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A clinical study on different doses of botulinum toxin A injection on the lower extremities spasm in children with cerebral palsy by ultrasound guidance

A clinical study on botulinum toxin A injection for spastic cerebral palsy by ultrasound guidance

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006318
Enrollment
Unknown
Registered
2015-04-30
Start date
2015-06-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

cerebral palsy

Interventions

The experimental group 9 to 18 months:3U/Kg botulinum toxin A injection and Rehabilitation training
The experimental group 9 to 18 months:5U/Kg botulinum toxin A injection and Rehabilitation training
The experimental group 18 to 36 months:3U/Kg botulinum toxin A injection and Rehabilitation training
The experimental group 18 to 36 months:5U/Kg botulinum toxin A injection and Rehabilitation training
The control group 9 to 18 months:Rehabilitation training
The control group 18 to 36 months:Rehabilitation training

Sponsors

The third affiliated hospital of Zhengzhou university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. meet to the diagnosis standard of spasm cerebral palsy; 2. the spasm of cerebral palsy children with tetraplegia, double paralysis, hemiplegia from 2015.05 to 2017.01 at Rehabilitation Center for Children with Cerebral Palsy in Henan Province, the Third Affiliated Hospital of Zhengzhou University; 3. In the lower extremities calf, hamstring and adduction muscle group for the target muscle; 4. the age between 9 and 36 months old.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution, severe liver and kidney function damage; 2. Neuromuscular joint lesions; The injection site andother areas of the body is infection; 3. Drugs which can increase nerve muscle joint disorder in 1week was applied; 4. Existing joint fixed, severe muscle contracture injection.

Design outcomes

Primary

MeasureTime frame
modified Tardieu scale;

Secondary

MeasureTime frame
Gross Motor Function Measure;Passive Rang Of Motion;pennation angle;fascicle lengths;thickness of muscle;

Countries

China

Contacts

Public ContactZhu Dengna

The Third Affiliated Hospital of Zhengzhou University

zhudengna@126.com+86 13838141626

Outcome results

None listed

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