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Study on the Safety and Efficacy of Extracorporeal Shock Wave Combined with Botulinum Toxin in the Treatment of Children with Spastic Cerebral Palsy

Study on the Safety and Efficacy of Extracorporeal Shock Wave Combined with Botulinum Toxin in the Treatment of Children with Spastic Cerebral Palsy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080899
Enrollment
Unknown
Registered
2024-02-18
Start date
2024-02-19
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

cerebral palsy

Interventions

Intervention:botulinum toxin, Extracorporeal shock wave therapy, Conventional rehabilitation therapy
Control :botulinum toxin, Conventional rehabilitation therapy

Sponsors

Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Children with spastic cerebral palsy aged 2-18; 2. Modified Ashworth Scale (MAS) for triceps surae muscle tone >1+ level; 3. Gross Motor Function Classification levels 1-3; 4. No other severe internal medical conditions; 5. Informed consent signed by a guardian.

Exclusion criteria

Exclusion criteria: 1.Received botulinum toxin or other muscle tone modulating treatments within the last 6 months prior to enrollment; 2. Undergone surgical treatment on the lower limbs; 3. Severe joint contractures in the lower limbs, with iliopsoas, hamstring, and adductor muscles having an MAS score greater than level 2; 4. Local infection and skin breakdown; 5. Sensory abnormalities; 6. Coagulation dysfunction; 7. Guardian refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
Duration of therapeutic effect;Modified Ashworth Scale;Modified Tardieu Scale;Physicians Rating Scale,PRS;

Secondary

MeasureTime frame
Gross motor function measure,GMFM-88;Time up and go,TUG;

Countries

China

Contacts

Public ContactXiaoyin Huang

Guangzhou Women and Children's Medical Center, Guangzhou Medical University

elvis0310@foxmail.com+86 135 8056 1456

Outcome results

None listed

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