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Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis

Primary Purpose

Idiopathic Scoliosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Three-dimensionally corrective exercise for scoliosis
Conventional exercise
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 Idiopathic Scoliosis

Eligibility Criteria

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

Inclusion Criteria(meet all the following conditions):

  1. Age between 8-16;
  2. Definitely diagnosed as IS;
  3. Patients with Cobb angle greater than or equal to 10° and less than 45°.

Exclusion Criteria(at least meet one of the following conditions):

  1. Scoliosis caused by congenital, postural, neuromuscular or other diseases (such as neurofibromatosis, Marfan syndrome, bone dysplasia, metabolic or endocrine diseases, etc.);
  2. Patients suffering from mental illness or rheumatic disease;
  3. Patients with insufficient understanding ability to understand and complete the treatment plan;
  4. Patients with exercise contraindications who cannot tolerate exercise therapy;
  5. Patients with poor treatment compliance or refusal to treat;
  6. Patients with a history of rehabilitation or surgery before the first visit;
  7. Patients with apical vertebrae at T7 and above, or patients with mature bones.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Three-dimensionally corrective exercise for scoliosis

Conventional exercise

Arm Description

Experimental group will perform three-dimensionally corrective exercise for scoliosis for a 60-min period for 1-2 times a week under the guidance of physical therapist in an outpatient clinic, and a 40-min period per day under the supervision of the parents at home.For moderate patients, additional brace treatment for more than 22 hours a day.The treatment regimens lasted for 12 months.

Control subjects will perform conventional exercise for a 60-min period for 1-2 times a week under the guidance of physical therapist in an outpatient clinic, and a 40-min period per day under the supervision of the parents at home. For moderate patients, additional brace treatment for more than 22 hours a day.The treatment regimens lasted for 12 months.

Outcomes

Primary Outcome Measures

Change of Cobb angle
It is recommended that curve magnitude of scoliosis is measured using the Cobb method. The Cobb angle will be measured on the standing frontal radiograph according to the Cobb method by the physician specializing in the treatment of scoliosis.

Secondary Outcome Measures

Angle of trunk rotation
The angle of trunk rotation will be measured with a Scoliometer. Patients will be asked to bend forward, and the physician will measure the angle of trunk rotation using the Scoliometer.
Sagittal index
The Sagittal index (SI) is the sum of plumbline distances from C7 and L3. When SI<60mm,it is considered to be flat black; 60-90mm is in the normal range; >90 mm is considered to kyphosis.
Forced vital capacity
Forced vital capacity (FVC) is an established measure of pulmonary function.
Forced expiratory volume in first second
Forced expiratory volume in first second is an established measure of pulmonary function.
Peak oxygen uptake
Peak oxygen uptake is recognised as the best expression of exercise endurance and will be measured by cardiopulmonary exercise testing.
Scoliosis Research Society-22 (SRS-22) questionnaire score
Scoliosis Research Society-22 (SRS-22) questionnaire was designed for patients with scoliosis specially , which consists of 22 items with 5 dimensions: function/activity, pain, self-Image, mental health, and satisfaction with treatment. The higher scores mean a better outcome.

Full Information

First Posted
August 28, 2020
Last Updated
October 9, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04539522
Brief Title
Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis
Official Title
A Prospective Clinical Study on the Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

