- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04256187
Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy
Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy: A Qualitative Study Examining the Caregiver's Perspectives
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34890
- Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not knowing Turkish
- Refusing to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthy group
Caregivers of children who treated with botulinum toxin.
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Qualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience of Botulinum toxin treatment
Time Frame: Day 0
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Qualitative interview performed at one occasion where the caregivers describes the experience about the their childrens' botulinum toxin treatment.
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Day 0
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayca Evkaya, Res. Asst., Physiotherapy and Rehabilitation Department, Maltepe University
- Principal Investigator: Ozge Kenis Coskun, Asts. Prof., Physical Medicine and Rehabilitation Department, Marmara University, Istanbul
- Principal Investigator: Pemra Cobek Unalan, Prof, Family Medicine Department, Marmara University, Istanbul
Publications and helpful links
General 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.
- Corry 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.
- Lundy 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.
- Im D, McDonald CM. New approaches to managing spasticity in children with cerebral palsy. West J Med. 1997 Apr;166(4):271. No abstract available.
- Whelan 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.
- Karadag-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2020.114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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