Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis
Primary Purpose
Scoliosis,Idiopathic,Adolescent
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
observation
three-dimensionally integrated exercise for scoliosis
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis,Idiopathic,Adolescent
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of adolescent idiopathic scoliosis;
- Age from 10 to 16 years;
- A Cobb angle of 10 to 20 degree;
- A Risser sign of 0-3;
- No other treatment which might affect scoliosis.
Exclusion Criteria:
- Non-idiopathic scoliosis, which caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or other diseases;
- Accompanying mental problems, neurological-muscular or rheumatic diseases;
- Previous operation history of spine or lower extremities;
- Previous exercises or brace treatment history;
- Having contraindications to exercise.
Sites / Locations
- Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
Control subjects will receive observation for 6 months.
Experimental group will perform three-dimensionally integrated 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 20-min period per day under the supervision of the parents at home.The treatment regimens lasted for 6 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.
SRS-22 dimensions scores
SRS-22 questionnaire is 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.
Full Information
NCT ID
NCT03427970
First Posted
January 28, 2018
Last Updated
October 21, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03427970
Brief Title
Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis
Official Title
Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 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
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) 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 integrated exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, and consists of patient education, 3-dimension self-correction, stabilization of the corrected posture and training activity of daily living, combined with neuro-motor control, proprioceptive training, balance training, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally integrated exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally integrated exercise intervention on the change of Cobb angle, angle of trunk rotation(ATR), sagittal profile, and quality of life, compared to standard care for patients with mild AIS.
Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio by computer 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 6-month intervention will include radiographic measurement, trunk rotation, sagittal profile and health related quality-of-life.
Detailed Description
Adolescent 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 integrated exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, and consists of patient education, 3-dimension self-correction, stabilization of the corrected posture and training activity of daily living, combined with neuro-motor control, proprioceptive training, balance training, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally integrated exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally integrated exercise intervention on the change of Cobb angle, angle of trunk rotation(ATR), sagittal profile, and quality of life, compared to standard care for patients with mild AIS.
The present study is a single-center prospective 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 randomized by a 1:1 allocation ratio by computer 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 6-month intervention will include radiographic measurement, trunk rotation, sagittal profile 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
Scoliosis,Idiopathic,Adolescent
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 subjects will receive observation for 6 months.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Experimental group will perform three-dimensionally integrated 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 20-min period per day under the supervision of the parents at home.The treatment regimens lasted for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
observation
Intervention Description
Control group will receive the standard of care according to the Scoliosis Research Society criteria: observation for patients with curves between 10°- 25°.
Intervention Type
Behavioral
Intervention Name(s)
three-dimensionally integrated exercise for scoliosis
Intervention Description
Experimental group will receive a modified physiotherapeutic scoliosis specific exercises --the three-dimensionally integrated exercise for scoliosis program, which include auto-correction in 3D, postural correction, breathing training, resistance training, muscle fascia releasing, functional activities, balance training, core stability training, proprioceptive input exercises and patient education. Auto-correction exercise in 3D will 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.
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 6 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 6 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 6 months
Title
SRS-22 dimensions scores
Description
SRS-22 questionnaire is 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.
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:
A diagnosis of adolescent idiopathic scoliosis;
Age from 10 to 16 years;
A Cobb angle of 10 to 20 degree;
A Risser sign of 0-3;
No other treatment which might affect scoliosis.
Exclusion Criteria:
Non-idiopathic scoliosis, which caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or other diseases;
Accompanying mental problems, neurological-muscular or rheumatic diseases;
Previous operation history of spine or lower extremities;
Previous exercises or brace treatment history;
Having contraindications to exercise.
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
30201050
Citation
Liang J, Zhou X, Chen N, Li X, Yu H, Yang Y, Song Y, Du Q. Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial. Trials. 2018 Sep 10;19(1):485. doi: 10.1186/s13063-018-2834-x.
Results Reference
derived
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Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis
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