Spinal Balance With Wearables - Case-control

NCT04735484 | Unknown

• 1 other identifier: EDGE132844
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Margin of stability

  Data collection appointment 1 - approx. 90 minutes

Secondary Outcomes (3)

• Dynamic Postural Stability

  Data collection appointment 1 - approx. 90 minutes

• Correlation between Margin of Stability and radiographic Cobb angle

  Data collection appointment 1 - approx. 90 minutes

• Correlation between Dynamic Postural Stability and radiographic Cobb angle

  Data collection appointment 1 - approx. 90 minutes

Study Arms (2)

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

Device: Gait analysis

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

Device: Gait analysis

Interventions

Gait analysis DEVICE

Collecting movement data whilst participants walk

Case; Control

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient records will be accessed by a member of the clinical care team with legitimate access to patient records and who is independent to the research team to identify eligible patients as 'Case' participants. These patients and their parents will be approached with a letter asking them to contact the researcher if they are interested in participating. Additionally, recruitment posters will be displayed in the RNOH outpatient and RNOH orthotics departments. For 'Control' participants, with permission from the participating schools and colleges, a letter will be sent to parents of children aged 10-18 at local schools and colleges requesting they volunteer for this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Royal National Orthopaedic Hospital NHS Trust: collaborator

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Rui Loureiro

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fraye Watson

CONTACT

07749350940; fraye.watson.18@ucl.ac.uk

Julian Leong

CONTACT

julian@leong.org.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: May 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 3, 2021

Record last verified: 2021-01