NCT06643104

Brief Summary

This study focuses on adolescents with idiopathic scoliosis, employing 3D imaging technology with depth cameras to measure back height difference (BHD) and angle of trunk rotation (ATR) before and after conventional treatments such as massage, exercise therapy, and bracing. Statistical analyses are conducted to verify the correlation between BHD and ATR and to assess the sensitivity of BHD in evaluating short-term treatment effectiveness.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

October 13, 2024

Last Update Submit

October 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Back height difference

    Using depth cameras to acquire back data, point cloud processing algorithms analyze the information. The height difference between the highest point on the convex side and the corresponding point on the concave side is measured, with three repetitions taken to calculate the average value.

    Day 1 of Admission and Day 5 of Admission

Secondary Outcomes (1)

  • Angle of trunk rotation

    Day 1 of Admission and Day 5 of Admission

Study Arms (1)

BHD

Procedure: Tuina

Interventions

TuinaPROCEDURE

X-ray mapping guides three days of tailored exercises, including 3D therapy, breathing techniques, and spinal manipulation.

Also known as: Tuina, sports gymnastics
BHD

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study focuses on adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis, defined by a Cobb angle of ≥10°.

You may qualify if:

  • (1) Adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (AIS) with a Cobb angle ≥10°; (2) No history of spinal surgery or other corrective treatments; (3) Able to undergo short-term inpatient treatment (5 days) and comply with study procedures.

You may not qualify if:

  • (1) Patients with congenital, neuromuscular, or other secondary scoliosis; (2) Presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) Patients unable to complete standardized assessment procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2024

First Posted

October 16, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations