Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming
Recruiting now · Not applicable
Conditions studied: Non-specific Low Back Pain, Low Back Pain
In brief
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 facts
- Study ID
- NCT07555795
- Run by
- Imperial College London
- People needed
- 40
- Starts
- 2026-04-20
- Expected to finish
- 2027-04-20
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- Serious spinal pathology ("red flags") such as:
- History of malignancy with new onset back pain suggestive of recurrence.
- Unexplained weight loss, fever, or systemic symptoms.
- Recent significant trauma (e.g., fall from height, road traffic accident).
- Suspected or confirmed spinal infection (e.g., discitis, osteomyelitis).
- Cauda equina symptoms, including urinary retention/incontinence or saddle anaesthesia.
- Progressive neurological deficit (e.g., worsening weakness, loss of reflexes).
- 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.
Where it is running
- Imperial College London — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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