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

NCT07555795 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Non-specific Low Back Pain
  • Low Back Pain

Interventions

DEVICE

MMG-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.

Sponsors & Collaborators

  • Surrey Physio

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Principal Investigators

  • Paul Bentley · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-04-20
Completion
2027-04-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555795 on ClinicalTrials.gov