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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675984
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ju Seok Ryu, Seoul National University Hospital

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : December 22, 2016
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cobb angle [ Time Frame: 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) [ Time Frame: through study completion, an average of 6 months ]
    questionnaire for evaluating quality of life in patients with idiopathic scoliosis



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675984


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Kyungji-do, Korea, Republic of, 13620
Sponsors and Collaborators
Ju Seok Ryu
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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: September 18, 2018    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ju Seok Ryu, Seoul National University Hospital:
surface EMG, cobb angle, exercise, Spinal Curvatures
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases