Cerebral PalsyNCT04256187
Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy
An observational study of Cerebral Palsy and Botulinum Toxin, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to quantitatively record the opinions regarding the pros and cons of this treatment of the caregivers of children with cerebral palsy who had botulinum toxin applied in investigators' clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Palsy, Botulinum Toxin
- What is being tested?
- Qualitative interview
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Jan 2021
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Caregivers of children who treated with botulinum toxin.
Who may be able to join
- To be the caregiver of a patient under 18 years old with cerebral palsy
- No attempt has been made to reduce spasticity such as botulinum toxin injection in the last 3 months.
Who cannot join
- Not knowing Turkish
- Refusing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34890
About this study
Official title: Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy: A Qualitative Study Examining the Caregiver's Perspectives
The aim of this study is to quantitatively record the opinions regarding the pros and cons of this treatment of the caregivers of children with cerebral palsy who had botulinum toxin applied in investigators' clinic.
Read the detailed description
Spasticity is defined as an increase in physiological resistance of the muscles associated with a lack of supraspinal inhibition against passive strain. It is a common and prohibitive problem associated with an increase in tendon reflex and tension reflex associated with upper motor neuron dysfunction. One of the most common problems in patients with CP.
Methods used in the treatment of spasticity; medical therapy, physical therapy, intrathecal baclofen pump, botulinum toxin injection, and orthopedic correction operations. However, botulinum toxin type-A (BTX-A) injections, which are applied to the muscles especially for localized spasticity, have become an effective adjuvant option that increases the effectiveness of classical methods and diversifies the treatment options.
BTX-A, which is basically a chemodenervation method; It is a treatment method that blocks the transmission of signal in the neuromuscular junction by preventing the release of acetylcholine vesicles into the presynaptic space. In spastic muscles, relaxation can be achieved by correct injection. Botulinum toxin type A has been shown to be an effective and safe treatment for children to reduce spasticity.
In Turkish society, there is no study evaluating the caregivers' experiences and opinions about botox treatments of patients with the diagnosis of cerebral palsy and limited studies in the literature are from countries with different sociodemographic features such as the United States and the United Kingdom. Although these patients have been receiving this treatment in investigators' center for years, there is no study in the literature that evaluates the plus and minus aspects of caregivers' experiences in this regard.
- Conditions
- Cerebral Palsy, Botulinum Toxin
- Being tested
- Qualitative interview
- Keywords
- botulinum toxin, cerebral palsy, experiences, spasticity, caregivers
- 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.
Qualitative interviewOther
Qualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Caregivers of children who treated with botulinum toxin. Receives: Other: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of Botulinum toxin treatment
Qualitative interview performed at one occasion where the caregivers describes the experience about the their childrens' botulinum toxin treatment.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Nov 2019
- Primary completion30 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayca Evkaya, Res. Asst., Principal investigator, Physiotherapy and Rehabilitation Department, Maltepe UniversityOzge Kenis Coskun, Asts. Prof., Principal investigator, Physical Medicine and Rehabilitation Department, Marmara University, IstanbulPemra Cobek Unalan, Prof, Principal investigator, Family Medicine Department, Marmara University, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256187
- Sponsor's protocol ID
- 09.2020.114
- Status last verified
- Jan 2021
- First submitted
- 3 Feb 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barry MJ. Physical therapy interventions for patients with movement disorders due to cerebral palsy. J Child Neurol. 1996 Nov;11 Suppl 1:S51-60. doi: 10.1177/0883073896011001S08.
PubMed 8959462Corry IS, Cosgrove AP, Duffy CM, McNeill S, Taylor TC, Graham HK. Botulinum toxin A compared with stretching casts in the treatment of spastic equinus: a randomised prospective trial. J Pediatr Orthop. 1998 May-Jun;18(3):304-11.
PubMed 9600553Lundy C, Lumsden D, Fairhurst C. Treating complex movement disorders in children with cerebral palsy. Ulster Med J. 2009 Sep;78(3):157-63. No abstract available.
PubMed 19907680Im D, McDonald CM. New approaches to managing spasticity in children with cerebral palsy. West J Med. 1997 Apr;166(4):271. No abstract available.
PubMed 9168686Whelan MA, Delgado MR. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the quality standards subcommittee of the american academy of neurology and the practice committee of the child neurology society. Neurology. 2010 Aug 17;75(7):669. doi: 10.1212/WNL.0b013e3181ec670b. No abstract available.
PubMed 20713958Karadag-Saygi E, Kenis-Coskun O, Unalan PC, Evkaya-Acar A, Giray E, Akgulle AH. Pros and cons of botulinum toxin injection therapy in cerebral palsy: A qualitative study exploring caregivers' perspective. Child Care Health Dev. 2022 Jan;48(1):150-158. doi: 10.1111/cch.12915. Epub 2021 Oct 21.
