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Multicenter, randomized, parallel-controlled, superiority clinical trial of a scoliosis-correcting robot

Multicenter, randomized, parallel-controlled, superiority clinical trial of a scoliosis-correcting robot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093851
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-08-12
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adolescent idiopathic scoliosis

Interventions

experimental group:Scoliosis-correcting robot assists subjects in performing physiotherapeutic scoliosis-specific exercise
control group: physiotherapeutic scoliosis-specific exercise

Sponsors

Huazhong University of Science and Technology/ Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Age 8-18 years and regardless of gender; (2) Diagnosis of idiopathic scoliosis; (3) Confirmation of the Cobb angle between 10° and 45° by radiographs of the full length of the spine; (4) Radiographs showed Risser's sign < grade 5; (5) Good compliance of the patient and parent; (6) Patients who had a full understanding of the study and voluntarily signed the informed consent before participating in the study, and who were able to complete the treatment procedures as expected.

Exclusion criteria

Exclusion criteria: (1) Chromosomal abnormalities, peripheral neuropathy, muscular disorders, post-polio sequelae, spinal cord cavernous disease, hemivertebra, butterfly spine; (2) Excluding scoliosis caused by external forces, such as herniated disc; (3) Suffer from spinal tumour, spinal tuberculosis and other spine-related diseases; (4) Those suffering from osteoporosis, local skin redness, breakage, bleeding or infection that cannot tolerate the mechanical effects; (5) Those who suffer from Nutcracker syndrome, low back pain, muscle injury, etc; (6) Those who suffer from severe cardiopulmonary diseases, hypertension and other underlying diseases; (7) Patients after spinal surgery; (8) Those with spinal fractures and dislocations that require strict immobilisation; (9) Patients with congenital spinal vertebral deformity; (10) Pregnant women; (11) Patients with mental illness; (12) Those who, in the opinion of the investigator, should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
angle of trunk rotation correction efficiency;

Secondary

MeasureTime frame
Cobb angle correction efficiency;Morphological analysis of the body;Immediate correction rate of instruments;SRS-22 questionnaire scores;

Countries

China

Contacts

Public ContactXiaolin Huang

Huazhong University of Science and Technology, Tongji Medical College,Tongji Hospital

m202276289@hust.edu.cn+86 83668317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026