Adolescent Idiopathic ScoliosisNCT04735484
Spinal Balance With Wearables - Case-control
An observational study of Adolescent Idiopathic Scoliosis, run by University College, London.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Gait analysis
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
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
Trial locations and contacts
No sites are listed yet.
Julian Leong contact
About this study
Official title: Measuring Dynamic Spinal Balance With Wearable Activity Trackers. A Case Control Study.
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.
Read the 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:
- To see if there's a difference in MoS and DPS between children with AIS and controls,
- To see if a difference can be detected using motion capture gait analysis and a wearable device,
- To see how similar results from the wearable device are to the motion capture gait laboratory,
- 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
- Being tested
- Gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisDevice
Collecting movement data whilst participants walk
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin of stability
Measured: Data collection appointment 1 - approx. 90 minutes
Secondary outcomes (3)
Dynamic Postural Stability
Measured: Data collection appointment 1 - approx. 90 minutes
Correlation between Margin of Stability and radiographic Cobb angle
Measured: Data collection appointment 1 - approx. 90 minutes
Correlation between Dynamic Postural Stability and radiographic Cobb angle
Measured: Data collection appointment 1 - approx. 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study startMay 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Rui Loureiro, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735484
- Sponsor's protocol ID
- EDGE132844
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Dynamic Spinal Balance With Wearable Activity Trackers. A Case Control Study.
- ClinicalTrials.gov ID
- NCT04735484
- Acronym / sponsor ID
- EDGE132844
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Study start
- May 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To see if there's a difference in MoS and DPS between children with AIS and controls,
- To see if a difference can be detected using motion capture gait analysis and a wearable device,
- To see how similar results from the wearable device are to the motion capture gait laboratory,
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Device: Gait analysisParticipants 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 |
| Control | – | Device: Gait analysisParticipants 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysisCollecting movement data whilst participants walk | Device | Case, Control |
Primary outcome
Margin of stability
Time frame: Data collection appointment 1 - approx. 90 minutes
3 secondary outcomes
Dynamic Postural Stability
Time frame: Data collection appointment 1 - approx. 90 minutes
Correlation between Margin of Stability and radiographic Cobb angle
Time frame: Data collection appointment 1 - approx. 90 minutes
Correlation between Dynamic Postural Stability and radiographic Cobb angle
Time frame: Data collection appointment 1 - approx. 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Leong contact
Rui Loureiro principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fraye Watson (07749350940, fraye.watson.18@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin of stability (time frame: Data collection appointment 1 - approx. 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.