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Clinical Trials/NCT02968043
NCT02968043
Unknown
Not Applicable

Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine2 sites in 1 country42 target enrollmentFebruary 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis Idiopathic Adolescent
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
42
Locations
2
Primary Endpoint
Change from Baseline Cobb's Angle at 6 months
Last Updated
5 years ago

Overview

Brief Summary

Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients. There are increasing evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.

Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.

Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.

Detailed Description

Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spinal column, including scoliosis in the coronal plane, fixed rotation of the vertebral body and physiological curvature loss in the sagittal plane. AIS has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients and has been widely used to reduce spinal deformity and halt curve progression. There are two kinds of exercises: generalised physiotherapy exercises and physiotherapeutic scoliosis specific exercise (PSSE). Little evidence is in favor of generalised physiotherapy exercises. There are increasing evidences suggesting that PSSE can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. Thus, the aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai. The AIS patients will be recruited from and investigated at the Xinhua Hospital, Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi Rehabilitation Hospital, and Shanghai Yangpu Daqiao Community Health Service Centre. Prior to inclusion, all subjects will be examined by the physiatrists. The subjects' height, weight, shoulder, chest, back and pelvic asymmetries, and the Adams forward bend test will be evaluated and recorded. The following information will be obtained for all subjects, including demographic data (for example, age and sex), menarche status for the girls, and family history. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study. Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs under the guidance of an experienced physiotherapist with expertise in scoliosis in an outpatient clinic; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will receive the treatment as allocated and will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.

Registry
clinicaltrials.gov
Start Date
February 13, 2017
End Date
December 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qing Du

Chief of Rehabilitation Department

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • patients who are consistent with the diagnosis of adolescent idiopathic scoliosis suggested by Scoliosis Research Society
  • the largest Cobb angle of less than 20 degrees on whole spine posterior-anterior X-ray radiographs in a standing position
  • 10 to 16 years old
  • skeletal immaturity with Risser sign of \<3

Exclusion Criteria

  • previous exercises or brace treatment history
  • previous operation history of spine or lower extremities
  • scoliosis caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or other diseases
  • having contraindications to exercises

Outcomes

Primary Outcomes

Change from Baseline Cobb's Angle at 6 months

Time Frame: up to 6 months

Cobb's angle is the "gold standard" measurement on the frontal plane. The standing full spine posterior-anterior X-ray radiograph will be taken at the initial visit and 6 months later.

Secondary Outcomes

  • Rotation Angle of Apical Vertebral(up to 6 months)
  • Change from Baseline Fall Index at 6 months(up to 6 months)
  • Change from Baseline Forced Expiratory Volume in First Second at 6 months(up to 6 months)
  • Change from Baseline Forced Vital Capacity at 6 months(up to 6 months)
  • Change from Baseline Nondominant Radius Speed of Sound at 6 months(up to 6 months)
  • Scores of Scoliosis Research Society-22 Questionnaire(up to 6 months)

Study Sites (2)

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