PubMed 34623695
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy: A Qualitative Study Examining the Caregiver's Perspectives
- ClinicalTrials.gov ID
- NCT04256187
- Acronym / sponsor ID
- 09.2020.114
- Conditions
- Cerebral Palsy, Botulinum Toxin
- Keywords
- botulinum toxin, cerebral palsy, experiences, spasticity, caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Feb 2020 (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.
The aim of this study is to quantitatively record the opinions regarding the pros and cons of this treatment of the caregivers of children with cerebral palsy who had botulinum toxin applied in investigators' clinic.
Detailed description
Spasticity is defined as an increase in physiological resistance of the muscles associated with a lack of supraspinal inhibition against passive strain. It is a common and prohibitive problem associated with an increase in tendon reflex and tension reflex associated with upper motor neuron dysfunction. One of the most common problems in patients with CP.
Methods used in the treatment of spasticity; medical therapy, physical therapy, intrathecal baclofen pump, botulinum toxin injection, and orthopedic correction operations. However, botulinum toxin type-A (BTX-A) injections, which are applied to the muscles especially for localized spasticity, have become an effective adjuvant option that increases the effectiveness of classical methods and diversifies the treatment options.
BTX-A, which is basically a chemodenervation method; It is a treatment method that blocks the transmission of signal in the neuromuscular junction by preventing the release of acetylcholine vesicles into the presynaptic space. In spastic muscles, relaxation can be achieved by correct injection. Botulinum toxin type A has been shown to be an effective and safe treatment for children to reduce spasticity.
In Turkish society, there is no study evaluating the caregivers' experiences and opinions about botox treatments of patients with the diagnosis of cerebral palsy and limited studies in the literature are from countries with different sociodemographic features such as the United States and the United Kingdom. Although these patients have been receiving this treatment in investigators' center for years, there is no study in the literature that evaluates the plus and minus aspects of caregivers' experiences in this regard.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Other: Qualitative interviewCaregivers of children who treated with botulinum toxin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caregivers of children who treated with botulinum toxin.
Key inclusion criteria (2 listed)
- To be the caregiver of a patient under 18 years old with cerebral palsy
- No attempt has been made to reduce spasticity such as botulinum toxin injection in the last 3 months.
Key exclusion criteria (2 listed)
- Not knowing Turkish
- Refusing to participate in the study.
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 |
|---|---|---|
| Qualitative interviewQualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program. | Other | Healthy group |
Primary outcome
Experience of Botulinum toxin treatment
Time frame: Day 0
Qualitative interview performed at one occasion where the caregivers describes the experience about the their childrens' botulinum toxin treatment.
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 20 Jan 2021.
- Results publication: PubMed 8959462Barry MJ. Physical therapy interventions for patients with movement disorders due to cerebral palsy. J Child Neurol. 1996 Nov;11 Suppl 1:S51-60. doi: 10.1177/0883073896011001S08.
- Results publication: PubMed 9600553Corry IS, Cosgrove AP, Duffy CM, McNeill S, Taylor TC, Graham HK. Botulinum toxin A compared with stretching casts in the treatment of spastic equinus: a randomised prospective trial. J Pediatr Orthop. 1998 May-Jun;18(3):304-11.
- Results publication: PubMed 19907680Lundy C, Lumsden D, Fairhurst C. Treating complex movement disorders in children with cerebral palsy. Ulster Med J. 2009 Sep;78(3):157-63. No abstract available.
- Results publication: PubMed 9168686Im D, McDonald CM. New approaches to managing spasticity in children with cerebral palsy. West J Med. 1997 Apr;166(4):271. No abstract available.
- Results publication: PubMed 20713958Whelan MA, Delgado MR. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the quality standards subcommittee of the american academy of neurology and the practice committee of the child neurology society. Neurology. 2010 Aug 17;75(7):669. doi: 10.1212/WNL.0b013e3181ec670b. No abstract available.
- Derived from this study: PubMed 34623695Karadag-Saygi E, Kenis-Coskun O, Unalan PC, Evkaya-Acar A, Giray E, Akgulle AH. Pros and cons of botulinum toxin injection therapy in cerebral palsy: A qualitative study exploring caregivers' perspective. Child Care Health Dev. 2022 Jan;48(1):150-158. doi: 10.1111/cch.12915. Epub 2021 Oct 21.
- Individual participant dataSharing planned: Undecided
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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.
Ayca Evkaya, Res. Asst. principal investigator
Physiotherapy and Rehabilitation Department, Maltepe University
Ozge Kenis Coskun, Asts. Prof. principal investigator
Physical Medicine and Rehabilitation Department, Marmara University, Istanbul
Pemra Cobek Unalan, Prof principal investigator
Family Medicine Department, Marmara University, Istanbul
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 Cerebral Palsy and Botulinum Toxin, run by Marmara 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 2 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 20 Jan 2021. 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.
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?
Experience of Botulinum toxin treatment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256187, which also lists 6 linked publications.
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 20 Jan 2021.