Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Patrocinadores

Patrocinador principal: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

Fuente Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Resumen breve

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.

Descripción detallada

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.

Estado general Unknown status
Fecha de inicio February 13, 2017
Fecha de Terminación December 30, 2018
Fecha de finalización primaria December 30, 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change from Baseline Cobb's Angle at 6 months up to 6 months
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 42
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: physiotherapeutic scoliosis specific exercises

Descripción: 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.

Etiqueta de grupo de brazo: intervention group

Tipo de intervención: Other

Nombre de intervención: generalised physiotherapy exercises

Descripción: 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.

Etiqueta de grupo de brazo: control group

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 10 Years

Edad máxima: 16 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Qing Du, Ph.D Principal Investigator Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Contacto general

Apellido: Qing Du, Ph.D

Teléfono: 25078999

Teléfono Ext.: 8600

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto:
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
Ubicacion Paises

China

Fecha de verificación

May 2018

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Nombre completo del investigador: Qing Du

Título del investigador: Chief of Rehabilitation Department

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: control group

Tipo: Active Comparator

Descripción: 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.

Etiqueta: intervention group

Tipo: Experimental

Descripción: 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.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Outcomes Assessor)

Fuente: ClinicalTrials.gov