Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256187
• Other study ID #: 09.2020.114
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 1, 2021
• Est. primary completion date: December 30, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Botulinum Toxin
• Cerebral Palsy
• Paralysis

Intervention

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

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Barry MJ. Physical therapy interventions for patients with movement disorders due to cerebral palsy. J Child Neurol. 1996 Nov;11 Suppl 1:S51-60. Review. — View 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. — View Citation

Im D, McDonald CM. New approaches to managing spasticity in children with cerebral palsy. West J Med. 1997 Apr;166(4):271. — View 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experience of Botulinum toxin treatment	Qualitative interview performed at one occasion where the caregivers describes the experience about the their childrens' botulinum toxin treatment.	Day 0