The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis

Neuromuscular Scoliosis Clinical Trial

Official title:

The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012112
• Other study ID #: B-1807-481-005
• Status: Completed
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• 20-45' degrees of cobb's angle in the neuromuscular disease

Exclusion Criteria:

• patient's who had spinal surgery

• less than 20 degree or more than 45 degree of cobb's angle

• acute lumbar pain

Related Conditions & MeSH terms

• Neuromuscular Scoliosis
• Scoliosis

Intervention

Device:
• thoracolumbar brace (Flexpine brace)
Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university bundang hospital	Seongnam-si	Bundang

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change of pain	pain scale checked through the visual analog scale	6months
Secondary	change of pulmonary function	assessed by spirometer of forced vical capacity	6 months
Secondary	change of quality of life	Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire	6 months