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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04904848
Other study ID # 2019-192
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date December 20, 2019

Study information

Verified date May 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To the best of our knowledge, there is no Turkish validity and reliability scale that can reveal children's hand involvement. In the study in which the CAP-H was developed, it was stated that this scale could be used in population-level research studies to examine the similarities and differences in children's manual life participation among different diagnosis groups. It is very important to adapt translated assessment tools to different cultures and languages and to verify their reliability and validity. Moreover, self-report questionnaires are advantageous in that they can be used for large-scale testing. The aim of this study was to examine the convergent validity and reliability of a Turkish version of the "Children's Assessment of Participation with Hands (CAP-H)" scale in order to evaluate the hand participation of physically disabled children.


Description:

The CAP-H scale was used to evaluate children's hand participation and to examine the validity and reliability of the Turkish version. The original scale was developed by Chien et al. in Australia in 2015 to evaluate the difficulties experienced by children aged 2-12 years in using the hands in daily living activities that require hand participation. In the adaptation of the CAP-H to Turkish, the standard protocol of the WHO for the adaptation of the scales to different languages was applied: 1. Translation of the scale into the target language (forward translation) 2. Review of the scale translated into the target language by an expert panel of 2 pediatric rehabilitation physiotherapists, who can speak both languages. 3. Translation of the scale from the target language to the original language (back translation) 4. Testing the translated scale and discussing its conceptual integrity 5. Final version of the adapted scale (final version) For validity of CAP-H, Gross Motor Function Classification System and Manual Assesment Classification System scales used.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date December 20, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 12 Years
Eligibility Inclusion Criteria: - voluntary participation in the study, - having a physical disability report, - the evaluated child in the age range of 2-12 years, and - the respondent (child or parent) to be Turkish literate Exclusion Criteria: - Do not want to participate in the study - Not completing surveys

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey evaluation
examine the convergent validity and reliability of a Turkish version

Locations

Country Name City State
Turkey Akdeniz University Antalya Konyaalti

Sponsors (2)

Lead Sponsor Collaborator
Pamukkale University Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Chien CW, Rodger S, Copley J. Development and Psychometric Evaluation of a New Measure for Children's Participation in Hand-Use Life Situations. Arch Phys Med Rehabil. 2015 Jun;96(6):1045-55. doi: 10.1016/j.apmr.2014.11.013. Epub 2014 Nov 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Children's Assessment of Participation with Hands (CAP-H)" scale The original scale was developed by Chien et al. in 2015 to evaluate the difficulties experienced by children aged 2-12 years in using the hands in daily living activities that require hand participation. The scale consists of 32 items in 4 sections: self-care participation (9 items), recreational participation (11 items), educational participation (8 items), and domestic life and community participation (9 items). Each section has 4 sub-scores of difference, frequency, independence and desire to change sections, scored with Likert-type responses, and higher scores indicate higher hand participation. The percentage score is obtained by dividing the total score by the number of items marked in the sub-scores of difference and change request. In frequency and independence scoring, the score is obtained by dividing the total score by the number of items marked. 2 week
Secondary Gross Motor Function Classification System The (GMFCS), developed for children, is a classification system based on the child's self-initiated movements with an emphasis on sitting, displacement and mobility. Since the motor functions of children vary depending on age, functions for each age group are defined for each level, including children under 2 years old, between 2 and 4 years old, between 4 and 6 years old, and between 6 and 12 years old. While it was previously used for children under the age of 12 years, it can now be used for young people between the ages of 12 and 18 years in its expanded form.
GMFCS levels according to age Level I: walks without restrictions Level II: Walks with restrictions Level III: Walks using hand-held mobility aids Level IV: Self-movement is restricted; can use motor mobility vehicle. Level V: Transported in a hand-pushed wheelchair
1 week
Secondary Manual Assesment Classification System The Manual Assesment Classification System (MACS) is used to classify children's ability to hold objects in daily activities. Turkish validity and reliability studies have been conducted. While MACS evaluates the participation of both hands together in activities, it cannot evaluate the hands separately. The classification is graded as follows:
I - Holds objects easily and successfully. II- Can hold many objects, but the speed and / or quality of achievement is somewhat reduced.
III- Holds objects with difficulty; help is needed in modifying and / or organizing activities.
IV- Holds a selected limited number of objects easily arranged in adapted situations.
V- Cannot hold objects and has severely limited ability to perform even a simple action.
1 week
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