Cerebral PalsyPhase 3NCT03472261
Integrated Management of Pronation Deformity in Cerebral Palsy
A Phase 3 study testing Botulinum toxin type A, Upper extremity orthoses and Home exercise program in people with Cerebral Palsy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. . Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum toxin type A, Upper extremity orthoses and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2018to 30 Mar 2020
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cerebral palsy
- MAS score of pronator muscles at least 2
- Gross Motor Functional Classification Scale level of I-IV
- Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles
Who cannot join
- Severe cognitive or behavioural problems
- Less than 40 degrees of available passive range of motion in pronation
- Severe dystonia in the affected upper limb
- Received orthopedic surgery to affected upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A
Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .
Read the detailed description
Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature.
In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum toxin type A, Upper extremity orthoses, Home exercise program
- Keywords
- cerebral palsy, botulinum toxin-A, pronator deformity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport
Upper extremity orthosesOther
Twister
Home exercise programOther
Specific exercises for pronation deformity
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients treated by Botulinum toxin A and twister and specific home exercise program Receives: Drug: Botulinum toxin type A; Other: Upper extremity orthoses; Other: Home exercise program |
| Conventional Therapy Group | Active comparator | Patients treated by Botulinum toxin A and specific home exercise program Receives: Drug: Botulinum toxin type A; Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline Modified Ashworth Scale (MAS)
Tone measurement
Measured: Week 12
Secondary outcomes (3)
Mean change from baseline passive range of supination
Range of motion measurement
Measured: Week 12
Mean change from baseline angle of catch (XV3) Tardieu scale
Spasticity measurement
Measured: Week 12
Mean change from baseline active range of supination
Active range of motion
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start26 Mar 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigar Dursun, Kocaeli University
- Investigators
- Melike Akarsu, MSc, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472261
- Sponsor's protocol ID
- KU GOKAEK 2018/8
- Status last verified
- Apr 2020
- First submitted
- 14 Mar 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A
- ClinicalTrials.gov ID
- NCT03472261
- Acronym / sponsor ID
- KU GOKAEK 2018/8
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, botulinum toxin-A, pronator deformity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 21 Mar 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.
Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .
Detailed description
Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature.
In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Botulinum toxin type A, Other: Upper extremity orthoses, Other: Home exercise programPatients treated by Botulinum toxin A and twister and specific home exercise program |
| Conventional Therapy Group | Active comparator | Drug: Botulinum toxin type A, Other: Home exercise programPatients treated by Botulinum toxin A and specific home exercise program |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of cerebral palsy
- MAS score of pronator muscles at least 2
- Gross Motor Functional Classification Scale level of I-IV
- Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles
Key exclusion criteria (4 listed)
- Severe cognitive or behavioural problems
- Less than 40 degrees of available passive range of motion in pronation
- Severe dystonia in the affected upper limb
- Received orthopedic surgery to affected upper limb
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 ADysport | Drug | Conventional Therapy Group, Experimental Group |
| Upper extremity orthosesTwister | Other | Experimental Group |
| Home exercise programSpecific exercises for pronation deformity | Other | Conventional Therapy Group, Experimental Group |
Primary outcome
Mean change from baseline Modified Ashworth Scale (MAS)
Time frame: Week 12
Tone measurement
3 secondary outcomes
Mean change from baseline passive range of supination
Time frame: Week 12
Mean change from baseline angle of catch (XV3) Tardieu scale
Time frame: Week 12
Mean change from baseline active range of supination
Time frame: Week 12
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 16 Apr 2020.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Melike Akarsu, MSc principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A, Upper extremity orthoses and Home exercise program in people with Cerebral Palsy, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 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 16 Apr 2020. 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 Turkey (Türkiye). 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.
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?
Mean change from baseline Modified Ashworth Scale (MAS) (time frame: Week 12). 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 16 Apr 2020.