RecruitingNot ApplicableNCT07555795

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

Sponsor

Imperial College London

Enrollment

40 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Low Back Pain Non specific low back pain

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria13

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).
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).
Pregnant women or those less than three months postpartum.
Known allergy to materials used in the belt (e.g., Lycra or related fabrics).
Cognitive impairment that prevents informed consent or ability to follow exercise instructions.
Concurrent participation in another intervention trial that may interfere with the study outcomes.

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Interventions

DEVICEMMG-biofeedback belt

The intervention consists of a wearable belt incorporating mechanomyography (MMG) sensors to detect muscle activity in the abdominal and lower back regions, paired with a mobile application that provides real-time visual feedback on core muscle activation during exercise. The system is designed to guide users in engaging the correct muscles, improve exercise performance, and support adherence to a prescribed exercise programme during both supervised and home-based sessions.