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
1 other identifier
observational
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedApril 21, 2022
April 1, 2022
3 years
April 3, 2017
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Muscle Elasticity
Change in muscle elasticity (in kilopascal )
From immediate pre-injection to 1 month post-injection.
Muscle Elasticity
Change in muscle elasticity (in m/s)
From immediate pre-injection to 1 month post-injection.
Secondary Outcomes (2)
Functional measures
immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Functional measures
immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Interventions
Botox injection in upper extremity for spasticity in pediatric CP patients
Eligibility Criteria
Patients with unilateral spastic CP 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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 13, 2017
Study Start
December 14, 2017
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share