NCT03497520

Brief Summary

The purpose of this study is to evaluate the effect of asymmetric spinal stabilization exercise on scoliosis

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 29, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

6.7 years

First QC Date

March 29, 2018

Last Update Submit

April 18, 2024

Conditions

Keywords

surface EMGcobb angleexerciseSpinal Curvatures

Outcome Measures

Primary Outcomes (3)

  • cobb angle

    measure lateral curve of vertebra on spine x-ray AP view

    through study completion, an average of 6 months

  • Apical vertebral rotation

    angle of trunk rotation in Adam's test

    through study completion, an average of 1 year

  • surface electromyography

    surface muscle contraction of bilateral spinal muscle on T7, T12, L3

    through study completion, an average of 6 months

Secondary Outcomes (1)

  • Scoliosis Research Society-22(SRS-22) quastionnaire

    through study completion, an average of 1 year

Study Arms (1)

scoliosis patients

EXPERIMENTAL

scoliosis patients who have cobb angle over 10 degree perform asymmetric spinal stabilization exercise

Behavioral: asymmetric spinal stabilization exercise

Interventions

The patients were educated to strengthening weakness side of spinal muscle, as asymmetric spinal stabilization exercise(ASSE) * before teach ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity * after perform ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity

scoliosis patients

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • who have idiopathic scoliosis, showing at Cobb's angle over 10 degrees on X-ray

You may not qualify if:

  • Patients who underwent spinal surgery
  • Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
  • Patients observed with Cobb's angle less than 10 degrees, over 40 degrees
  • Patients complaining of acute low back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Motor ActivitySpinal Curvatures

Condition Hierarchy (Ancestors)

BehaviorSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Jusuk Ryu, M.D. PhD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 13, 2018

Study Start

March 29, 2018

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations