Musculoskeletal DiseasesNCT04556500
Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
An observational study of Musculoskeletal Diseases and Genetic Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to translate the Affordance in the Home Environment for Motor Development -Toddler (AHEMD-T) into Turkish and examine its psychometric properties. Read more about this study
- Who is it for?
- Ages 18 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases, Genetic Disease, Metabolic Disease
- What is being tested?
- investigating the psychometric properties of Turkish Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 15 Jan 2022
- 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 18 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Parent who have 18-42 months child * Volunteers
Who may be able to join
- Parent who have 18-42 months child
- Volunteers
Who cannot join
- Parents who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of the Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
This study aimed to translate the Affordance in the Home Environment for Motor Development -Toddler (AHEMD-T) into Turkish and examine its psychometric properties.
Read the detailed description
Child motor development is a complex process which results from the interaction between genetics and the environment. The role of the home as the first environment for child experiences is very important for motor development, especially during infancy. Thus, a more supportive and stimulating environment is associated with more affordances and challenges for infant motor development that may lead to improvement in social and cognitive development.
There is no Turkish questionnaire to evaluate home environment so we aimed to translate the AHEMD-T for using with Turkish children and to investigate psychometric properties.
- Being tested
- investigating the psychometric properties of Turkish Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
- Medical subject headings
- Musculoskeletal Diseases, Genetic Diseases, Inborn, Metabolic Diseases, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigating the psychometric properties of Turkish Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)Other
AHEMD-T will apply to parents who have 18-42 months child/children
What is being measured
The primary outcome is the main question the study is designed to answer.
Affordance in the Home Environment for Motor Development-Toddler (AHMED-T)
AHEMD-T consists 67 items with 5 section as outdoor environment, indoor environment, variety of stimulation, gross motor toys and fine motor toys. In addition to simple questions with yes-no responses or a Likert scale, this tool uses descriptive questions and visual examples to guide the respondent in the category of the toys provided. The total score of less than 10 was considered low and a poor assessment of affordance in the home environment. This meant that a few poor-quality opportunities were afforded in the home environment for child motor development. A score of 10-15 was a medium and sufficient assessment with adequate and suitable affordances in the home environment for child motor development. A score of 17-21 was considered high and reflected excellent opportunities in the home environment for child motor development.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge ÇANKAYA, Hacettepe University
- Investigators
- Ayşe Numanoğlu Akbaş, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556500
- Sponsor's protocol ID
- GO/12-2020
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hwang AW, Liao HF, Granlund M, Simeonsson RJ, Kang LJ, Pan YL. Linkage of ICF-CY codes with environmental factors in studies of developmental outcomes of infants and toddlers with or at risk for motor delays. Disabil Rehabil. 2014;36(2):89-104. doi: 10.3109/09638288.2013.777805. Epub 2013 Apr 17.
PubMed 23594061Carl G, Priscila M, Cacola. A New Inventory For Assessing Affordance in the Home environment For Motor Development. Early Childhood Edu J 2008;36(1):5-9.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
- ClinicalTrials.gov ID
- NCT04556500
- Acronym / sponsor ID
- GO/12-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to translate the Affordance in the Home Environment for Motor Development -Toddler (AHEMD-T) into Turkish and examine its psychometric properties.
Detailed description
Child motor development is a complex process which results from the interaction between genetics and the environment. The role of the home as the first environment for child experiences is very important for motor development, especially during infancy. Thus, a more supportive and stimulating environment is associated with more affordances and challenges for infant motor development that may lead to improvement in social and cognitive development.
There is no Turkish questionnaire to evaluate home environment so we aimed to translate the AHEMD-T for using with Turkish children and to investigate psychometric properties.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Parent who have 18-42 months child * Volunteers
Key inclusion criteria (2 listed)
- Parent who have 18-42 months child
- Volunteers
Key exclusion criteria (1 listed)
- Parents who are not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| investigating the psychometric properties of Turkish Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)AHEMD-T will apply to parents who have 18-42 months child/children | Other | – |
Primary outcome
Affordance in the Home Environment for Motor Development-Toddler (AHMED-T)
Time frame: 6 months
AHEMD-T consists 67 items with 5 section as outdoor environment, indoor environment, variety of stimulation, gross motor toys and fine motor toys. In addition to simple questions with yes-no responses or a Likert scale, this tool uses descriptive questions and visual examples to guide the respondent in the category of the toys provided. The total score of less than 10 was considered low and a poor assessment of affordance in the home environment. This meant that a few poor-quality opportunities were afforded in the home environment for child motor development. A score of 10-15 was a medium and sufficient assessment with adequate and suitable affordances in the home environment for child motor development. A score of 17-21 was considered high and reflected excellent opportunities in the home environment for child motor development.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 23594061Hwang AW, Liao HF, Granlund M, Simeonsson RJ, Kang LJ, Pan YL. Linkage of ICF-CY codes with environmental factors in studies of developmental outcomes of infants and toddlers with or at risk for motor delays. Disabil Rehabil. 2014;36(2):89-104. doi: 10.3109/09638288.2013.777805. Epub 2013 Apr 17.
- BackgroundCarl G, Priscila M, Cacola. A New Inventory For Assessing Affordance in the Home environment For Motor Development. Early Childhood Edu J 2008;36(1):5-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Numanoğlu Akbaş, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases and Genetic Disease, run by Hacettepe 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 2 inclusion and 1 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 22 Jun 2022. 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?
Affordance in the Home Environment for Motor Development-Toddler (AHMED-T) (time frame: 6 months). 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 NCT04556500, which also lists 2 linked publications.
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 22 Jun 2022.