Cerebral PalsyPhase 3NCT03302871
Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A
A Phase 3 study testing Botulinum toxin type A, transcranial direct current stimulation and hybrid training model of CIMT and BIT in people with Cerebral Palsy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these… Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum toxin type A, transcranial direct current stimulation and hybrid training model of CIMT and BIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2016to 30 Jan 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of unilateral cerebral palsy
- able to activate wrist and finger extensors
- being scheduled for BoNT-A treatment for upper limb
Who cannot join
- significant loss of wrist and or fingers
- history of orthopedic surgery to plegic upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A
Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.
In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.
Read the detailed description
Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum toxin type A, transcranial direct current stimulation, hybrid training model of CIMT and BIT, usual care
- Keywords
- cerebral palsy, botulinum toxin A, constraint induced movement therapy, transcranial direct current stimulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox, Dysport
transcranial direct current stimulationDevice
Also called noninvasiv brain stimulation
hybrid training model of CIMT and BITOther
usual careOther
Also called physical therapy
| Study group | Role | What they receive |
|---|---|---|
| İntensive Therapy Group | Experimental | Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT Receives: Drug: Botulinum toxin type A; Device: transcranial direct current stimulation; Other: hybrid training model of CIMT and BIT |
| Control Group | Active comparator | Children who received Botulinum toxin type A to plegic upper limb would continue their usual care Receives: Drug: Botulinum toxin type A; Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assesment
Bilateral Hand Function Evaluation Instrument
Measured: 6 weeks
Secondary outcomes (1)
Jebsen Taylor Hand Function Test
Unilateral Hand Function Evaluation Instrument
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start18 Jan 2016
- Primary completion30 Jan 2020
- Study completion30 Jan 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigar Dursun, Kocaeli University
- Investigators
- Nigar Dursun, MD, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302871
- Sponsor's protocol ID
- KOUKAEK 2016/20
- Status last verified
- Apr 2020
- First submitted
- 2 Oct 2017
- Last updated
- 24 Apr 2020
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A
- ClinicalTrials.gov ID
- NCT03302871
- Acronym / sponsor ID
- KOUKAEK 2016/20
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, botulinum toxin A, constraint induced movement therapy, transcranial direct current stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 5 Oct 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.
Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.
In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.
Detailed description
Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntensive Therapy Group | Experimental | Drug: Botulinum toxin type A, Device: transcranial direct current stimulation, Other: hybrid training model of CIMT and BITChildren who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT |
| Control Group | Active comparator | Drug: Botulinum toxin type A, Other: usual careChildren who received Botulinum toxin type A to plegic upper limb would continue their usual care |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosis of unilateral cerebral palsy
- able to activate wrist and finger extensors
- being scheduled for BoNT-A treatment for upper limb
Key exclusion criteria (2 listed)
- significant loss of wrist and or fingers
- history of orthopedic surgery to plegic 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 AAlso: Botox, Dysport | Drug | Control Group, İntensive Therapy Group |
| transcranial direct current stimulationAlso: noninvasiv brain stimulation | Device | İntensive Therapy Group |
| hybrid training model of CIMT and BIT | Other | İntensive Therapy Group |
| usual careAlso: physical therapy | Other | Control Group |
Primary outcome
Assisting Hand Assesment
Time frame: 6 weeks
Bilateral Hand Function Evaluation Instrument
1 secondary outcome
Jebsen Taylor Hand Function Test
Time frame: 6 weeks
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 24 Apr 2020.
- 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.
Nigar Dursun, MD 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, transcranial direct current stimulation and hybrid training model of CIMT and BIT 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 3 inclusion and 2 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 24 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?
Assisting Hand Assesment (time frame: 6 weeks). 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 24 Apr 2020.