Wearable MMG belt with haptics and games to motivate core exercises

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic non-specific low back pain are randomly assigned to receive the MMG-biofeedback belt plus standard care or standard care alone for eight weeks. The belt uses mechanomyography sensors to measure trunk muscle activity and provides real-time feedback through a smartphone app with haptics and interactive gaming to encourage correct exercise performance. The primary outcome is change in the Oswestry Disability Index (ODI), with secondary outcomes including pain scores and exercise adherence. Outcomes in the two groups are compared to see if real-time muscle activation feedback improves function, pain, and adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. Recent spinal surgery or invasive spinal procedures within the past 3 months.
3. Severe cardiovascular or respiratory disease that prevents safe participation in mild to moderate exercise (e.g., unstable angina, uncontrolled heart failure).
4. Pregnant women or those less than three months postpartum.
5. Known allergy to materials used in the belt (e.g., Lycra or related fabrics).
6. Cognitive impairment that prevents informed consent or ability to follow exercise instructions.
7. Concurrent participation in another intervention trial that may interfere with the study outcomes.

Where it's running

• Imperial College London
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Paul Bentley — Imperial College London
• Study coordinator: Reneira Seeamber Balaghee
• Email: r.seeamber18@imperial.ac.uk
• Phone: +447496682750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.