Activity, MotorNCT05184244
Turkish Adaptation of the Activity Limitations in Cerebral Palsy Questionnaire
An observational study of Activity, Motor and Cerebral Palsy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. Eighty-nine individuals with CP, aged between 2-18 years were included in the study. PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM questionnaires were used for validity analysis. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Activity, Motor, Cerebral Palsy, Limitation, Mobility
- What is being tested?
- Activity Limitation Assessment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Nov 2021
- 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 2 to 18 years
- All sexes
- Child, Adult
Study population: children with CP aged between 2 and 18 years and their parents
Who may be able to join
- children with CP who were diagnosed by a child neurologist
- having physical therapy sessions at special education and rehabilitation center
- age between 2 and 18
Who cannot join
- whose parent was illiterate or doesn't speak Turkish
- whose parent wasn't complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Psychometric Properties of the Turkish Adaptation of the Activity Limitations in Cerebral Palsy Questionnaire
This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. Eighty-nine individuals with CP, aged between 2-18 years were included in the study. PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM questionnaires were used for validity analysis. Test re-test method was used for reliability.
Read the detailed description
Cerebral Palsy (CP) is a clinical picture with permanent disorders of the development of movement and posture whether assessing activity limitations matters. This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties.
The internal consistency of the scale was evaluated using Cronbach's alpha value and the inter-measurement reliability using the intraclass correlation coefficient (ICC). In construct validity analysis; ACTIVLIM-CP score; was correlated with PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM total scores. A known group comparison was made according to ambulation and epilepsy existence with the Principal Components Explanatory Factor Analysis.
- Conditions
- Activity, Motor, Cerebral Palsy, Limitation, Mobility
- Being tested
- Activity Limitation Assessment
- Keywords
- cerebral palsy, limitation, activity
- Medical subject headings
- Motor Activity, Cerebral Palsy, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Limitation AssessmentOther
The ACTIVLIM-CP scale evaluates the global activity performance and combined movements of the body.
| Study group | Role | What they receive |
|---|---|---|
| Participants with CP | Children with CP Receives: Other: Activity Limitation Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Activity Performance assessment
ACTIVLIM-CP: Caregiver rates the difficulty degree of 43 activities easy/difficult/impossible/unknown). Questionnaire scores between 0 and 86 points. A higher score shows better activity performance
Measured: 15 minutes
Secondary outcomes (5)
Gunctional capabilities and limitations
Gross Motor Function Classification System: It classifies the motor function of a child from level 1 (slightly affected) to level 5 (severely affected)
Measured: 5 minutes
Functional independence measurement
Functional Independence Measure for Children: The scale includes 18 measurement items and every item scores between 1 -7. A higher score shows more independence
Measured: 15 minutes
Child's ability to walk assessment
Abiloco-Kids: It consists of 10 questions for evaluating the walking performance from the viewpoint of the caregiver. Questionnaire scores between 0 and 20 points. A higher score shows better activity performance
Measured: 10 minutes
child's manual ability assessment
Abilhand-Kids: It consists of 21 questions to measure the manual ability from the viewpoint of the family. Questionnaire scores between 0 and 42 points. A higher score shows better activity performance.
Measured: 15 minutes
Functional assessment
Pediatric Evaluation of Disability Inventory (PEDI): It consists of three Functional Skills Scales, three Caregiver Assistance Scales, and three Modification Scales in the content areas of self-care, mobility, and social function. Functional Skills has 197 items and each item scores as 1(able) and 2(unable), Caregiver Assistance scores between 0(dependent) -5(independent) and Modifications assessing with frequencies .
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184244
- Sponsor's protocol ID
- IKC444
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kinik M, Naz I. An investigation of the psychometric properties of the Turkish adaptation of the activity limitations in cerebral palsy questionnaire. Disabil Rehabil. 2023 Aug;45(16):2668-2674. doi: 10.1080/09638288.2022.2099586. Epub 2022 Jul 22.
PubMed 35866563
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Psychometric Properties of the Turkish Adaptation of the Activity Limitations in Cerebral Palsy Questionnaire
- ClinicalTrials.gov ID
- NCT05184244
- Acronym / sponsor ID
- IKC444
- Conditions
- Activity, Motor, Cerebral Palsy, Limitation, Mobility
- Keywords
- cerebral palsy, limitation, activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 11 Jan 2022 (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 make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. Eighty-nine individuals with CP, aged between 2-18 years were included in the study. PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM questionnaires were used for validity analysis. Test re-test method was used for reliability.
Detailed description
Cerebral Palsy (CP) is a clinical picture with permanent disorders of the development of movement and posture whether assessing activity limitations matters. This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties.
The internal consistency of the scale was evaluated using Cronbach's alpha value and the inter-measurement reliability using the intraclass correlation coefficient (ICC). In construct validity analysis; ACTIVLIM-CP score; was correlated with PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM total scores. A known group comparison was made according to ambulation and epilepsy existence with the Principal Components Explanatory Factor Analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CP | – | Other: Activity Limitation AssessmentChildren with CP |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children with CP aged between 2 and 18 years and their parents
Key inclusion criteria (3 listed)
- children with CP who were diagnosed by a child neurologist
- having physical therapy sessions at special education and rehabilitation center
- age between 2 and 18
Key exclusion criteria (2 listed)
- whose parent was illiterate or doesn't speak Turkish
- whose parent wasn't complete the questionnaires
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 |
|---|---|---|
| Activity Limitation AssessmentThe ACTIVLIM-CP scale evaluates the global activity performance and combined movements of the body. | Other | Participants with CP |
Primary outcome
Global Activity Performance assessment
Time frame: 15 minutes
ACTIVLIM-CP: Caregiver rates the difficulty degree of 43 activities easy/difficult/impossible/unknown). Questionnaire scores between 0 and 86 points. A higher score shows better activity performance
5 secondary outcomes
Gunctional capabilities and limitations
Time frame: 5 minutes
Functional independence measurement
Time frame: 15 minutes
Child's ability to walk assessment
Time frame: 10 minutes
child's manual ability assessment
Time frame: 15 minutes
Functional assessment
Time frame: 20 minutes
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 25 Jan 2022.
- Derived from this study: PubMed 35866563Kinik M, Naz I. An investigation of the psychometric properties of the Turkish adaptation of the activity limitations in cerebral palsy questionnaire. Disabil Rehabil. 2023 Aug;45(16):2668-2674. doi: 10.1080/09638288.2022.2099586. Epub 2022 Jul 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Activity, Motor and Cerebral Palsy, run by Izmir Katip Celebi 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 3 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 25 Jan 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?
Global Activity Performance assessment (time frame: 15 minutes). 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 NCT05184244, 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 25 Jan 2022.