Scoliosis,Idiopathic,AdolescentNCT03427970
Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis
A study testing observation and three-dimensionally integrated exercise for scoliosis in people with Scoliosis,Idiopathic,Adolescent, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Scoliosis,Idiopathic,Adolescent
- What is being tested?
- observation and three-dimensionally integrated exercise for scoliosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
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.
Read the 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.
- Conditions
- Scoliosis,Idiopathic,Adolescent
- Being tested
- observation, three-dimensionally integrated exercise for scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationBehavioural
Control group will receive the standard of care according to the Scoliosis Research Society criteria: observation for patients with curves between 10°- 25°.
three-dimensionally integrated exercise for scoliosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control subjects will receive observation for 6 months. Receives: Behavioral: observation |
| experimental group | Experimental | 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. Receives: Behavioral: three-dimensionally integrated exercise for scoliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (3)
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start25 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis,Idiopathic,AdolescentStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Du, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Qing Du, Ph.D, Principal investigator, Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427970
- Sponsor's protocol ID
- XH-18-004
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2018
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30201050
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03427970
- Acronym / sponsor ID
- XH-18-004
- Conditions
- Scoliosis,Idiopathic,Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: observationControl subjects will receive observation for 6 months. |
| experimental group | Experimental | Behavioral: three-dimensionally integrated exercise for scoliosisExperimental 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationControl group will receive the standard of care according to the Scoliosis Research Society criteria: observation for patients with curves between 10°- 25°. | Behavioural | control group |
| three-dimensionally integrated exercise for scoliosisExperimental 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. | Behavioural | experimental group |
Primary outcome
Change of Cobb angle
Time frame: up to 6 months
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.
3 secondary outcomes
Angle of trunk rotation
Time frame: up to 6 months
Sagittal index
Time frame: up to 6 months
SRS-22 dimensions scores
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Derived from this study: PubMed 30201050Liang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Du, Ph.D principal investigator
Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing observation and three-dimensionally integrated exercise for scoliosis in people with Scoliosis,Idiopathic,Adolescent, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cobb angle (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.