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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-20 with a primary completion date of 2027-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Paul Bentley
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT07555795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-specific Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07555795 currently recruiting?
Yes, NCT07555795 is actively recruiting participants. Contact the research team at r.seeamber18@imperial.ac.uk for enrollment information.
Where is the NCT07555795 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07555795 clinical trial?
NCT07555795 is sponsored by Imperial College London. The principal investigator is Paul Bentley at Imperial College London. The trial plans to enroll 40 participants.