Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Sponsors

Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator: Xinhua Hospital Chongming Branch
Shanghai First Rehabilitation Hospital
Shanghai Yangzhi Rehabilitation Hospital
Shanghai Yangpu Daqiao Community Health Service Center

Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.

Overall Status Recruiting
Start Date 2017-02-13
Completion Date 2021-12-30
Primary Completion Date 2021-12-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline Cobb's Angle at 6 months up to 6 months
Secondary Outcome
Measure Time Frame
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 Vital Capacity 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 Nondominant Radius Speed of Sound at 6 months up to 6 months
Scores of Scoliosis Research Society-22 Questionnaire up to 6 months
Enrollment 42
Condition
Intervention

Intervention Type: Other

Intervention Name: physiotherapeutic scoliosis specific exercises

Description: Physiotherapeutic scoliosis specific exercises (PSSE) is recommended as a first step in the treatment of AIS to halt curve progression by SOSORT guidelines. The PSSE program will be personalized according to the subject's curves characteristics. The program includes patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. A physiatrist will give a detailed explanation of the aims, importance, methods, and procedure of an intervention to patients and their parents. Each subject will receive guidance from multiple physiotherapists to ensure that the treatment effects are the result of the protocol and not any particular physiotherapists.

Arm Group Label: intervention group

Intervention Type: Other

Intervention Name: generalised physiotherapy exercises

Description: Generalised physiotherapy exercises includes stretching and strengthening activities. Little evidence is in favor of generalised physiotherapy exercises. Each subject will receive guidance from multiple physiotherapists.

Arm Group Label: control group

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

Gender:

All

Minimum Age:

10 Years

Maximum Age:

16 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Qing Du, Ph.D Principal Investigator Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Overall Contact

Last Name: Qing Du, Ph.D

Phone: 25078999

Phone Ext.: 8600

Email: [email protected]

Location
Facility: Status: Contact:
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai, 200092, China Recruiting Guangyu Chen, MD 25078999 7485 [email protected]
Xinhua Hospital Chongming Branch | Shanghai, Shanghai, 202150, China Recruiting Dong Li, MD 18018689957
Location Countries

China

Verification Date

2020-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigator Full Name: Qing Du

Investigator Title: Chief of Rehabilitation Department

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: control group

Type: Active Comparator

Description: Control group will perform generalised physiotherapy exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Generalised physiotherapy exercises consist of stretching and strengthening activities.

Label: intervention group

Type: Experimental

Description: Intervention group will perform physiotherapeutic scoliosis specific exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists with expertise in scoliosis in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Physiotherapeutic scoliosis specific exercises consist of patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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