Trial on Two Treatments for Adolescent Idiopathic Scoliosis

NCT05259956 | Completed

• 1 other identifier: HP2022-50-507005
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. The purpose of this study is to compare the effectiveness of pelvic adjustments accompanied with Schroth-based exercises, with the latter alone in adolescent idiopathic scoliosis, to assess the impact of pelvic asymmetry on the spinal three-dimensional parametric features in scoliosis.

Conditions

Scoliosis; Adolescence

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Ratio of Iliac Widths at 24th week

  Rotation in the transverse plane of pelvic seen on a spinal standing full-length posteroanterior radiograph.

  baseline and at 24th week

Secondary Outcomes (6)

• Change in Cobb Angle

  baseline and at 24th week

• Change in Apical Vertebral Translation in Main Curves

  baseline and at 24th week

• Change in Coronal Pelvic Tilt

  baseline and at 24th week

• Change in Apical Vertebral Rotation in Main curves

  baseline and at 24th week

• Change in Angle of Trunk Rotation

  baseline and at 24th week

Study Arms (2)

"3 plus 1" multidimensional exercise therapy

EXPERIMENTAL

The intervention consists of a Schroth-based exercise session and a manipulative therapy of pelvic asymmetry.

Behavioral: "3 plus 1" multidimensional exercise therapy

Schroth based scoliosis specific exercise

ACTIVE COMPARATOR

The intervention consists of the Schroth-based exercise session.

Behavioral: Schroth based scoliosis specific exercise

Interventions

Schroth based scoliosis specific exercise BEHAVIORAL

The intervention is set to be delivered in a one-hour Schroth-based exercise session, with the frequency of twice a week for five weeks. The exercise consists of active auto-correction in 3D, stabilizing the corrected posture, and training in ADL.

Schroth based scoliosis specific exercise

"3 plus 1" multidimensional exercise therapy BEHAVIORAL

The intervention is set to be delivered in a 90-minute exercise session, with a frequency of twice a week for five weeks. The exercise consists of a one-hour Schroth-based exercise session and an additional 30-minute manipulative therapy of pelvic asymmetry.

"3 plus 1" multidimensional exercise therapy

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5).

You may not qualify if:

• Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.

Sponsors & Collaborators

• Peking University Aerospace Center Hospital: lead

Study Sites (1)

Zhang yafei

Beijing, China

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Zhang Meng

  Aerospace Centre Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 2, 2022
• Study Start: February 18, 2022
• Primary Completion: April 7, 2023
• Study Completion: April 7, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

CN (1)