Unilateral Spastic Cerebral PalsyNCT03112434
Muscle Elastography in Spastic Cerebral Palsy
An observational study of Unilateral Spastic Cerebral Palsy, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Unilateral Spastic Cerebral Palsy
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With 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.
- Conditions
- Unilateral Spastic Cerebral Palsy
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ADrug
Botox injection in upper extremity for spasticity in pediatric CP patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Elasticity
Change in muscle elasticity (in kilopascal )
Measured: From immediate pre-injection to 1 month post-injection.
Muscle Elasticity
Change in muscle elasticity (in m/s)
Measured: From immediate pre-injection to 1 month post-injection.
Secondary outcomes (2)
Functional measures
Functional measures (MAS)
Measured: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Functional measures
Functional measures (PROM)
Measured: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start14 Dec 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112434
- Sponsor's protocol ID
- 2016-628
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03112434
- Acronym / sponsor ID
- 2016-628
- Conditions
- Unilateral Spastic Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type ABotox injection in upper extremity for spasticity in pediatric CP patients | Drug | – |
Primary outcome
Muscle Elasticity
Time frame: From immediate pre-injection to 1 month post-injection.
Change in muscle elasticity (in kilopascal )
Muscle Elasticity
Time frame: From immediate pre-injection to 1 month post-injection.
Change in muscle elasticity (in m/s)
2 secondary outcomes
Functional measures
Time frame: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Functional measures
Time frame: immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Spastic Cerebral Palsy, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Elasticity (time frame: From immediate pre-injection to 1 month post-injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.