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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04012112
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Scoliosis	Device: thoracolumbar brace (Flexpine brace)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study
• Actual Study Start Date: Aug 23, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single-arm trials longitudial study of the thoracolumbar brace in the neuromuscular scoliosis for 6 months	Device: thoracolumbar brace (Flexpine brace); Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month

Outcome Measures

Primary Outcome Measures

1. change of the scoliosis [6months]

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

Secondary Outcome Measures

1. change of pain [6months]

   pain scale checked through the visual analog scale

2. change of pulmonary function [6 months]

   assessed by spirometer of forced vical capacity

3. change of quality of life [6 months]

   Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul national university bundang hospital	Seongnam-si	Bundang	Korea, Republic of	13364

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ju Seok Ryu, associate professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04012112
• Other Study ID Numbers: B-1807-481-005
• First Posted: Jul 9, 2019
• Last Update Posted: Jul 22, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ju Seok Ryu, associate professor, Seoul National University Hospital: brace; neuromuscular disease; scoliosis
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of Jul 22, 2020