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Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis Idiopathic Adolescent

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
physiotherapeutic scoliosis specific exercises
generalised physiotherapy exercises
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic Adolescent focused on measuring physiotherapeutic scoliosis specific exercise

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Xinhua Hospital Chongming BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

intervention group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rotation Angle of Apical Vertebral
Rotation angle of apical vertebral will be measured by Nash Moe rotation at the initial visit and 6 months later.
Change from Baseline Fall Index at 6 months
Static balance test will be performed at the initial visit and 6 months later. Fall index will be caculated. Fall index scores from 0 to 100. The higher the fall index the higher the risk of fall.
Change from Baseline Forced Vital Capacity at 6 months
Pulmonary function test will be tested at the initial visit and 6 months later. Forced vital capacity will be measured.
Change from Baseline Forced Expiratory Volume in First Second at 6 months
Pulmonary function test will be tested at the initial visit and 6 months later. Forced expiratory volume in first second will be measured.
Change from Baseline Nondominant Radius Speed of Sound at 6 months
Bone quality will be measured using a quantitative ultrasound machine (Omnisense 7000P, Sunlight Medical Inc, Israel) at the initial visit and 6 months later. The quantitative ultrasound method can measure speed of sound (SOS) at the distal 1/3 of the radius by axial transmission. The measurement site is defined as the distal 1/3 of the radius. The mean of three measurements of the radius SOS is used for analysis.
Scores of Scoliosis Research Society-22 Questionnaire
Scoliosis Research Society-22 questionnaire (SRS-22) scores will be evaluated using the Chinese version of SRS-22 at the initial visit and 6 months later. All subjects will be required to complete SRS-22 independently. SRS-22 is a simple form of questionnaire to assess the HRQoL of AIS patients. It consists of 22 questions in 5 domains including functional activity, pain, self-image, psychological heath and satisfaction to treatment. Each question scores from 1 point (the lowest) to 5 (the highest). Each domain scores from 5 points to 25 points except for satisfaction to the treatment, which scores from 2 points to 10 points. Each domain is expressed as a mean value: the higher the score the better the outcome.

Full Information

First Posted
November 11, 2016
Last Updated
November 1, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi Rehabilitation Hospital, Shanghai Yangpu Daqiao Community Health Service Center
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1. Study Identification

Unique Protocol Identification Number
NCT02968043
Brief Title
Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
Official Title
Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi Rehabilitation Hospital, Shanghai Yangpu Daqiao Community Health Service Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic Adolescent
Keywords
physiotherapeutic scoliosis specific exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm 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.
Arm Title
intervention group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
physiotherapeutic scoliosis specific exercises
Intervention 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.
Intervention Type
Other
Intervention Name(s)
generalised physiotherapy exercises
Intervention 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.
Primary Outcome Measure Information:
Title
Change from Baseline Cobb's Angle at 6 months
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Rotation Angle of Apical Vertebral
Description
Rotation angle of apical vertebral will be measured by Nash Moe rotation at the initial visit and 6 months later.
Time Frame
up to 6 months
Title
Change from Baseline Fall Index at 6 months
Description
Static balance test will be performed at the initial visit and 6 months later. Fall index will be caculated. Fall index scores from 0 to 100. The higher the fall index the higher the risk of fall.
Time Frame
up to 6 months
Title
Change from Baseline Forced Vital Capacity at 6 months
Description
Pulmonary function test will be tested at the initial visit and 6 months later. Forced vital capacity will be measured.
Time Frame
up to 6 months
Title
Change from Baseline Forced Expiratory Volume in First Second at 6 months
Description
Pulmonary function test will be tested at the initial visit and 6 months later. Forced expiratory volume in first second will be measured.
Time Frame
up to 6 months
Title
Change from Baseline Nondominant Radius Speed of Sound at 6 months
Description
Bone quality will be measured using a quantitative ultrasound machine (Omnisense 7000P, Sunlight Medical Inc, Israel) at the initial visit and 6 months later. The quantitative ultrasound method can measure speed of sound (SOS) at the distal 1/3 of the radius by axial transmission. The measurement site is defined as the distal 1/3 of the radius. The mean of three measurements of the radius SOS is used for analysis.
Time Frame
up to 6 months
Title
Scores of Scoliosis Research Society-22 Questionnaire
Description
Scoliosis Research Society-22 questionnaire (SRS-22) scores will be evaluated using the Chinese version of SRS-22 at the initial visit and 6 months later. All subjects will be required to complete SRS-22 independently. SRS-22 is a simple form of questionnaire to assess the HRQoL of AIS patients. It consists of 22 questions in 5 domains including functional activity, pain, self-image, psychological heath and satisfaction to treatment. Each question scores from 1 point (the lowest) to 5 (the highest). Each domain scores from 5 points to 25 points except for satisfaction to the treatment, which scores from 2 points to 10 points. Each domain is expressed as a mean value: the higher the score the better the outcome.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Du, Ph.D
Phone
25078999
Ext
8600
Email
duqing810@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Zhou, M.M
Phone
25078999
Ext
8609
Email
zhouxuanxh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Du, Ph.D
Organizational Affiliation
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu Chen, MD
Phone
25078999
Ext
7485
Email
xinhuacru@163.com
Facility Name
Xinhua Hospital Chongming Branch
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
202150
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Li, MD
Phone
18018689957

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

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