RecruitingDevice study
Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming
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.