Spinal Balance With Wearables - Case-control

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04735484
• Other study ID #: EDGE132844
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: March 2022

Study information

• Verified date: January 2021
• Source: University College, London
• Contact: Fraye Watson
• Phone: 07749350940
• Email: fraye.watson.18[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 18 Years

Eligibility

Case Inclusion Criteria:

• Diagnosed with Adolescent Idiopathic Scoliosis
• Single, right-sided thoracic, left-sided thoraco-lumbar or left-sided lumbar curve
• <= 1cm leg length discrepancy
• Diagnostic radiographs of curvature within 3 months
• Ability to walk without assistance
• Willing and able to comply with clinical study visit requirements

Control Inclusion Criteria:

• Ability to walk without assistance
• Willing and able to comply with clinical study visit requirements

Case & Control Exclusion Criteria:

• Previous spinal surgery or joint replacement
• Syndromic, neuromuscular or pathologic condition
• Neurological, vestibular, somatosensory or orthopaedic comorbidities
• Pregnancy
• Poor understanding of written and/or spoken English

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Gait analysis
Collecting movement data whilst participants walk

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Royal National Orthopaedic Hospital NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Margin of stability		Data collection appointment 1 - approx. 90 minutes
Secondary	Dynamic Postural Stability		Data collection appointment 1 - approx. 90 minutes
Secondary	Correlation between Margin of Stability and radiographic Cobb angle		Data collection appointment 1 - approx. 90 minutes
Secondary	Correlation between Dynamic Postural Stability and radiographic Cobb angle		Data collection appointment 1 - approx. 90 minutes