Adolescent Idiopathic ScoliosisNCT04682379
Adolescent Idiopathic Scoliosis and Proprioceptive Defect
An observational study of Adolescent Idiopathic Scoliosis and Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is the first clinical study to examine the spinal and peripheral proprioceptive deficits in longitudinal terms among subjects with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Idiopathic Scoliosis, Scoliosis
- What is being tested?
- Proprioceptive assessment
- How many people
- 166 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Jan 2021to Dec 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Potential participants will be identified by consecutively screening in the clinics of the speciality outpatient department at the Hospital for all patients with scoliosis
Who may be able to join
- diagnosis of adolescent idiopathic scoliosis
- did not receive or failed conservative treatment
Who cannot join
- spinal injury, fracture, or spinal tumour
- neurological deficit
- brain or spinal cord abnormality
- developmental delay
- psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Proprioceptive Deficits in the Progression of Adolescent Idiopathic Scoliosis
This is the first clinical study to examine the spinal and peripheral proprioceptive deficits in longitudinal terms among subjects with adolescent idiopathic scoliosis.
- Being tested
- Proprioceptive assessment
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive assessmentDiagnostic test
- Trunk flexion-extension repositioning test
- Trunk lateral-flexion repositioning test
- Trunk axial-rotation repositioning test
- Neck rotation repositioning test
- Elbow flexion repositioning test
- Knee extension repositioning test
| Study group | Role | What they receive |
|---|---|---|
| Scoliotic patients with proprioceptive deficits | Study subjects possessed statistically significant differences in testing outcomes of proprioception compared with healthy controls. Receives: Diagnostic Test: Proprioceptive assessment | |
| Scoliotic patients without proprioceptive deficits | Study subjects with similar testing results of proprioception compared with healthy controls. Receives: Diagnostic Test: Proprioceptive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repositioning errors
The deviation between the position achieved by the subject and the reference position.
Measured: Baseline
Repositioning errors
The deviation between the position achieved by the subject and the reference position.
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start11 Jan 2021
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Cheung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682379
- Sponsor's protocol ID
- UW 20-525
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2020
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lau KKL, Law KKP, Kwan KYH, Cheung JPY, Cheung KMC, Wong AYL. Timely Revisit of Proprioceptive Deficits in Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Global Spine J. 2022 Oct;12(8):1852-1861. doi: 10.1177/21925682211066824. Epub 2021 Dec 15.
PubMed 34911378Lau KKL, Law KKP, Kwan KYH, Cheung JPY, Cheung KMC. Proprioception-related gene mutations in relation to the aetiopathogenesis of idiopathic scoliosis: A scoping review. J Orthop Res. 2023 Dec;41(12):2694-2702. doi: 10.1002/jor.25626. Epub 2023 Jun 4.
PubMed 37203456Lau KK, Kwan KY, Cheung JP, Chow W, Law KK, Wong AY, Chow DH, Cheung KM. Reliability of a three-dimensional spinal proprioception assessment for patients with adolescent idiopathic scoliosis. Eur Spine J. 2022 Nov;31(11):3013-3019. doi: 10.1007/s00586-022-07338-0. Epub 2022 Aug 3.
PubMed 35922635
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Proprioceptive Deficits in the Progression of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04682379
- Acronym / sponsor ID
- UW 20-525
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Dec 2020 (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.
This is the first clinical study to examine the spinal and peripheral proprioceptive deficits in longitudinal terms among subjects with adolescent idiopathic scoliosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliotic patients with proprioceptive deficits | – | Diagnostic Test: Proprioceptive assessmentStudy subjects possessed statistically significant differences in testing outcomes of proprioception compared with healthy controls. |
| Scoliotic patients without proprioceptive deficits | – | Diagnostic Test: Proprioceptive assessmentStudy subjects with similar testing results of proprioception compared with healthy controls. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Potential participants will be identified by consecutively screening in the clinics of the speciality outpatient department at the Hospital for all patients with scoliosis
Key inclusion criteria (2 listed)
- diagnosis of adolescent idiopathic scoliosis
- did not receive or failed conservative treatment
Key exclusion criteria (5 listed)
- spinal injury, fracture, or spinal tumour
- neurological deficit
- brain or spinal cord abnormality
- developmental delay
- psychological disorder
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 |
|---|---|---|
| Proprioceptive assessment1. Trunk flexion-extension repositioning test 2. Trunk lateral-flexion repositioning test 3. Trunk axial-rotation repositioning test 4. Neck rotation repositioning test 5. Elbow flexion repositioning test 6. Knee extension repositioning test | Diagnostic test | Scoliotic patients with proprioceptive deficits, Scoliotic patients without proprioceptive deficits |
Primary outcome
Repositioning errors
Time frame: Baseline
The deviation between the position achieved by the subject and the reference position.
Repositioning errors
Time frame: One year follow-up
The deviation between the position achieved by the subject and the reference position.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 34911378Lau KKL, Law KKP, Kwan KYH, Cheung JPY, Cheung KMC, Wong AYL. Timely Revisit of Proprioceptive Deficits in Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Global Spine J. 2022 Oct;12(8):1852-1861. doi: 10.1177/21925682211066824. Epub 2021 Dec 15.
- Background: PubMed 37203456Lau KKL, Law KKP, Kwan KYH, Cheung JPY, Cheung KMC. Proprioception-related gene mutations in relation to the aetiopathogenesis of idiopathic scoliosis: A scoping review. J Orthop Res. 2023 Dec;41(12):2694-2702. doi: 10.1002/jor.25626. Epub 2023 Jun 4.
- Background: PubMed 35922635Lau KK, Kwan KY, Cheung JP, Chow W, Law KK, Wong AY, Chow DH, Cheung KM. Reliability of a three-dimensional spinal proprioception assessment for patients with adolescent idiopathic scoliosis. Eur Spine J. 2022 Nov;31(11):3013-3019. doi: 10.1007/s00586-022-07338-0. Epub 2022 Aug 3.
- 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.
Kenneth Cheung principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis and Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repositioning errors (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682379, which also lists 3 linked publications.
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 1 Apr 2024.