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Mathematical modeling-based disease progression mechanism and biomechanical intervention of the "spine-lower extremity-brain network" in idiopathic scoliosis

Mathematical modeling-based disease progression mechanism and biomechanical intervention of the "spine-lower extremity-brain network" in idiopathic scoliosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087144
Enrollment
Unknown
Registered
2024-07-22
Start date
2024-07-24
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Idiopathic scoliosis

Interventions

Mild IS experimental group:Biomechanical orthotic insole intervention
Moderate IS experimental group:Biomechanical orthotic insole intervention
Severe IS experimental group:Biomechanical orthotic insole intervention
Mild IS control group:None
Moderate IS control group :None
Severe IS control group:None

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. the age of the patients included in this study was between 10 and 50 years old, and there was no gender limitation; 2. patients with clinical and auxiliary examination diagnosis of IS; 3. body mass index was within the range of ±10% of the standard; 4. all the subjects were right-handed; 5. there were no psychiatric or neurological disorders, and there were no serious cardiac, hepatic or renal organic diseases; 6. there were no contraindications to the examination of MRI, and there were no abnormal foci in the brain; 7. the patients signed the "informed consent form" and agreed to participate in the program.

Exclusion criteria

Exclusion criteria: 1. other important organ injuries and limb disfigurement caused by trauma; 2. important organ dysfunction such as heart, lungs, liver and kidney; 3. severe muscle spasms and pain in the lower limbs; 4. history of epileptic seizures; 5. deformities of the spine, lower limb joints, localized infections, etc.; 6. significant cognitive or speech disorders, etc., resulting in inability to cooperate with the examination and orthopedic training; 7. inability to adhere to the completion of the treatment; 8. inability to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
SRS-22;Ultrasonographic static structural testing of the paraspinal musculoskeletal muscles;Paravertebral muscle surface electromyography dynamic function test;Static testing of lower extremity biomechanical indices;Dynamic testing of biomechanical indicators of the lower limb;

Secondary

MeasureTime frame
Hamilton Depression Scale, HAMD;Hamilton Anxiety Rating Scale, HAMA;SF-36;Brain network static structure test;Brain Network Dynamic Structure Test;

Countries

China

Contacts

Public ContactXu Yi

Department of Rehabilitation Medicine, The Seventh Affiliated Hospital of Sun Yat-sen University

xuyi@sysush.com+86 177 0208 4992

Outcome results

None listed

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