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

5. Study Description

Brief Summary
Idiopathic scoliosis (AIS) is one of the most prevalent spinal deformity that may progress sharply during growth. It is recommended that the physiotherapeutic scoliosis-specific exercises should be the first step to treat idiopathic scoliosis to prevent/limit progression of the deformity. Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focuses on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional self-correction, balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally corrective exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally corrective exercise intervention on the change of Cobb angle, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life, compared to conventional exercise therapy for patients with mild and moderate AIS. Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be divided into two groups(experimental group or control group) according to their wishes. Subjects in experimental group will perform three-dimensionally corrective exercise for scoliosis (moderate patients combined with a brace) and those in the control group will receive conventional exercise therapy (moderate patients combined with a brace). Blinded assessments at baseline and immediately post 12-month intervention will include radiographic measurement, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life.
Detailed Description
Idiopathic scoliosis (AIS) is one of the most prevalent spinal deformity that may progress sharply during growth. According to the severity of the curve, the major treatment approaches for patient with AIS include exercises, bracing and surgery, to correct, prevent or stop the progression of the deformity.In North America, Scoliosis Research Society (SRS) has been published the standard of care for AIS: patients with curves between 10 and 25° should be observation who are still growing. While in the Europe, the International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) has recommended that the physiotherapeutic scoliosis-specific exercises should be the first step to treat idiopathic scoliosis to prevent/limit progression of the deformity. Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focuses on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional self-correction, balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally corrective exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally corrective exercise intervention on the change of Cobb angle, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life, compared to conventional exercise therapy for patients with mild and moderate AIS. The present study is a single-center prospective non-randomised controlled trial conducted at the department of rehabilitation medicine, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine. The demographic data (height, weight), menarche status for the girls, family history, will be recorded by the physician. Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be assigned by a 1:1 allocation ratio either to the experimental group, in which they will perform three-dimensionally integrated exercise for scoliosis, or the control group, in which they will receive the standard of care with observation according to the Scoliosis Research Society criteria. Blinded assessments at baseline and immediately post 12-month intervention will include radiographic measurement, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Three-dimensionally corrective exercise for scoliosis
Arm Type
Experimental
Arm Description
Experimental group will perform three-dimensionally corrective exercise for scoliosis for a 60-min period for 1-2 times a week under the guidance of physical therapist in an outpatient clinic, and a 40-min period per day under the supervision of the parents at home.For moderate patients, additional brace treatment for more than 22 hours a day.The treatment regimens lasted for 12 months.
Arm Title
Conventional exercise
Arm Type
Active Comparator
Arm Description
Control subjects will perform conventional exercise for a 60-min period for 1-2 times a week under the guidance of physical therapist in an outpatient clinic, and a 40-min period per day under the supervision of the parents at home. For moderate patients, additional brace treatment for more than 22 hours a day.The treatment regimens lasted for 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Three-dimensionally corrective exercise for scoliosis
Intervention Description
Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focus on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional auto-correction(combine with specific breathing mode, isometric training to correct abnormal spinal physiological curvatures in sagittal plane, and accompany with wedge pad to modify humpback, waist asymmetry, pelvic rotation in horizontal. While in coronal plane, longitudinal axial stretching, pelvic adjustments will be conducted to reduce the lateral curvature.), balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient.
Intervention Type
Behavioral
Intervention Name(s)
Conventional exercise
Intervention Description
Conventional exercise consists a series of spine exercises focusing on core strength training.
Primary Outcome Measure Information:
Title
Change of Cobb angle
Description
It is recommended that curve magnitude of scoliosis is measured using the Cobb method. The Cobb angle will be measured on the standing frontal radiograph according to the Cobb method by the physician specializing in the treatment of scoliosis.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Angle of trunk rotation
Description
The angle of trunk rotation will be measured with a Scoliometer. Patients will be asked to bend forward, and the physician will measure the angle of trunk rotation using the Scoliometer.
Time Frame
up to 12 months
Title
Sagittal index
Description
The Sagittal index (SI) is the sum of plumbline distances from C7 and L3. When SI<60mm,it is considered to be flat black; 60-90mm is in the normal range; >90 mm is considered to kyphosis.
Time Frame
up to 12 months
Title
Forced vital capacity
Description
Forced vital capacity (FVC) is an established measure of pulmonary function.
Time Frame
up to 12 months
Title
Forced expiratory volume in first second
Description
Forced expiratory volume in first second is an established measure of pulmonary function.
Time Frame
up to 12 months
Title
Peak oxygen uptake
Description
Peak oxygen uptake is recognised as the best expression of exercise endurance and will be measured by cardiopulmonary exercise testing.
Time Frame
up to 12 months
Title
Scoliosis Research Society-22 (SRS-22) questionnaire score
Description
Scoliosis Research Society-22 (SRS-22) questionnaire was designed for patients with scoliosis specially , which consists of 22 items with 5 dimensions: function/activity, pain, self-Image, mental health, and satisfaction with treatment. The higher scores mean a better outcome.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria(meet all the following conditions): Age between 8-16; Definitely diagnosed as IS; Patients with Cobb angle greater than or equal to 10° and less than 45°. Exclusion Criteria(at least meet one of the following conditions): Scoliosis caused by congenital, postural, neuromuscular or other diseases (such as neurofibromatosis, Marfan syndrome, bone dysplasia, metabolic or endocrine diseases, etc.); Patients suffering from mental illness or rheumatic disease; Patients with insufficient understanding ability to understand and complete the treatment plan; Patients with exercise contraindications who cannot tolerate exercise therapy; Patients with poor treatment compliance or refusal to treat; Patients with a history of rehabilitation or surgery before the first visit; Patients with apical vertebrae at T7 and above, or patients with mature bones.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Du, Ph.D
Phone
+86 021-25078999
Ext
8600
Email
duqing810@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Zhou, M.M
Phone
+86 021-25078999
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,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
+86 021-25078999
Ext
7485
Email
xinhuacru@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35123460
Citation
Zhou X, Li X, Wu Q, Liang J, Guo H, Jin M, Zhu X, Du Q. Three-dimensional corrective exercise therapy for idiopathic scoliosis: study protocol for a prospective non-randomized trial. BMC Musculoskelet Disord. 2022 Feb 5;23(1):118. doi: 10.1186/s12891-022-05057-7.
Results Reference
derived

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Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis

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