Muscle Elastography in Spastic Cerebral Palsy

NCT ID: NCT03112434

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-14

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Unilateral Spastic Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Botulinum toxin type A

Botox injection in upper extremity for spasticity in pediatric CP patients

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiological Society of North America

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2016-628

Identifier Type: -

Identifier Source: org_study_id

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