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Completed

NCT Number: NCT03112434

Muscle Elastography in Spastic Cerebral Palsy

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.

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Key information

Conditions

Unilateral Spastic Cerebral Palsy

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Botox injection in upper extremity for spasticity in pediatric CP patients

Primary outcomes

  1. Muscle Elasticity

    Time frame: From immediate pre-injection to 1 month post-injection.

    Change in muscle elasticity (in kilopascal )

  2. Muscle Elasticity

    Time frame: From immediate pre-injection to 1 month post-injection.

    Change in muscle elasticity (in m/s)

Secondary outcomes

  1. Functional measures

    Time frame: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.

    Functional measures (MAS)

  2. Functional measures

    Time frame: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.

    Functional measures (PROM)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Radiological Society of North America

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2017
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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