TEST Pilot Study
Research type
Research Study
Full title
Technology Enhanced Shoulder Therapy: A Pilot Study
IRAS ID
229369
Contact name
Luckshman Bavan
Contact email
Sponsor organisation
CTRG
Clinicaltrials.gov Identifier
000000, 000000
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
The aim of this study to assess the feasibility of carrying out a randomised controlled trial (RCT) investigating the clinical benefit of a wearable motion sensors in shoulder rehabilitation. We are currently developing a motion-sensing platform that can accurately detect shoulder activity and deliver objective information on shoulder function. The output metrics will include shoulder range of movement measurements and numeric scores to reflect the quality of shoulder function.
The sensors we will use are commercially available inertial measurement units (IMUs) containing accelerometers and gyroscopes, specifically designed for motion analysis.
This pilot study will involve two groups of patients who will both undergo a shoulder physiotherapy programme for six weeks. The intervention group will undergo self-directed treatment supported with the motion platform, through which they will receive near real-time feedback to help improve exercise performance and highlight changes in compliance and progress. The control group will be referred to the physiotherapy department for treatment as per routine practice.
We will present summary statistics and completeness of outcome data collected at baseline, 6 and 12 weeks. Outcomes will include the Oxford Shoulder Score (questionnaire), the need for surgery and functional scores produced from the motion platform. We will report on rates on enrollment, attrition and adherence to the protocol.
We also plan to collect information on treatment costs incurred to assess the feasibility of performing a formal health economic evaluation.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1739
Date of REC Opinion
11 Oct 2018
REC opinion
Favourable Opinion