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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03112434

Enrollment

Registered

2017-04-13

Start date

2017-12-14

Completion date

2020-12-30

Last updated

2022-04-21

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

Conditions

Unilateral Spastic Cerebral Palsy

Brief 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.

Interventions

DRUGBotulinum toxin type A

Botox injection in upper extremity for spasticity in pediatric CP patients

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Muscle Elasticity	From immediate pre-injection to 1 month post-injection.	Change in muscle elasticity (in kilopascal )

Secondary

Measure	Time frame	Description
Functional measures	immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.	Functional measures (MAS)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026