetooth Low Energy to send session summaries to the mobile application. The electronics are enclosed and positioned above the foot or near the shoe laces; the sensor sits beneath the removable insole at the forefoot. The battery is not charged while the device is worn or inside the shoe.

The mobile application is designed specifically for older adults. Its interface uses large high-contrast text, clear icons, plain-language prompts, minimal navigation, optional audio prompts, and a direct method to pause a session or report a symptom. Rather than showing complex sensor graphs, the application provides a small number of understandable messages about the current walking plan, session completion, perceived effort, and whether the current level should be maintained, reviewed for cautious progression, or paused.

The progression approach is intentionally conservative. The application does not advance activity after a single successful session. It considers repeated session completion, perceived exertion within the intended range, absence of a reported fall or warning symptom, and the absence of concerning changes in the derived walking indicators. When conditions are favorable, only one part of the walking plan is changed at a time, such as a small increase in walking duration or a reduction in a planned recovery period. A report of pain, dizziness, unusual shortness of breath, a fall, high perceived effort, device discomfort, or a concerning walking trend leads to pausing, repeating, simplifying, or reviewing the plan rather than automatic progression.

The application includes an optional participant-controlled family-support function. If a participant chooses this option, a trusted family member or helper may receive limited practical notifications, such as that a session was completed, paused, or that a check-in may be helpful. The support person cannot see raw sensor information, perceived-effort ratings, symptoms, health history, functional-assessment results, or the application's progression rule. They cannot change the participant's settings, override an alert, or make a progression decision. This feature is intended to support encouragement and practical assistance while preserving participant autonomy and privacy.

The study will document whether the hardware, software, instructions, and monitoring workflow can be delivered as planned and whether the system produces usable information for a later, appropriately powered effectiveness study. Technical assessment will focus on agreement of device-derived step events and cadence with reference observations. Implementation assessment will consider wearable fit, battery and charging performance, data transfer, technical faults, ease of setup, device comfort, accessibility of the application, and acceptability of optional family support. Information collected by the application will be limited to data necessary for monitoring and evaluation, including time-stamped step events or derived features, session information, perceived effort, symptom reports, app status, technical logs, and selected family-support preferences. Data will be handled through institutionally approved, secure procedures.

02

Conditions studied

  • Walking Mesh
03

In context

Lead sponsor

University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Days and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 60 years or older.
  • Living in the community (not residing in an institutional care facility).
  • Able to walk independently, with or without a customary walking aid, when considered safe by the study team.
  • Insufficiently active or interested in improving regular walking activity.
  • Has a compatible smartphone or access to a study-supported smartphone.
  • Able to understand study instructions and use the application independently or with assistance from a participant-selected helper.
  • Able and willing to provide written .
  • Willing to wear the smart sock during planned sessions and complete study assessments and follow-up procedures.

Exclusion criteria

Exclusion Criteria:

  • Chest pain during physical activity or at rest that has not been medically assessed.
  • Unexplained dizziness, fainting, or loss of consciousness.
  • Acute lower-limb injury, severe foot pain, or another condition that prevents safe walking.
  • Unstable medical condition or a condition for which gradual unsupervised walking progression is considered inappropriate.
  • A fall in the recent period that required medical attention, unless cleared by an appropriate health professional.
  • Severe cognitive, visual, hearing, or communication difficulty that prevents , understanding of safety instructions, or safe participation.
  • Any other condition identified during pre-exercise screening that requires medical review before increasing physical activity.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Adaptive Smart Sock and Mobile Application

    Participants will use a low-cost smart sock and an older-adult mobile application for 12 weeks. The smart sock records step timing, cadence, and walking-rhythm indicators and sends session summaries to the app through Bluetooth Low Energy. The app provides an individual walking plan, session-completion prompts, rating of perceived exertion and symptom reporting, simple walking-trend feedback, conservative progression rules, and optional privacy-controlled family-support notifications. The system is not intended to diagnose disease, predict falls, provide emergency monitoring, or replace clinical assessment

    Device: Low-Cost Smart Sock and Older-Adult Mobile Application

  • Active comparator
    Standard Individual Walking Plan

    Participants will follow a standard, nonadaptive individual walking plan for 12 weeks. The plan includes the same broad recommended walking frequency, safety information, and scheduled study contact. Participants will complete the program independently and will not receive the smart sock, individualized mobile-app feedback, automated progression, or study-provided family support

    Other: Standard Individual Walking Plan

Interventions

  • DeviceLow-Cost Smart Sock and Older-Adult Mobile Application

    A low-cost foot-worn research prototype and mobile application for monitoring walking-related information and supporting gradual physical activity in adults aged 60 years and older. The device includes an FSR402 force-sensitive resistor, Seeed Studio XIAO nRF52840 Sense board with integrated motion sensor, protected 3.7-V lithium-polymer battery, and Bluetooth Low Energy connectivity. The application provides an individual walking plan, session completion prompts, perceived-exertion and symptom reporting, simple walking-trend feedback, conservative progression rules, and optional privacy-controlled family-support notifications. The system is not intended to diagnose disease, predict falls, provide emergency monitoring, or replace clinical assessment.

