Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

NCT02968043 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-11-03

No results posted yet for this study

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.

Conditions

  • Scoliosis Idiopathic Adolescent

Interventions

OTHER

physiotherapeutic scoliosis specific exercises

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.

OTHER

generalised physiotherapy exercises

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.

Sponsors & Collaborators

  • Xinhua Hospital Chongming Branch

    collaborator UNKNOWN
  • Shanghai First Rehabilitation Hospital

    collaborator UNKNOWN
  • Shanghai Yangzhi Rehabilitation Hospital

    collaborator UNKNOWN
  • Shanghai Yangpu Daqiao Community Health Service Center

    collaborator UNKNOWN
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Qing Du, Ph.D · Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968043 on ClinicalTrials.gov