NCT04682379

Brief Summary

This is the first clinical study to examine the spinal and peripheral proprioceptive deficits in longitudinal terms among subjects with adolescent idiopathic scoliosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

December 16, 2020

Last Update Submit

March 28, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Repositioning errors

    The deviation between the position achieved by the subject and the reference position.

    Baseline

  • Repositioning errors

    The deviation between the position achieved by the subject and the reference position.

    One year follow-up

Study Arms (2)

Scoliotic patients with proprioceptive deficits

Study subjects possessed statistically significant differences in testing outcomes of proprioception compared with healthy controls.

Diagnostic Test: Proprioceptive assessment

Scoliotic patients without proprioceptive deficits

Study subjects with similar testing results of proprioception compared with healthy controls.

Diagnostic Test: Proprioceptive assessment

Interventions

1. 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

Scoliotic patients with proprioceptive deficitsScoliotic patients without proprioceptive deficits

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • diagnosis of adolescent idiopathic scoliosis
  • did not receive or failed conservative treatment

You may not qualify if:

  • spinal injury, fracture, or spinal tumour
  • neurological deficit
  • brain or spinal cord abnormality
  • developmental delay
  • psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

Related Publications (3)

  • 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.

    PMID: 34911378BACKGROUND
  • Lau 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.

    PMID: 37203456BACKGROUND
  • Lau 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.

    PMID: 35922635BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Kenneth Cheung

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 23, 2020

Study Start

January 11, 2021

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

April 1, 2024

Record last verified: 2024-01

Locations