Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)

• Sponsor: Ju Seok Ryu (Other)
• Overall Status: Completed
• CT.gov ID: NCT03675984
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

There has been much effort in recent years to better understand the causes of idiopathic scoliosis (IS). Some studies suggested muscle imbalance as a cause of scoliosis based on asymmetric muscular activation. Surface electromyography can evaluate asymmetrical muscular weakness. Therefore, the peak amplitude values can be used to compare the side to side differences in paraspinal muscles. From these findings the investigators improve the exercise method of IS according to muscle weakness and curve pattern.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Scoliosis	Behavioral: asymmetrical stabilization exercise	N/A

Detailed Description

Design: Prospective study Setting: hospital rehabilitation department the investigators will check the muscular activation at bilateral paraspinal muscles with surface electromyography and curve type with simple radiography.

Intervention: After that the investigators educate asymmetrical stabilization exercise according to muscle weakness and curve pattern.

Main outcome measures: Cobb angle

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Annual evaluation after educating asymmetrical stabilization exercise. Cohort study.Annual evaluation after educating asymmetrical stabilization exercise. Cohort study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
• Actual Study Start Date: Dec 22, 2016
• Actual Primary Completion Date: Nov 7, 2017
• Actual Study Completion Date: Nov 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: asymmetrical stabilization exercise group 'asymmetrical stabilization exercise' patient learn asymmetrical stabilization exercise according to the asymmetrical paraspinal muscles weakness and curve type	Behavioral: asymmetrical stabilization exercise; Exercise is combined to form an appropriate combination of motion (Side-lying, Bird-dog, Prone arm lift, Prone leg lift) according to the curve pattern and muscle weakness of each patient's.

Outcome Measures

Primary Outcome Measures

1. Cobb angle [through study completion, an average of 6 months]

   the angle of curvature be measured by drawing lines parallel to the upper border of the upper vertebral body and the lower border of the lowest vertebra of the structural curve on plain radiography

Secondary Outcome Measures

1. Scoliosis Research Society-22(SRS-22) [through study completion, an average of 6 months]

   questionnaire for evaluating quality of life in patients with idiopathic scoliosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• X-ray shows a cobb angle of 10 degrees or higher.

• Patients 8 and older.

Exclusion Criteria:

• Patients with spinal surgery

• Patients with scoliosis caused by cerebral palsy, muscle paralysis, polio, congenital spinal cord abnormalities, etc.

• Cobb angle less than 10 degrees and more than 40 degrees

• Patients with acute back pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Kyungji-do	Korea, Republic of	13620

Sponsors and Collaborators

• Ju Seok Ryu

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: NCT03675984
• Other Study ID Numbers: B-1701/378-103
• First Posted: Sep 18, 2018
• Last Update Posted: Jul 22, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: surface EMG, cobb angle, exercise, Spinal Curvatures
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of Jul 22, 2020