Skip to main content
Clinical Trials/NCT03427970
NCT03427970
Unknown
Not Applicable

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country42 target enrollmentJune 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis,Idiopathic,Adolescent
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
42
Locations
1
Primary Endpoint
Change of Cobb angle
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2018
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qing Du

Ph.D

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Sagittal index(up to 6 months)
  • SRS-22 dimensions scores(up to 6 months)
  • Angle of trunk rotation(up to 6 months)

Study Sites (1)

Loading locations...

Similar Trials