Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming (NCT07555795) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oswestry Disability Index
Timeframe: From enrollment to 3 months after the end of treatment period (8 weeks treatment)
2
Pain Visual Analogue Scale
Timeframe: From enrollment to 3 months after the end of treatment period (8 weeks treatment)