- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04904848
Turkish Version of the "Children's Assessment of Participation With Hands Scale
Cultural Adaptation, Validity and Reliability of the Turkish Version of the "Children's Assessment of Participation With Hands (CAP-H)" Scale in Children With Physical Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- Translation of the scale into the target language (forward translation)
- Review of the scale translated into the target language by an expert panel of 2 pediatric rehabilitation physiotherapists, who can speak both languages.
- Translation of the scale from the target language to the original language (back translation)
- Testing the translated scale and discussing its conceptual integrity
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Konyaalti
-
Antalya, Konyaalti, Turkey, 07070
- Akdeniz University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Assessment of Participation with Hands (CAP-H)" scale
Time Frame: 2 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Classification System
Time Frame: 1 week
|
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
|
Manual Assesment Classification System
Time Frame: 1 week
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sebahat Yaprak Cetin, Assoc, Akdeniz University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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