  • OtherStandard Individual Walking Plan

    A standard, nonadaptive individual walking plan with safety information and scheduled study contact. Participants complete the plan independently and do not receive the smart sock, individualized application feedback, automated progression, or study-provided family support.

06

What researchers measure

Primary outcomes

  1. Rating of Perceived Exertion During Walking Sessions

    Participants will rate their perceived physical effort after each planned walking session using a 10-point Rating of Perceived Exertion scale. Scores range from 1 to 10, where 1 indicates very light effort and 10 indicates maximal perceived effort. Higher scores indicate greater perceived exertion and may indicate lower exercise tolerance or a need to pause, repeat, or simplify the current walking plan.

    Time frame: Week 1 through Week 12

  2. Smart-Sock and Mobile-Application Data Completeness

    Percentage of expected device and application data records available for analysis. Scores range from 0% to 100%; higher percentages indicate better data completeness.

    Time frame: Baseline through Week 12

  3. Safety Events

    Number of reported falls, near-falls, warning symptoms, device discomfort events, battery/charging concerns, and technical faults. Lower numbers indicate better safety and technical acceptability.

    Time frame: Baseline through Week 12

Secondary outcomes

  1. Six-Minute Walk Test Distance

    Distance walked during the Six-Minute Walk Test, measured in meters. Higher distance indicates better walking endurance.

    Time frame: Baseline, Week 6, and Week 12

  2. Timed Up and Go Test Time

    Time required to stand from a chair, walk 3 meters, turn, walk back, and sit down, measured in seconds. Lower time indicates better functional mobility.

    Time frame: Baseline, Week 6, and Week 12

  3. 30-Second Chair Stand Test Repetitions

    Percentage of planned walking sessions completed during the intervention. Scores range from 0% to 100%; higher percentages indicate better adherence.

    Time frame: Baseline, Week 6, and Week 12

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Prasanth H, Caban M, Keller U, Courtine G, Ijspeert A, Vallery H, von Zitzewitz J. Wearable Sensor-Based Real-Time Gait Detection: A Systematic Review. Sensors (Basel). 2021 Apr 13;21(8):2727. doi: 10.3390/s21082727. PubMed 33924403 ↗

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Interventions
Arm changed Experimental→Adaptive Smart Sock and Mobile Application; Comparator→Standard Individual Walking Plan
Nov 2, 2026
Primary outcomes
3 added, 1 removed
What changed in the outcomes
  • AddedRating of Perceived Exertion During Walking SessionsTime frame: Week 1 through Week 12
  • AddedSmart-Sock and Mobile-Application Data CompletenessTime frame: Baseline through Week 12
  • AddedSafety EventsTime frame: Baseline through Week 12
  • RemovedFeasibility of the Low-Cost Smart Sock and Older-Adult Mobile Application InterventionTime frame: Baseline through Week 12
Nov 2, 2026
Secondary outcomes
3 added
What changed in the outcomes
  • AddedSix-Minute Walk Test DistanceTime frame: Baseline, Week 6, and Week 12
  • AddedTimed Up and Go Test TimeTime frame: Baseline, Week 6, and Week 12
  • Added30-Second Chair Stand Test RepetitionsTime frame: Baseline, Week 6, and Week 12
Nov 2, 2026
Title
Smart Sock for Monitoring Walking and Supporting Physical Activity in Older Adults: A Family-Supported Feasibility Study
Nov 2, 2026
Registered
First appeared on the registry
Oct 28, 2026
Show all 2 updates
  1. Nov 2, 2026
    Primary outcomes 3 added, 1 removed
    What changed in the outcomes
    • AddedRating of Perceived Exertion During Walking SessionsTime frame: Week 1 through Week 12
    • AddedSmart-Sock and Mobile-Application Data CompletenessTime frame: Baseline through Week 12
    • AddedSafety EventsTime frame: Baseline through Week 12
    • RemovedFeasibility of the Low-Cost Smart Sock and Older-Adult Mobile Application InterventionTime frame: Baseline through Week 12
    Secondary outcomes 3 added
    What changed in the outcomes
    • AddedSix-Minute Walk Test DistanceTime frame: Baseline, Week 6, and Week 12
    • AddedTimed Up and Go Test TimeTime frame: Baseline, Week 6, and Week 12
    • Added30-Second Chair Stand Test RepetitionsTime frame: Baseline, Week 6, and Week 12
    Interventions Arm changed Experimental→Adaptive Smart Sock and Mobile Application; Comparator→Standard Individual Walking Plan
    Title Smart Sock for Monitoring Walking and Supporting Physical Activity in Older Adults: A Family-Supported Feasibility Study
  2. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902102
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Azari J Medhir, PhD
Contact
moh37471@gmail.com
+60 199561806 ext. +966 544152309

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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