Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
MMG-biofeedback belt
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Exercise with real-time muscle biofeedbackExperimental treatment 1 intervention
Group B: Exercise without biofeedback (waitlist control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Oswestry Disability Index
Time frame
From enrollment to 3 months after the end of treatment period (8 weeks treatment)2
Pain Visual Analogue Scale
Time frame
From enrollment to 3 months after the end of treatment period (8 weeks treatment)Secondary outcomes
1
EQ-5D-5L
Time frame
From enrollment to 3 months after the end of treatment period (8 weeks treatment)2
MSK-HQ
Time frame
From enrollment to 3 months after the end of treatment period (8 weeks treatment)3
Exercise Adherence
Time frame
From enrollment to the end of treatment at 8 weeksOther outcomes
1
Qualitative user surveys
Time frame
From enrollment to the end of treatment at 8 weeks2
Strength and Endurance
Maximal Voluntary Contractions (MVCs) in flexion and extension are recorded using the Cybex dynanometer. The peak torque (Nm) is measured during three repetitions of each MVC as a measure of isometric strength. Endurance was measured as the amount of time the participant could hold 50% of their MVC in flexion and extension using the Cybex dynanometer. Endurance measures were also performed using McGill's Torso Muscular Endurance Test Battery (trunk flexor and extensor)/ Biering-Sorenson Test.
Time frame
From enrollment to the end of treatment at 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Surrey Physio
Collaborator
Source ClinicalTrials.gov