Idiopathic ScoliosisNCT07109037
Clinical Study on the Improvement of Adult Idiopathic Scoliosis by Sling Exercise Therapy Training Combined With Conventional Exercise Therapy
A study testing Conventional exercise therapy and Suspension training and conventional exercise therapy in people with Idiopathic Scoliosis and Adult, run by Southwest Medical University at 1 site in China.
Trial summary
This study aims to compare the effects of suspension exercise therapy combined with conventional exercise therapy and conventional exercise therapy alone on pain, Cobb angle, functional impairment, and quality of life in adult patients with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Scoliosis, Adult
- What is being tested?
- Conventional exercise therapy and Suspension training and conventional exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 27 Jun 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the anteroposterior and lateral X-ray films of the spine in the standing position, the Cobb angle is ≥10° and <40°
- The age ranges from 18 to 75 years old
- No previous history of surgery
- Not wearing a corrective brace
Who cannot join
- Having mental illnesses
- Having severe cognitive and communication disorders
- Having severe cardiopulmonary dysfunction or cardiovascular diseases
- Having adult degenerative and secondary scoliosis
Trial locations and contacts
1 site in 1 country.
China1 site
Power-sling suspension device (SPS-F11, Nanjing Sbird Biotechnology Co., Ltd.)
Neijiang, Sichuan, 642450
About this study
Official title: Therapeutic Efficacy of Combined Sling Exercise Therapy and Conventional Exercise Therapy in Adult Idiopathic Scoliosis：A Randomized Controlled Trial
This study aims to compare the effects of suspension exercise therapy combined with conventional exercise therapy and conventional exercise therapy alone on pain, Cobb angle, functional impairment, and quality of life in adult patients with idiopathic scoliosis.
- Conditions
- Idiopathic Scoliosis, Adult
- Being tested
- Conventional exercise therapy, Suspension training and conventional exercise therapy
- Keywords
- Sling exercise training, Exercise therapy, Adult, Idiopathic scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional exercise therapyOther
Conventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes .
Suspension training and conventional exercise therapyOther
Suspension training alternates with conventional exercise therapy. It is conducted every other day, 45 minutes each time, 2-3 times a week for four consecutive weeks. Elastic ropes for suspension training are chosen based on patients' body mass: single - strand for those with body mass ≤ 30 kg and double - strand for those with body mass > 30 kg. Suspension slings are placed on the head, lower back, and pelvis, and non-elastic rope slings on the ankles. Lower the lifting bed so that the vertical distance from the ankles to the bed surface is about 25-30 cm.
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercise therapy group | Active comparator | Conventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes . Receives: Other: Conventional exercise therapy |
| Combined Intervention group | Experimental | Suspension training and conventional exercise therapy Receives: Other: Suspension training and conventional exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Measured: The measurements and evaluations were conducted on the first day of treatment and after the completion of the 30 - day treatment respectively.
Secondary outcomes (3)
Oswestry Disability Index
The Oswestry Disability Index (ODI) scale consists of 10 dimensions, such as walking, sitting, standing, and self-care ability. Each dimension is scored on a scale from 0 to 5 points, yielding a maximum total score of 50 points and a Minimum total score of 0 points. A higher score on the ODI indicates a more severe degree of functional impairment. The results of the ODI can be classified into four grades: a score range of 0%-20% suggests mild impairment; 21%-40% indicates moderate impairment; 41%-60% represents severe impairment; and 61%-100% reflects extremely severe functional impairment.
Measured: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.
Pain score (Visual Analogue Scale, VAS)
The Visual Analogue Scale（VAS） is a 0-10 scale, with 0 signifying no pain and 10 representing the most excruciating pain one can conceive. When administering the VAS, ensure that the graduated side of the scale is not visible to the patient. Then, ask the patient to mark the point on the ruler that reflects their current pain level. After that, the physician will assign a score according to the marked position. Based on the obtained score, pain can be classified as follows: a score of ≤3 indicates mild pain, 4-6 corresponds to moderate pain, and a score of ≥ 7 represents severe pain.
Measured: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.
Quality of life assessment (Scoliosis Research Society - 22 questionnaire, SRS - 22)
The Scoliosis Research Society-22 (SRS-22) questionnaire was employed to assess the QOL of patients. It evaluates quality of life across five dimensions: functional activities, pain, self -image, psychological state, and treatment satisfaction. Each item is scored from 1 to 5, and the total score, with a maximum of 110 and minimum of 0 , reflects a better QOL as it increases.
