Spinal Balance with Wearables - Case-Control
Research type
Research Study
Full title
Measuring Dynamic Spinal Balance with wearable activity trackers. A Case-Control study.
IRAS ID
278083
Contact name
Julian J H Leong
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2020/10/44, UCL Data Protection Registration
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Adolescent Idiopathic Scoliosis (AIS) is typically diagnosed between 10-16 years. Due to the progressive and variable nature of AIS, patients will be clinically and radiographically assessed multiple times per year throughout their adolescence so that progression of the curve can be monitored, treatment decisions can be made and response to treatment or recovery from surgery can be observed. Patient monitoring such as this requires a child to take a lot of time out of school, and evidence suggests an increased lifetime risk of cancer, likely related to the abundance of radiographs taken during a rapid growth phase. A wearable device for use by patients with AIS would help provide additional objective data for the consultant and patient care team. Most notably, it would provide data from a real-life environment over a larger, continuous period, rather than data constrained by the intervals of standard care. If the wearable is accurate and reliable it could provide data from afar, decreasing the number of hospital visits and/or radiographs required.
This first study in a series of 3 will focus on patients with AIS. Their balance will be measured using a gait laboratory and wearable device to validate balance measurements in a clinical population and assess the clinical usefulness of the measure in a clinical and home environment.
Patients with AIS are eligible for this study.
The study will be conducted at the University College London, Institute of Orthopaedics & Musculoskeletal Science, Stanmore, UK & the Royal National Orthopaedic Hospital, Stanmore, UK.
The study will run for approximately 1 year. Participants will have no change to their treatment, but will attend 1 additional appointment for data collection. At data collection appointments participants will perform a series of walking tasks in a gait laboratory and/or whilst wearing a CE-marked wearable device.
REC name
Wales REC 2
REC reference
21/WA/0146
Date of REC Opinion
22 Jun 2021
REC opinion
Further Information Favourable Opinion