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Trial record 3 of 23 for:    Recruiting Studies | Adolescent Scoliosis

Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT02968043
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Xinhua Hospital Chongming Branch
Shanghai First Rehabilitation Hospital
Shanghai Yangzhi Rehabilitation Hospital
Shanghai Yangpu Daqiao Community Health Service Center
Information provided by (Responsible Party):
Qing Du, 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.


Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Adolescent Other: physiotherapeutic scoliosis specific exercises Other: generalised physiotherapy exercises Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control group
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
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.

Experimental: intervention group
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
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.




Primary Outcome Measures :
  1. Change from Baseline Cobb's Angle at 6 months [ Time Frame: up to 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 :
  1. Rotation Angle of Apical Vertebral [ Time Frame: up to 6 months ]
    Rotation angle of apical vertebral will be measured by Nash Moe rotation at the initial visit and 6 months later.

  2. Change from Baseline Fall Index at 6 months [ Time Frame: up to 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.

  3. Change from Baseline Forced Vital Capacity at 6 months [ Time Frame: up to 6 months ]
    Pulmonary function test will be tested at the initial visit and 6 months later. Forced vital capacity will be measured.

  4. Change from Baseline Forced Expiratory Volume in First Second at 6 months [ Time Frame: up to 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.

  5. Change from Baseline Nondominant Radius Speed of Sound at 6 months [ Time Frame: up to 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.

  6. Scores of Scoliosis Research Society-22 Questionnaire [ Time Frame: up to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968043


Contacts
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Contact: Qing Du, Ph.D 25078999 ext 8600 duqing810@126.com
Contact: Xuan Zhou, M.M 25078999 ext 8609 zhouxuanxh@163.com

Locations
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China, Shanghai
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Guangyu Chen, MD    25078999 ext 7485    xinhuacru@163.com   
Xinhua Hospital Chongming Branch Recruiting
Shanghai, Shanghai, China, 202150
Contact: Dong Li, MD    18018689957      
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xinhua Hospital Chongming Branch
Shanghai First Rehabilitation Hospital
Shanghai Yangzhi Rehabilitation Hospital
Shanghai Yangpu Daqiao Community Health Service Center
Investigators
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Principal Investigator: Qing Du, Ph.D Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

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Responsible Party: Qing Du, Chief of Rehabilitation Department, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02968043     History of Changes
Other Study ID Numbers: XH-16-041
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qing Du, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
physiotherapeutic scoliosis specific exercise

Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases