Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy

Completed

• Conditions: Botulinum Toxin; Cerebral Palsy
• Interventions: Other: Qualitative interview

• Registration Number: NCT04256187
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Primary Completion: 2020-12-30
• Status Verified: 2021-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy group	Qualitative interview	Caregivers of children who treated with botulinum toxin.

Primary Outcome Measures

Name	Time	Method
Experience of Botulinum toxin treatment	Day 0	Qualitative interview performed at one occasion where the caregivers describes the experience about the their childrens' botulinum toxin treatment.

Trial Locations

Locations (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey