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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04012112
Enrollment
12
Registered
2019-07-09
Start date
2018-08-23
Completion date
2019-06-30
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Scoliosis

Keywords

brace, neuromuscular disease, scoliosis

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.

Interventions

DEVICEthoracolumbar brace (Flexpine brace)

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change of the scoliosis6monthsCobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace

Secondary

MeasureTime frameDescription
change of pain6monthspain scale checked through the visual analog scale
change of pulmonary function6 monthsassessed by spirometer of forced vical capacity
change of quality of life6 monthsParents assessed the quality of life through the muscular dystrophy spine qusetionnaire

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026