Spinal Balance With Wearables - Case-control

NCT ID: NCT04735484

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2022-03-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Case

Participants will attend one data collection appointment wearing form-fitting sports clothing and trainers. Participants will wear infrared markers and wearable devices whilst walking over level ground and on a treadmill. Data will be collected using a motion capture system and the wearable devices themselves. Data collection will take approximately 90 minutes

Gait analysis

Intervention Type: DEVICE

Collecting movement data whilst participants walk

Control

Participants will attend one data collection appointment wearing form-fitting sports clothing and trainers. Participants will wear infrared markers and wearable devices whilst walking over level ground and on a treadmill. Data will be collected using a motion capture system and the wearable devices themselves. Data collection will take approximately 90 minutes

Gait analysis

Intervention Type: DEVICE

Collecting movement data whilst participants walk

Interventions

Gait analysis

Collecting movement data whilst participants walk

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Royal National Orthopaedic Hospital NHS Trust

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Loureiro

Role: PRINCIPAL_INVESTIGATOR

University College, London

Central Contacts

Fraye Watson

Role: CONTACT

fraye.watson.18@ucl.ac.uk

07749350940

Julian Leong

Role: CONTACT

julian@leong.org.uk

Other Identifiers

EDGE132844

Identifier Type: -

Identifier Source: org_study_id