Clinical trial NCT04256187: Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy
Official title: Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy: A Qualitative Study Examining the Caregiver's Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Botulinum Toxin
Keywords: botulinum toxin
cerebral palsy
experiences
spasticity
caregivers
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Caregivers of children who treated with botulinum toxin.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Experience of Botulinum toxin treatment
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Physiotherapy and Rehabilitation Department, Maltepe University
name: Ayca Evkaya, Res. Asst.
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Medicine and Rehabilitation Department, Marmara University, Istanbul
name: Ozge Kenis Coskun, Asts. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Medicine Department, Marmara University, Istanbul
name: Pemra Cobek Unalan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.