Motivating core-muscle exercises with wearable sensors, haptics and interactive gaming
| ISRCTN | ISRCTN12188385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12188385 |
| ClinicalTrials.gov (NCT) | NCT07555795 |
| Sponsor | Imperial College London |
| Funders | UK Research and Innovation, Medical Research Council |
- Submission date
- 10/06/2026
- Registration date
- 12/06/2026
- Last edited
- 12/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Low back pain is a common problem that can affect daily life and work. Exercise can help, but people do not always perform the exercises correctly or keep up with them. This study is testing a wearable belt that measures muscle activity and gives real-time feedback through a mobile app. The aim is to find out if using this belt alongside standard care can reduce pain, improve movement and daily function, and help people stick to their exercise programme compared with standard care alone.
Who can participate?
Adults aged 18 years or older who have had non-specific low back pain for at least 6 weeks in the past 12 months may take part. Participants must have a moderate level of pain or disability. People cannot take part if they have serious spinal conditions, recent spinal surgery, certain serious health problems, are pregnant or recently gave birth, or cannot safely do exercise.
What does the study involve?
Participants are randomly placed into one of two groups. Both groups complete a home-based core muscle exercise programme lasting 8 weeks, doing 20 to 30 minutes of exercise at least 5 times per week. One group uses a wearable biofeedback belt and mobile app during exercise to guide muscle use. The other group follows the same exercises using a booklet and videos but without the belt. All participants attend an initial session to learn the exercises. They complete questionnaires about pain, daily function and quality of life at the start, after 8 weeks, and again 3 months later. Researchers also monitor how well participants follow the exercise programme.
What are the possible benefits and risks of participating?
Participants may benefit from improved pain, better movement, and greater confidence in doing their exercises. The wearable system may also help them stay motivated. Risks are likely to be low but may include mild discomfort from exercise or irritation from wearing the belt. As with any exercise programme, there is a small risk of strain or injury.
Where is the study run from?
The study is run from Imperial College London, with additional participation at Surrey Physio Group in Mitcham, England.
When is the study starting and how long is it expected to run for?
April 2026 to April 2027.
Who is funding the study?
UK Research and Innovation
Medical Research Council
Who is the main contact?
Dr Paul Bentley, p.bentley@imperial.ac.uk
Contact information
Principal investigator
10L21, Charing Cross Hospital, Charing Cross Campus
London
W6 8RP
United Kingdom
 ORCID ID |
0000-0001-9645-1196 |
|---|---|
| Phone | +44 20 3311 1194 |
| p.bentley@imperial.ac.uk |
Scientific, Public
10L21, Charing Cross Hospital, Charing Cross Campus
London
W6 8RP
United Kingdom
| Phone | +44 7496682750 |
|---|---|
| rs4318@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Crossover |
| Purpose | Prevention, Treatment |
| Participant information sheet | 49686 Bentley_PIS_BackStudy v10.0 23Feb2026.pdf |
| Scientific title | A randomised controlled trial evaluating the effects of a wearable biofeedback belt for home exercise therapy + standard treatment compared with standard treatment alone on pain, disability and exercise adherence in adults with chronic low back pain |
| Study objectives | |
| Ethics approval(s) |
Approved 11/03/2026, ICREC (Research Office, Level 1, Mediaworks Building, 191 Wood Lane, London, W12 7FP, United Kingdom; +44 (0)20 7594 9456; rgitcoordinator@imperial.ac.uk), ref: 19IC5674 |
| Health condition(s) or problem(s) studied | Prevention and treatment of chronic low back pain |
| Intervention | Experimental : Exercise with real-time muscle biofeedback 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. Participants will be randomised in a 1:1 ratio to either the intervention group (smartbelt plus conventional care) or control group (conventional care alone). Randomisation will be performed using a computer-generated randomisation sequence created by an independent researcher not involved in outcome assessment. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared in advance. Following completion of baseline assessments, participants will be allocated to their assigned group according to the next envelope in sequence. Protocol: Participants 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. No Intervention : Exercise without biofeedback (waitlist control) Participants 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. Follow up for 3 months in both groups. |
| Intervention type | Device |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | UPPITT: MMG-biofeedback belt |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 20/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Over the age of 18 years 2. Non-specific LBP for at least 6 weeks in the past 12 months 3. Pain 4/10 on a visual analogue scale or more or Oswestry Disability Index over 20% |
| Key exclusion criteria | 1. Serious spinal pathology (red flags) such as 1.1 history of malignancy with new onset back pain suggestive of recurrence 1.2 unexplained weight loss, fever, or systemic symptoms 1.3 recent significant trauma (e.g., fall from height, road traffic accident) 1.4 suspected or confirmed spinal infection (e.g., discitis, osteomyelitis) 1.5 cauda equina symptoms, including urinary retention or incontinence or saddle anaesthesia 1.6 progressive neurological deficit (e.g., worsening weakness, loss of reflexes) 2. Recent spinal surgery or invasive spinal procedures within the past 3 months 3. Severe cardiovascular or respiratory disease that prevents safe participation in mild to moderate exercise (e.g., unstable angina, uncontrolled heart failure) 4. Pregnant women or those less than 3 months postpartum 5. Known allergy to materials used in the belt (e.g., lycra or related fabrics) 6. Cognitive impairment that prevents informed consent or ability to follow exercise instructions 7. Concurrent participation in another intervention trial that may interfere with the study outcomes |
| Date of first enrolment | 20/04/2026 |
| Date of final enrolment | 20/11/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
80 Wood Lane
London
W12 7TA
England
Mitcham
CR4 4BG
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 10.0 | 23/02/2026 | 12/06/2026 | No | Yes |
Additional files
- 49686 Bentley_PIS_BackStudy v10.0 23Feb2026.pdf
- Participant information sheet
Editorial Notes
10/06/2026: Trial's existence confirmed by Imperial College.
