NCT07555795 Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming
| NCT ID | NCT07555795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Non-specific Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2027-04-20 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 thre