Cerebral Palsy, SpasticNCT03704155
Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy
A study testing Botulinum toxin type A and Physical Therapy in people with Cerebral Palsy, Spastic and Physical Therapy, run by University of Nove de Julho.
Trial summary
Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Physical Therapy, Botulinum Toxin
- What is being tested?
- Botulinum toxin type A and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of spastic Cerebral Palsy
- Clinical diagnosis of Dynamic equine feet
Who cannot join
- Use of phenol in the last 12 months
- Neurological blocks in the last 6 months
- Clinical diagnosis of structured orthopedic deformities with surgical indications
About this study
Official title: Effect of Botulinum Toxin Type A Associated With Physical Therapy on the Functional Capacity of Children With Spastic Cerebral Palsy: A Randomized Controlled Clinical Trial
Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.
- Conditions
- Cerebral Palsy, Spastic, Physical Therapy, Botulinum Toxin
- Being tested
- Botulinum toxin type A, Physical Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin type A The intervention with BoNT-A (Dysport®, Ipsen Biopharmaceutical, USA) was performed in the gastrocnemius and soleus muscles, bilaterally for diplegic children and unilaterally for hemiplegic children.
Physical TherapyOther
Physiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do.
The intervention protocol consisted of:
- Passive stretching of lower limbs,
- Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors;
- Strengthening of the antagonist muscles with the application of BoNT-A;
- Static and dynamic balance training;
- Up and down stairs;
- Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (EG) | Experimental | The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training). Receives: Drug: Botulinum toxin type A; Other: Physical Therapy |
| Control group (CG) | Active comparator | GC was treated with physiotherapy (stretching, balancing training, functional walking training). Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of muscle hypertonia
The classification of hypertonia was performed by Modified Ashworth Scale
Measured: 3 months
Functional balance
Functional balance was assessed using the Berg Balance Scale (BBS).
Measured: 3 months
Secondary outcomes (2)
Functional mobility
Functional mobility was performed by The Timed Up and Go test (TUG test).
Measured: 3 months
Functional performance
Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study startJan 2017
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez
- Responsible party
- Principal investigator, Fabiano Politti, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704155
- Sponsor's protocol ID
- BTA
- Status last verified
- Oct 2018
- First submitted
- 4 Jul 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Botulinum Toxin Type A Associated With Physical Therapy on the Functional Capacity of Children With Spastic Cerebral Palsy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03704155
- Acronym / sponsor ID
- BTA
- Conditions
- Cerebral Palsy, Spastic, Physical Therapy, Botulinum Toxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 12 Oct 2018 (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.
Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group (EG) | Experimental | Drug: Botulinum toxin type A, Other: Physical TherapyThe EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training). |
| Control group (CG) | Active comparator | Other: Physical TherapyGC was treated with physiotherapy (stretching, balancing training, functional walking training). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of spastic Cerebral Palsy
- Clinical diagnosis of Dynamic equine feet
Key exclusion criteria (3 listed)
- Use of phenol in the last 12 months
- Neurological blocks in the last 6 months
- Clinical diagnosis of structured orthopedic deformities with surgical indications
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 ABotulinum Toxin type A The intervention with BoNT-A (Dysport®, Ipsen Biopharmaceutical, USA) was performed in the gastrocnemius and soleus muscles, bilaterally for diplegic children and unilaterally for hemiplegic children. | Drug | Experimental group (EG) |
| Physical TherapyPhysiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do. The intervention protocol consisted of: * Passive stretching of lower limbs, * Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors; * Strengthening of the antagonist muscles with the application of BoNT-A; * Static and dynamic balance training; * Up and down stairs; * Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion. | Other | Control group (CG), Experimental group (EG) |
Primary outcome
Severity of muscle hypertonia
Time frame: 3 months
The classification of hypertonia was performed by Modified Ashworth Scale
Functional balance
Time frame: 3 months
Functional balance was assessed using the Berg Balance Scale (BBS).
2 secondary outcomes
Functional mobility
Time frame: 3 months
Functional performance
Time frame: 3 months
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 12 Oct 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A and Physical Therapy in people with Cerebral Palsy, Spastic and Physical Therapy, run by University of Nove de Julho.
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 3 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 12 Oct 2018. 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.
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?
Severity of muscle hypertonia (time frame: 3 months). 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 12 Oct 2018.