Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:

A Prospective Clinical Study on the Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539522
• Other study ID #: XHEC-SHHDC-2021-009-2
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Qing Du, Ph.D
• Phone: +86 021-25078999
• Email: duqing810[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: September 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Behavioral:
• Three-dimensionally corrective exercise for scoliosis
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.
• Conventional exercise
Conventional exercise consists a series of spine exercises focusing on core strength training.

Locations

Country	Name	City	State
China	Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 months
Secondary	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.	up to 12 months
Secondary	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.	up to 12 months
Secondary	Forced vital capacity	Forced vital capacity (FVC) is an established measure of pulmonary function.	up to 12 months
Secondary	Forced expiratory volume in first second	Forced expiratory volume in first second is an established measure of pulmonary function.	up to 12 months
Secondary	Peak oxygen uptake	Peak oxygen uptake is recognised as the best expression of exercise endurance and will be measured by cardiopulmonary exercise testing.	up to 12 months
Secondary	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.	up to 12 months