NCT03112434

Muscle Elastography in Spastic Cerebral Palsy

Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With Spastic Cerebral Palsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.

Conditions

• Unilateral Spastic Cerebral Palsy

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Botox injection in upper extremity for spasticity in pediatric CP patients

Timeline

• Start date: 2017-12-14
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2017-04-13
• Last updated: 2022-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study