Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis

NCT ID: NCT03427970

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2021-12-31

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.

Conditions

Scoliosis,Idiopathic,Adolescent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Control subjects will receive observation for 6 months.

Group Type: ACTIVE_COMPARATOR

observation

Intervention Type: BEHAVIORAL

Control group will receive the standard of care according to the Scoliosis Research Society criteria: observation for patients with curves between 10°- 25°.

experimental group

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.

Group Type: EXPERIMENTAL

three-dimensionally integrated exercise for scoliosis

Intervention Type: BEHAVIORAL

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.

Interventions

observation

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

three-dimensionally integrated exercise for scoliosis

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qing Du

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qing Du, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine

Locations

Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qing Du, Ph.D

Role: CONTACT

duqing810@126.com

+86 021-25078999 ext. 8600

Xuan Zhou, M.M

Role: CONTACT

zhouxuanxh@163.com

+86 021-25078999 ext. 8609

Facility Contacts

Guangyu Chen, MD

Role: primary

xinhuacru@163.com

+86 021-25078999 ext. 7485

References

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.

Reference Type: DERIVED

PMID: 30201050 (View on PubMed)

Other Identifiers

XH-18-004

Identifier Type: -

Identifier Source: org_study_id