NCT03675984

Brief Summary

There has been much effort in recent years to better understand the causes of idiopathic scoliosis (IS). Some studies suggested muscle imbalance as a cause of scoliosis based on asymmetric muscular activation. Surface electromyography can evaluate asymmetrical muscular weakness. Therefore, the peak amplitude values can be used to compare the side to side differences in paraspinal muscles. From these findings the investigators improve the exercise method of IS according to muscle weakness and curve pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

September 10, 2018

Last Update Submit

July 21, 2020

Conditions

Keywords

surface EMG, cobb angle, exercise, Spinal Curvatures

Outcome Measures

Primary Outcomes (1)

  • Cobb angle

    the angle of curvature be measured by drawing lines parallel to the upper border of the upper vertebral body and the lower border of the lowest vertebra of the structural curve on plain radiography

    through study completion, an average of 6 months

Secondary Outcomes (1)

  • Scoliosis Research Society-22(SRS-22)

    through study completion, an average of 6 months

Study Arms (1)

asymmetrical stabilization exercise group

EXPERIMENTAL

'asymmetrical stabilization exercise' patient learn asymmetrical stabilization exercise according to the asymmetrical paraspinal muscles weakness and curve type

Behavioral: asymmetrical stabilization exercise

Interventions

Exercise is combined to form an appropriate combination of motion (Side-lying, Bird-dog, Prone arm lift, Prone leg lift) according to the curve pattern and muscle weakness of each patient's.

asymmetrical stabilization exercise group

Eligibility Criteria

Age8 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • X-ray shows a cobb angle of 10 degrees or higher.
  • Patients 8 and older.

You may not qualify if:

  • Patients with spinal surgery
  • Patients with scoliosis caused by cerebral palsy, muscle paralysis, polio, congenital spinal cord abnormalities, etc.
  • Cobb angle less than 10 degrees and more than 40 degrees
  • Patients with acute back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyungji-do, 13620, South Korea

Location

MeSH Terms

Conditions

Motor ActivitySpinal Curvatures

Condition Hierarchy (Ancestors)

BehaviorSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Annual evaluation after educating asymmetrical stabilization exercise. Cohort study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 18, 2018

Study Start

December 22, 2016

Primary Completion

November 7, 2017

Study Completion

November 7, 2017

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Locations