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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03195335
Other study ID # 116S359
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date August 1, 2018

Study information

Verified date August 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- To be diagnosed as cerebral palsy

Exclusion Criteria:

- Children whose family didn't accept to participate to study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment via questionnaire
All the children will be assessed via assessment questionnaires.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (2)

Lead Sponsor Collaborator
Hacettepe University Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Abel MF, Damiano DL, Gilgannon M, Carmines D, Kang HG, Bennett BC, Laws ER Jr. Biomechanical changes in gait following selective dorsal rhizotomy. J Neurosurg. 2005 Mar;102(2 Suppl):157-62. — View Citation

Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.

Outcome

Type Measure Description Time frame Safety issue
Primary Life Habits Questionnaire (LIFE-H) Assessing of the participation level of children At baseline
Secondary Gross Motor Function Classification System (GMFCS) Assessing severity of the disability of children At baseline
Secondary Pediatric Outcomes Date Collection (PODCI) (Questionnaire) Assessing health-related quality of life of children by parent proxy questionnaire At baseline
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