Measured: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start25 Apr 2025
- Primary completion25 May 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanlin Zou, Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109037
- Sponsor's protocol ID
- 2025001
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the patients' personal privacy from infringement and to make this part of data available for subsequent research.
Publications
Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.
PubMed 35859288Zhou Z, Liu F, Li R, Chen X. The effects of exercise therapy on adolescent idiopathic scoliosis: An overview of systematic reviews and meta-analyses. Complement Ther Med. 2021 May;58:102697. doi: 10.1016/j.ctim.2021.102697. Epub 2021 Feb 23.
PubMed 33636298
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Combined Sling Exercise Therapy and Conventional Exercise Therapy in Adult Idiopathic Scoliosis：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07109037
- Acronym / sponsor ID
- 2025001
- Conditions
- Idiopathic Scoliosis, Adult
- Keywords
- Sling exercise training, Exercise therapy, Adult, Idiopathic scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Southwest Medical UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 7 Aug 2025 (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.
This study aims to compare the effects of suspension exercise therapy combined with conventional exercise therapy and conventional exercise therapy alone on pain, Cobb angle, functional impairment, and quality of life in adult patients with idiopathic scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise therapy group | Active comparator | Other: Conventional exercise therapyConventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes . |
| Combined Intervention group | Experimental | Other: Suspension training and conventional exercise therapySuspension training and conventional exercise therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In the anteroposterior and lateral X-ray films of the spine in the standing position, the Cobb angle is ≥10° and <40°
- The age ranges from 18 to 75 years old
- No previous history of surgery
- Not wearing a corrective brace
Key exclusion criteria (4 listed)
- Having mental illnesses
- Having severe cognitive and communication disorders
- Having severe cardiopulmonary dysfunction or cardiovascular diseases
- Having adult degenerative and secondary scoliosis
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 |
|---|---|---|
| Conventional exercise therapyConventional exercise therapy includes four exercises: the "little swallow flying" exercise, the hip bridge exercise, back muscle stretching, and relaxation. It is performed once a day, 45 minutes . | Other | Conventional exercise therapy group |
| Suspension training and conventional exercise therapySuspension training alternates with conventional exercise therapy. It is conducted every other day, 45 minutes each time, 2-3 times a week for four consecutive weeks. Elastic ropes for suspension training are chosen based on patients' body mass: single - strand for those with body mass ≤ 30 kg and double - strand for those with body mass > 30 kg. Suspension slings are placed on the head, lower back, and pelvis, and non-elastic rope slings on the ankles. Lower the lifting bed so that the vertical distance from the ankles to the bed surface is about 25-30 cm. | Other | Combined Intervention group |
Primary outcome
Cobb angle
Time frame: The measurements and evaluations were conducted on the first day of treatment and after the completion of the 30 - day treatment respectively.
3 secondary outcomes
Oswestry Disability Index
Time frame: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.
Pain score (Visual Analogue Scale, VAS)
Time frame: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.
Quality of life assessment (Scoliosis Research Society - 22 questionnaire, SRS - 22)
Time frame: The evaluation was conducted on the first day of treatment and after the completion of the 30-day treatment respectively.
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 7 Aug 2025.
- Background: PubMed 35859288Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.
- Background: PubMed 33636298Zhou Z, Liu F, Li R, Chen X. The effects of exercise therapy on adolescent idiopathic scoliosis: An overview of systematic reviews and meta-analyses. Complement Ther Med. 2021 May;58:102697. doi: 10.1016/j.ctim.2021.102697. Epub 2021 Feb 23.
- Individual participant dataSharing planned: No. In order to protect the patients' personal privacy from infringement and to make this part of data available for subsequent research.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional exercise therapy and Suspension training and conventional exercise therapy in people with Idiopathic Scoliosis and Adult, run by Southwest Medical University 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 4 inclusion and 4 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 7 Aug 2025. 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?
Cobb angle (time frame: The measurements and evaluations were conducted on the first day of treatment and after the completion of the 30 - day treatment respectively.). 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 NCT07109037, which also lists 2 linked publications.
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 7 Aug 2025.