NCT04256187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

February 3, 2020

Last Update Submit

January 17, 2021

Conditions

Cerebral PalsyBotulinum Toxin

Keywords

botulinum toxincerebral palsyexperiencesspasticitycaregivers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Healthy group

Caregivers of children who treated with botulinum toxin.

Other: Qualitative interview

Interventions

Qualitative interviewOTHER

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

Healthy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Caregivers of children who treated with botulinum toxin.

You may qualify if:

  • 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.

You may not qualify if:

  • Not knowing Turkish
  • Refusing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 8959462RESULT

  • 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.

    PMID: 9600553RESULT

  • 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.

    PMID: 19907680RESULT

  • 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.

    PMID: 9168686RESULT

  • 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.

    PMID: 20713958RESULT

  • 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.

    PMID: 34623695DERIVED

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayca Evkaya, Res. Asst.

    Physiotherapy and Rehabilitation Department, Maltepe University

    PRINCIPAL INVESTIGATOR

  • Ozge Kenis Coskun, Asts. Prof.

    Physical Medicine and Rehabilitation Department, Marmara University, Istanbul

    PRINCIPAL INVESTIGATOR

  • Pemra Cobek Unalan, Prof

    Family Medicine Department, Marmara University, Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

November 1, 2019

Primary Completion

December 30, 2020

Study Completion

January 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

TU(1)