Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

NCT02968043 | Unknown DMC

• 1 other identifier: XH-16-041
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Scoliosis Idiopathic Adolescent

Keywords

physiotherapeutic scoliosis specific exercise

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Cobb's Angle at 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.

  up to 6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

control group

ACTIVE COMPARATOR

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.

Other: generalised physiotherapy exercises

intervention group

EXPERIMENTAL

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.

Other: physiotherapeutic scoliosis specific exercises

Interventions

physiotherapeutic scoliosis specific exercises OTHER

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.

intervention group

generalised physiotherapy exercises OTHER

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.

control group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• to 16 years old
• skeletal immaturity with Risser sign of \<3

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Xinhua Hospital Chongming Branch: collaborator
• Shanghai First Rehabilitation Hospital: collaborator
• Shanghai Yangzhi Rehabilitation Hospital: collaborator
• Shanghai Yangpu Daqiao Community Health Service Center: collaborator

Study Sites (2)

Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Xinhua Hospital Chongming Branch

Shanghai, Shanghai Municipality, 202150, China

RECRUITING

Study Officials

• Qing Du, Ph.D

  Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Du, Ph.D

CONTACT

25078999; duqing810@126.com

Xuan Zhou, M.M

CONTACT

25078999; zhouxuanxh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Rehabilitation Department

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 18, 2016
• Study Start: February 13, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)