Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2026
CompletedFirst Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 20, 2027
April 29, 2026
April 1, 2026
1 year
April 21, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Oswestry Disability Index
From enrollment to 3 months after the end of treatment period (8 weeks treatment)
Pain Visual Analogue Scale
From enrollment to 3 months after the end of treatment period (8 weeks treatment)
Secondary Outcomes (3)
EQ-5D-5L
From enrollment to 3 months after the end of treatment period (8 weeks treatment)
MSK-HQ
From enrollment to 3 months after the end of treatment period (8 weeks treatment)
Exercise Adherence
From enrollment to the end of treatment at 8 weeks
Other Outcomes (2)
Qualitative user surveys
From enrollment to the end of treatment at 8 weeks
Strength and Endurance
From enrollment to the end of treatment at 8 weeks.
Study Arms (2)
Exercise with real-time muscle biofeedback
EXPERIMENTALParticipants randomised to the intervention arm will receive a standardised lab session on the use of the MMG-biofeedback belt and mobile application. A physiotherapist or trained researcher will demonstrate how to perform each exercise, correct belt positioning, app navigation, calibration procedures, and how to interpret the real-time muscle activation feedback. Participants will be issued the MMG-biofeedback belt and app after training and will use the system throughout their prescribed home-based exercise sessions for the full eight-week intervention period. Participants are asked to perform the exercise programme (20-30 mins) at least 5 times a week. The app will provide real-time feedback on muscle activation, progress summaries and reminders. Participants are asked to carry on any other treatment as usual. Aside from routine data collection and belt troubleshooting, participants in the control group will not receive additional input from the research team.
Exercise without biofeedback (waitlist control)
NO INTERVENTIONParticipants randomised to the control arm will receive a standardised lab session, whereby core strength and endurance measures are taken. A physiotherapist or trained researcher will demonstrate how to perform each exercise. Participants will be issued with a booklet containing the exercise programme with exercise video links and are asked to perform their prescribed home-based exercise sessions for the full eight-week intervention period. Participants are asked to perform the exercise programme (20-30 mins) at least 5 times a week. No MMG-biofeedback belt will be provided to this group, participants are asked to carry on any other treatment as usual. Aside from routine data collection, participants in the control group will not receive additional input from the research team.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Surrey Physiocollaborator
Study Sites (1)
Imperial College London
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Bentley
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2026
First Posted
April 29, 2026
Study Start
April 20, 2026
Primary Completion (Estimated)
April 20, 2027
Study Completion (Estimated)
April 20, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- De-identified individual participant data (IPD) and supporting documents will be made available following publication of the primary study results. Data will be accessible for up to 5 years after publication. Supporting documents, including the study protocol and statistical analysis plan, may be made available earlier where appropriate.
- Access Criteria
- Access to de-identified IPD and supporting information will be granted to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the study team and subject to approval. Data will be shared under a data sharing agreement to ensure appropriate use and protection of participant confidentiality. Data will be provided in a secure, anonymised format. Proprietary data, including raw sensor signals and algorithms, will not be shared; however, processed or aggregated data sufficient to reproduce study findings may be made available upon request.
De-identified individual participant data (IPD) underlying the results reported in publications will be made available to other researchers upon reasonable request. This will include participant-level data for primary and secondary outcomes (e.g. disability scores, pain scores, adherence metrics), along with relevant baseline characteristics. Raw sensor data (e.g. MMG signals) and proprietary algorithms will not be shared in full due to intellectual property considerations. However, processed or aggregated data derived from these signals may be shared where appropriate to support reproducibility of findings. All shared data will be fully anonymised in accordance with GDPR and institutional data protection policies.