NCT05333796

Brief Summary

The purpose of this study is to evaluate the effect of back muscle activations on idiopathic scoliosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 12, 2022

Last Update Submit

April 18, 2024

Conditions

Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • surface electromyography

    surface muscle contraction of bilateral back muscles * bilateral spinal muscles on T6, T12, L3 * bilateral quadratus lumborum muscles * bilateral iliopsoas muscles

    20 minutes

Study Arms (1)

Healthy children (5 to 12 years old)

EXPERIMENTAL
Behavioral: gait with leg length discrepancy

Interventions

gait with leg length discrepancyBEHAVIORAL

After attaching the surface electromyography(EMG) to bilateral back muscles, participants walk at a comfortable speed. The investigators will evaluate the effects of leg length discrepancy on the back muscle activation during gait.

Healthy children (5 to 12 years old)

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children (5 to 12 years old)

You may not qualify if:

  • Children with leg length discrepancy over 0.5cm
  • Children complaining of acute low back pain
  • Children with spinal scoliosis
  • Children with cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
  • Children who underwent spinal surgery

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

Interventions

Gait

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 19, 2022

Study Start

May 30, 2022

Primary Completion

February 28, 2023

Study Completion

December 12, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

KR(1)