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Participation, PatientNCT04904848

Turkish Version of the "Children's Assessment of Participation With Hands Scale

An observational study of Participation, Patient and Child, Only, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Participation, Patient, Child, Only
What is being tested?
Survey evaluation
How many people
182 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2019to 20 Dec 2019
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with physical disability

Who may be able to join

  • 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

Who cannot join

  • Do not want to participate in the study
  • Not completing surveys

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Akdeniz University

    Antalya, Konyaalti, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read the 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:

  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.

Being tested
Survey evaluation
Keywords
validity, reliability, children, participation, hand
Medical subject headings
Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Survey evaluationOther

    examine the convergent validity and reliability of a Turkish version

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 week

Secondary outcomes (2)

  1. 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

    Measured: 1 week

  2. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start15 May 2019
  3. Primary completion1 Dec 2019
  4. Study completion20 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
182 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04904848
Sponsor's protocol ID
2019-192
Status last verified
May 2021
First submitted
24 May 2021
Last updated
27 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will share our data with other researchers by Statistical Package Program

Publications

  • 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.

    PubMed 25437107

Questions about this trial

What is this clinical trial studying?

An observational study of Participation, Patient and Child, Only, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's Assessment of Participation with Hands (CAP-H)" scale (time frame: 2 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04904848, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.

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