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Spinal Balance With Wearables - Case-control

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735484
Enrollment
24
Registered
2021-02-03
Start date
2021-05-31
Completion date
2022-03-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

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.

Interventions

DEVICEGait analysis

Collecting movement data whilst participants walk

Sponsors

Royal National Orthopaedic Hospital NHS Trust
CollaboratorOTHER
University College, London
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Margin of stabilityData collection appointment 1 - approx. 90 minutes

Secondary

MeasureTime frame
Dynamic Postural StabilityData collection appointment 1 - approx. 90 minutes
Correlation between Margin of Stability and radiographic Cobb angleData collection appointment 1 - approx. 90 minutes
Correlation between Dynamic Postural Stability and radiographic Cobb angleData collection appointment 1 - approx. 90 minutes

Contacts

Primary ContactFraye Watson
fraye.watson.18@ucl.ac.uk07749350940
Backup ContactJulian Leong
julian@leong.org.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026