Muscle Elastography in Spastic Cerebral Palsy

Unilateral Spastic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112434
• Other study ID #: 2016-628
• Status: Completed
• Start date: December 14, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent.

• Consent may be obtained from a parent or legal guardian, as applicable.

Exclusion Criteria:

• Prior surgical procedure in the affected upper extremity

• Unrelated orthopedic injury to the affected upper extremity

• Current oral or intrathecal antispasticity therapy

• Prior Botulinum toxin type A injection in preceding 6 months

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Unilateral Spastic Cerebral Palsy

Intervention

Drug:
• Botulinum toxin type A
Botox injection in upper extremity for spasticity in pediatric CP patients

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Elasticity	Change in muscle elasticity (in kilopascal )	From immediate pre-injection to 1 month post-injection.
Primary	Muscle Elasticity	Change in muscle elasticity (in m/s)	From immediate pre-injection to 1 month post-injection.
Secondary	Functional measures	Functional measures (MAS)	immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Secondary	Functional measures	Functional measures (PROM)	immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.