Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming

Sponsor
Imperial College London
Study ID
NCT07555795
Status
Recruiting
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Conditions

  • Low Back Pain
  • Non-specific Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MMG-biofeedback belt — DEVICE
    The intervention consists of a wearable belt incorporating mechanomyography (MMG) sensors to detect muscle activity in the abdominal and lower back regions, paired with a mobile application that provides real-time visual feedback on core muscle activation during exercise. The system is designed to guide users in engaging the correct muscles, improve exercise performance, and support adherence to a prescribed exercise programme during both supervised and home-based sessions.

Study Details

The goal of this clinical trial is to evaluate whether a wearable biofeedback smartbelt system can improve pain and disability in adults with chronic lower back pain. The intervention combines a wearable belt that measures muscle activity with a mobile application that provides real-time feedback during exercise. The main questions it aims to answer are: * Does the MMG-biofeedback system improve disability, as measured by the Oswestry Disability Index (ODI), compared to standard care alone over an 8-week period? * Does the system reduce perceived pain levels and improve exercise adherence in individuals with lower back pain over an 8-week period? Researchers will compare participants receiving the MMG-biofeedback belt alongside standard care to those receiving standard care alone to determine whether the addition of real-time muscle activation feedback leads to improved outcomes. Participants will: * Be randomly assigned to either the intervention group (biofeedback system + standard care) or control group (standard care only) * Complete an 8-week home-based exercise programme, all participants are asked to complete the programme at least 5 times a week * Use the wearable belt and mobile application during exercise sessions (intervention group only) * Receive a booklet with the exercise programme and video links (control group only) * Complete questionnaires on pain, disability, and usability at baseline and after 8 weeks, and at a 3-month follow-up * Have their exercise adherence and engagement monitored throughout the study The study includes an initial pilot phase to assess feasibility, followed by a larger randomised controlled phase to evaluate early clinical effectiveness.

Key Dates

First listed
Apr 29, 2026
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Apr 20, 2027
Completion
Apr 20, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exercise with real-time muscle biofeedback
    Participants randomised to the intervention arm will receive a standardised lab session on the use of the MMG-biofeedback belt and mobile application. A physiotherapist or trained researcher will demonstrate how to perform each exercise, correct belt positioning, app navigation, calibration procedures, and how to interpret the real-time muscle activation feedback. Participants will be issued the MMG-biofeedback belt and app after training and will use the system throughout their prescribed home-based exercise sessions for the full eight-week intervention period. Participants are asked to perform the exercise programme (20-30 mins) at least 5 times a week. The app will provide real-time feedback on muscle activation, progress summaries and reminders. Participants are asked to carry on any other treatment as usual. Aside from routine data collection and belt troubleshooting, participants in the control group will not receive additional input from the research team.
  • No Intervention: Exercise without biofeedback (waitlist control)
    Participants randomised to the control arm will receive a standardised lab session, whereby core strength and endurance measures are taken. A physiotherapist or trained researcher will demonstrate how to perform each exercise. Participants will be issued with a booklet containing the exercise programme with exercise video links and are asked to perform their prescribed home-based exercise sessions for the full eight-week intervention period. Participants are asked to perform the exercise programme (20-30 mins) at least 5 times a week. No MMG-biofeedback belt will be provided to this group, participants are asked to carry on any other treatment as usual. Aside from routine data collection, participants in the control group will not receive additional input from the research team.

Primary Outcome Measure

Oswestry Disability Index [ Time Frame: From enrollment to 3 months after the end of treatment period (8 weeks treatment) ]

Central Contacts

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