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Explore the effect of local injection of BTX-A combined with mCIMT on upper limb muscle synergism in children with spastic hemiplegia and brain mechanism study

Explore the effect of local injection of BTX-A combined with mCIMT on upper limb muscle synergism in children with spastic hemiplegia and brain mechanism study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093364
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-12-03
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Spastic cerebral palsy hemiplegia: cerebral palsy (CP), short for cerebral palsy, is a group of syndromes of persistent disorders of motor and postural development caused by non-progressive injury to the brain of the developing fetus or infant.Most of the CPs are accompanied by upper limb dysfunction, with a prevalence of upper limb dysfunction ranging from 57% to 83%, and is most commonly seen in

Interventions

B Group:botulinum neurotoxin A (BTX-A)
C Group:botulinum neurotoxin A (BTX-A)
Group of normally developing children:None, only used as a routine control
A Group:Modified Compulsory Exercise Therapy (m CIMT)

Sponsors

Shanghai Yangzhi rehabilitation hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.Meets the diagnostic criteria for spastic hemiplegia in the 2022 China Cerebral Palsy Rehabilitation Guidelines. 2.Age 2-6 years old; 3.Hand function grading system (MACS) for children with cerebral palsy is graded I~IV; 4.Parents sign an informed consent form and are able to cooperate with the treatment;

Exclusion criteria

Exclusion criteria: 1.the child has a combination of neuropsychiatric or physical illnesses other than cerebral palsy. 2. Those with recent uncontrolled seizures; 3. Use of implanted electronic devices (e.g., cochlear implants, pacemakers, etc.) with metallic implanted devices in the cranium or therapeutic area; 4. Combined with other neurological or medical diseases that cause unstable vital signs; 5. Treatment area pain sensitization, local skin injury or bleeding tendency; 6. Botulinum toxin injections or other related treatments for the upper limb on the hemiplegic side in the last 3 months;

Design outcomes

Primary

MeasureTime frame
Surface EMG muscle synergy values;

Secondary

MeasureTime frame
Modification of the Ashworth Myotonia Assessment Scale (MAS);upper extremity functional test;Peabody Fine Motor Development Scale;Children's Functional Independence Rating Scale (Wee FIM);Near Infrared Imaging Detection (fNIRS);

Countries

China

Contacts

Public Contactcaoqianru

Shanghai Yangzhi rehabilitation hospital

2511007192@qq.com+86 13548630179

Outcome results

None listed

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