NCT04012112

Brief Summary

In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 23, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

June 5, 2019

Last Update Submit

July 21, 2020

Conditions

Neuromuscular Scoliosis

Keywords

braceneuromuscular diseasescoliosis

Outcome Measures

Primary Outcomes (1)

  • change of the scoliosis

    Cobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace

    6months

Secondary Outcomes (3)

  • change of pain

    6months

  • change of pulmonary function

    6 months

  • change of quality of life

    6 months

Study Arms (1)

single-arm trials

EXPERIMENTAL

longitudial study of the thoracolumbar brace in the neuromuscular scoliosis for 6 months

Device: thoracolumbar brace (Flexpine brace)

Interventions

thoracolumbar brace (Flexpine brace)DEVICE

Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month

single-arm trials

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ' degrees of cobb's angle in the neuromuscular disease

You may not qualify if:

  • patient's who had spinal surgery
  • less than 20 degree or more than 45 degree of cobb's angle
  • acute lumbar pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seongnam-si, Bundang, 13364, South Korea

Location

MeSH Terms

Conditions

Neuromuscular DiseasesScoliosis

Condition Hierarchy (Ancestors)

Nervous System DiseasesSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

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

Study Record Dates

First Submitted

June 5, 2019

First Posted

July 9, 2019

Study Start

August 23, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

KR(1)