Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy
NCT ID: NCT04256187
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2019-11-01
2021-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy group
Caregivers of children who treated with botulinum toxin.
Qualitative interview
Qualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program.
Interventions
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Qualitative interview
Qualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program.
Eligibility Criteria
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Inclusion Criteria
* No attempt has been made to reduce spasticity such as botulinum toxin injection in the last 3 months.
Exclusion Criteria
* Refusing to participate in the study.
18 Years
65 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Ayca Evkaya, Res. Asst.
Role: PRINCIPAL_INVESTIGATOR
Physiotherapy and Rehabilitation Department, Maltepe University
Ozge Kenis Coskun, Asts. Prof.
Role: PRINCIPAL_INVESTIGATOR
Physical Medicine and Rehabilitation Department, Marmara University, Istanbul
Pemra Cobek Unalan, Prof
Role: PRINCIPAL_INVESTIGATOR
Family Medicine Department, Marmara University, Istanbul
Locations
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Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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09.2020.114
Identifier Type: -
Identifier Source: org_study_id
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