RecruitingNot Applicable

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

United Kingdom40 participantsStarted 2026-04-20

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Over the age of 18
✓. Non-specific LBP for at least 6 weeks in the past 12 months
✓. Pain 4/10 on a visual analogue scale or more or Oswestry Disability Index over 20%

Exclusion criteria

✕. Serious spinal pathology ("red flags") such as:
✕. Recent spinal surgery or invasive spinal procedures within the past 3 months.
✕. Severe cardiovascular or respiratory disease that prevents safe participation in mild to moderate exercise (e.g., unstable angina, uncontrolled heart failure).
✕. Pregnant women or those less than three months postpartum.
✕. Known allergy to materials used in the belt (e.g., Lycra or related fabrics).
✕. Cognitive impairment that prevents informed consent or ability to follow exercise instructions.
✕. Concurrent participation in another intervention trial that may interfere with the study outcomes.

What they're measuring

Oswestry Disability Index

Timeframe: From enrollment to 3 months after the end of treatment period (8 weeks treatment)

Pain Visual Analogue Scale

Timeframe: From enrollment to 3 months after the end of treatment period (8 weeks treatment)

Trial details

NCT IDNCT07555795

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-20

Contact for this trial

Reneira Seeamber Balaghee

+447496682750 r.seeamber18@imperial.ac.uk

View on ClinicalTrials.gov More Non-specific Low Back Pain trials