Spastic Diplegic Cerebral PalsyPhase 3NCT00261131
Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy
A Phase 3 study testing Botulinum Toxin A in people with Spastic Diplegic Cerebral Palsy, run by Shriners Hospitals for Children.
Trial summary
The study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Botulinum Toxin A
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Dec 2007
- Phase
- Phase 3
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Spastic cerebral palsy;
- Bilateral lower extremity involvement;
- Spasticity present in the hamstrings;
- Flexed knee gait >15 degrees by observation (OGS);
- Age between 3 and 18 years old; (
- GMFCS Level I to Level IV; (
Show all 10Show fewer
- Able to walk a minimum of 4 complete steps without resting with and without braces/shoes a minimum of 3 times;
- Able to follow simple commands;
- Cooperative with physicians and therapist;
- Able to tolerate application of equipment to the skin.
Who cannot join
- Rhizotomy surgery within the last 1 year;
- Lower extremity surgical procedures (soft tissue or bony) within the past 1 year;
- Currently implanted and operating Intrathecal Baclofen Pump (oral baclofen OK);
- Lower extremity BTX-A injections within the past 6 months;
- Multilevel BTX-A injections;
- Gait trainer reliance;
- Serial casting 3 months prior to or during study protocol.
About this study
Official title: Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled Trial
The study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.
Read the detailed description
This study proposes to: (1) to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic (body structure and body function) changes not observed with normal saline injections, in children with spastic diplegic CP who walk with a flexed-knee gait pattern; (2) to assess whether physiologic changes translate into functional (activity and participation) improvements; (3) to evaluate family's perception of change in function, activity, participation, and quality of life.
This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy (CP) and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning, Disability, and Health (ICF). It is a multi-center, prospective, randomized, double-blind trial comparing results of injection of BTX- A and placebo saline in controls, into overactive hamstring muscles, using multiple outcomes measures. Temporal-spatial gait parameters, instrumented 3DGA kinematics, passive ROM, spasticity measurement with both Ashworth and Tardieu scales, muscle strength/control, Gross Motor Function Measurement (GMFM), Pediatric Outcomes Data Collection Instrument (PODCI), Gillette Functional Assessment Questionnaire (FAQ), 6-Minute Walk Test, and Goal Attainment Scale (GAS), assessing all ICF domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection. Power analysis demonstrates the need to randomize 250 children (125 with BTX-A, 125 with saline), allowing for attrition. Nine participating hospitals will contribute patients.
- Conditions
- Spastic Diplegic Cerebral Palsy
- Being tested
- Botulinum Toxin A
- Keywords
- cerebral palsy, spasticity, diplegia
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
3DGA Kinematics
Passive Range of Motion
Spasticity Measurement with AShworth and Tardieu Scales
Muscle Strength and Control
Secondary outcomes (5)
Gross Motor Function Measurement (GMFM)
Pediatric Outcomes Data Collection Instrument (PODCI)
Gillette Functional Assessment Questionnaire (GFAQ)
6-Minute Walk Test
Goal Attainment Scale (GAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startMar 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegic 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Investigators
- Philip E. Gates, MD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261131
- Sponsor's protocol ID
- 9199
- Status last verified
- Feb 2009
- First submitted
- 30 Nov 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00261131
- Acronym / sponsor ID
- 9199
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- cerebral palsy, spasticity, diplegia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- University of Virginia, Washington University School of Medicine
- Study start
- Mar 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Dec 2005 (estimated)
- 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.
The study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.
Detailed description
This study proposes to: (1) to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic (body structure and body function) changes not observed with normal saline injections, in children with spastic diplegic CP who walk with a flexed-knee gait pattern; (2) to assess whether physiologic changes translate into functional (activity and participation) improvements; (3) to evaluate family's perception of change in function, activity, participation, and quality of life.
This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy (CP) and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning, Disability, and Health (ICF). It is a multi-center, prospective, randomized, double-blind trial comparing results of injection of BTX- A and placebo saline in controls, into overactive hamstring muscles, using multiple outcomes measures. Temporal-spatial gait parameters, instrumented 3DGA kinematics, passive ROM, spasticity measurement with both Ashworth and Tardieu scales, muscle strength/control, Gross Motor Function Measurement (GMFM), Pediatric Outcomes Data Collection Instrument (PODCI), Gillette Functional Assessment Questionnaire (FAQ), 6-Minute Walk Test, and Goal Attainment Scale (GAS), assessing all ICF domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection. Power analysis demonstrates the need to randomize 250 children (125 with BTX-A, 125 with saline), allowing for attrition. Nine participating hospitals will contribute patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Spastic cerebral palsy;
- Bilateral lower extremity involvement;
- Spasticity present in the hamstrings;
- Flexed knee gait >15 degrees by observation (OGS);
- Age between 3 and 18 years old; (
Key exclusion criteria (7 listed)
- Rhizotomy surgery within the last 1 year;
- Lower extremity surgical procedures (soft tissue or bony) within the past 1 year;
- Currently implanted and operating Intrathecal Baclofen Pump (oral baclofen OK);
- Lower extremity BTX-A injections within the past 6 months;
- Multilevel BTX-A injections;
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 A | Drug | – |
Primary outcome
3DGA Kinematics
Passive Range of Motion
Spasticity Measurement with AShworth and Tardieu Scales
Muscle Strength and Control
5 secondary outcomes
Gross Motor Function Measurement (GMFM)
Pediatric Outcomes Data Collection Instrument (PODCI)
Gillette Functional Assessment Questionnaire (GFAQ)
6-Minute Walk Test
Goal Attainment Scale (GAS)
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 5 Feb 2009.
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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.
Philip E. Gates, MD principal investigator
Shriners Hospitals for Children
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin A in people with Spastic Diplegic Cerebral Palsy, run by Shriners Hospitals for Children.
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 10 inclusion and 7 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 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
3DGA Kinematics. The study lists 4 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 5 Feb 2009.