Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis
A Prospective Clinical Study on the Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis
1 other identifier
interventional
172
1 country
1
Brief Summary
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 corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focuses on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional self-correction, balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally corrective exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally corrective exercise intervention on the change of Cobb angle, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life, compared to conventional exercise therapy for patients with mild and moderate AIS. Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be divided into two groups(experimental group or control group) according to their wishes. Subjects in experimental group will perform three-dimensionally corrective exercise for scoliosis (moderate patients combined with a brace) and those in the control group will receive conventional exercise therapy (moderate patients combined with a brace). Blinded assessments at baseline and immediately post 12-month intervention will include radiographic measurement, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 12, 2021
September 1, 2021
1.2 years
August 28, 2020
October 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 12 months
Secondary Outcomes (6)
Angle of trunk rotation
up to 12 months
Sagittal index
up to 12 months
Forced vital capacity
up to 12 months
Forced expiratory volume in first second
up to 12 months
Peak oxygen uptake
up to 12 months
- +1 more secondary outcomes
Study Arms (2)
Three-dimensionally corrective exercise for scoliosis
EXPERIMENTALExperimental group will perform three-dimensionally corrective 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 40-min period per day under the supervision of the parents at home.For moderate patients, additional brace treatment for more than 22 hours a day.The treatment regimens lasted for 12 months.
Conventional exercise
ACTIVE COMPARATORControl subjects will perform conventional exercise for a 60-min period for 1-2 times a week under the guidance of physical therapist in an outpatient clinic, and a 40-min period per day under the supervision of the parents at home. For moderate patients, additional brace treatment for more than 22 hours a day.The treatment regimens lasted for 12 months.
Interventions
Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focus on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional auto-correction(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.), balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient.
Conventional exercise consists a series of spine exercises focusing on core strength training.
Eligibility Criteria
You may qualify if:
- Age between 8-16;
- Definitely diagnosed as IS;
- Patients with Cobb angle greater than or equal to 10° and less than 45°.
You may not qualify if:
- Scoliosis caused by congenital, postural, neuromuscular or other diseases (such as neurofibromatosis, Marfan syndrome, bone dysplasia, metabolic or endocrine diseases, etc.);
- Patients suffering from mental illness or rheumatic disease;
- Patients with insufficient understanding ability to understand and complete the treatment plan;
- Patients with exercise contraindications who cannot tolerate exercise therapy;
- Patients with poor treatment compliance or refusal to treat;
- Patients with a history of rehabilitation or surgery before the first visit;
- Patients with apical vertebrae at T7 and above, or patients with mature bones.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Related Publications (1)
Zhou X, Li X, Wu Q, Liang J, Guo H, Jin M, Zhu X, Du Q. Three-dimensional corrective exercise therapy for idiopathic scoliosis: study protocol for a prospective non-randomized trial. BMC Musculoskelet Disord. 2022 Feb 5;23(1):118. doi: 10.1186/s12891-022-05057-7.
PMID: 35123460DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Qing Du, Ph.D
Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 7, 2020
Study Start
October 30, 2020
Primary Completion
December 31, 2021
Study Completion
September 30, 2022
Last Updated
October 12, 2021
Record last verified: 2021-09