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

NCT03427970 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-10-22

No results posted yet for this study

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.

Conditions

  • Scoliosis,Idiopathic,Adolescent

Interventions

BEHAVIORAL

observation

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

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.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Qing Du, Ph.D · Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427970 on ClinicalTrials.gov