NCT04735484

Spinal Balance With Wearables - Case-control

Measuring Dynamic Spinal Balance With Wearable Activity Trackers. A Case Control Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: Female
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Observational case-control study to see if the Margin of Stability and Dynamic Postural Stability (measured using a motion capture gait laboratory and wearable device, respectively) are different in children with Adolescent Idiopathic Scoliosis and matched controls. Participants will walk across level ground and on a treadmill once for data collection and no follow-up is required.

Detailed description

The goal of this observational case-control study is to validate the Margin of Stability (MoS) and Dynamic Postural Stability (DPS) measures using a motion capture gait laboratory and wearable device in patients with Adolescent Idiopathic Scoliosis (AIS). These measures will provide a consultant with objective data about a patient's movement and balance that the consultant and other healthcare professionals can use to infer about their spinal deformity progression or improvement. This research is an early step for working towards providing a distance medicine, non-invasive outcome measure that can be used alongside or in the absence of current clinical measures and radiography. Use of this data could reduce the frequency with which radiographs are required and so reduce the impact of radiation exposure. This wearable device could complement and improve upon existing outcome measures in the treatment of spinal deformity, reduce the need for radiographs and ameliorate the need for distance patient monitoring methods. A motion capture gait laboratory will be used as the gold-standard comparison. A pilot study has been carried out on healthy participants with a simulated spinal deformity in a kinematic gait laboratory and using the wearable device, which showed altered balance in the simulated scoliosis group compared to controls. The aim of this project is to: 1. To see if there's a difference in MoS and DPS between children with AIS and controls, 2. To see if a difference can be detected using motion capture gait analysis and a wearable device, 3. To see how similar results from the wearable device are to the motion capture gait laboratory, 4. To test the ability of the wearable device to measure a scalable difference between radiographic curve magnitude in patients with AIS. Participants will attend one data collection appointment where they will walk across level ground and on a treadmill. No follow-up is required.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	Gait analysis	Collecting movement data whilst participants walk

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-02-03
• Last updated: 2021-02-03