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Completed

NCT Number: NCT04256187

Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qualitative interview

Other

Qualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy: A Qualitative Study Examining the Caregiver's Perspectives

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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