Cerebral Palsy (CP)NCT06887530
Hand-10 Questionnaire in Children With Unilateral Cerebral Palsy
An observational study of Cerebral Palsy (CP) and Hand Functions, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
A Turkish version of the Hand-10 (unabbreviated) questionnaire has been developed, but its validity and reliability in cerebral palsy has not yet been proven. In particular, questioning daily life activities with visual content can make a significant contribution to evaluating hand functions and independence. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy (CP), Hand Functions
- What is being tested?
- Hand-10 questionnaire and ABILHAND-kids questionnaire
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2025to 30 May 2025
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between the ages of 6 and 15 who have been diagnosed with unilateral cerebral palsy and who have sufficient cognitive status to understand assessment instructions and reading skills will be included.
Who may be able to join
- Children between the ages of 6-15, diagnosed with unilateral cerebral palsy,
- With sufficient cognitive status to understand assessment instructions
- With reading skills
Who cannot join
- Those with health problems not related to cerebral palsy,
- neglect of the affected extremity,
- serious visual problems,
- undergoing botox or orthopedic surgery in the last 6 months,
- not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of the Hand-10 Questionnaire in Children With Unilateral Cerebral Palsy
A Turkish version of the Hand-10 (unabbreviated) questionnaire has been developed, but its validity and reliability in cerebral palsy has not yet been proven. In particular, questioning daily life activities with visual content can make a significant contribution to evaluating hand functions and independence. Therefore, the aim of this planned study was to investigate the validity and reliability of the Hand-10 questionnaire in cerebral palsy.
Read the detailed description
The Hand-10 questionnaire was developed to evaluate upper extremity problems. It is a clear, short, and visual questionnaire that the individual fills out on their own. It includes shoulder, elbow, wrist, and hand functions. The developers of the questionnaire stated that it can be easily applied to children due to its visual explanations. Pictorial materials make the survey more understandable for the elderly and children. Visual content makes participation more enjoyable, especially for children. Due to its visual content, Hand10 has been proven to be applicable to the elderly and children. For its high accuracy, it is recommended to analyze its validity in specific diseases in previous studies. However, there are only two studies to date that have shown its validity for patients with lateral epicondylitis and trigger finger. Due to its clarity and visuals, it can make a significant contribution to the assessment methods used especially in children with cerebral palsy. Therefore, investigating its validity and reliability in children with cerebral palsy can provide support to the literature and professionals working in this field.
- Conditions
- Cerebral Palsy (CP), Hand Functions
- Being tested
- Hand-10 questionnaire and ABILHAND-kids questionnaire
- Keywords
- cerebral palsy, hand functions, Questionnaire validation, Disability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-10 questionnaire and ABILHAND-kids questionnaireOther
Children and their parents included in the study will be informed about the purpose of the study and the evaluations to be made and will be asked to sign a written consent form. The questions in the data collection form will be asked to individuals in a face-to-face interview. The manual skills classification system, Hand-10 questionnaire and ABILHAND-kids questionnaire will be used.
While validating the Hand10 questionnaire in children with cerebral palsy, it was planned to use the ABILHAND-kids scale, which has been previously validated for reliability and validity in cerebral palsy. It was also planned to use the hand function classification system in the evaluations. The Hand-10 questionnaire will be filled out by the child himself. The ABILHAND-kids questionnaire will be filled out by the parent. An expert will record the manuel ability system according to the hand skills.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Cerebral Palsy | Children between the ages of 6-15, diagnosed with unilateral cerebral palsy, with sufficient cognitive status to understand the evaluation commands and with reading skills will be included. Receives: Other: Hand-10 questionnaire and ABILHAND-kids questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Ability Classification System
The Manual Ability Classification System is a classification system that evaluates the hand-use skills of children with Cerebral palsy between the ages of 4 and 18 in their daily activities. It evaluates how the child holds objects on his/her own and the extent to which he/she needs assistance and adaptation when performing various functions using his/her hand in his/her daily life. It measures the general capacity to hold objects. It focuses on how the child holds objects appropriate for his/her age, regardless of the difference in function between the two hands. While Level I is the best in terms of manual skills, Level V represents the least adequate situation.
Measured: 1-3 months
Hand-10 questionnaire
The Hand-10 (unabbreviated) questionnaire consists of 10 items. It was developed to evaluate upper extremity problems. It is a clear, short questionnaire with visual elements. It includes shoulder, elbow, wrist and hand functions. Hand-10 questionnaire assesses complaints related to hand disorders with 10 items. Patients rate their performance over the past week on a scale from 0 to 10 (0: no limitation, 10: impossible), with total scores ranging from 0 to 100. Higher scores indicate worse functional status.The presence of visual explanations allows easy application for children and the elderly. The Hand-10 questionnaire has been used to evaluate the results of lateral epicondylitis treatment and cases with carpal tunnel syndrome.
Measured: 1-3 months
ABILHAND-kids questionnaire
ABILHAND-Kids questionnaire is a valid and reliable questionnaire developed to assess the perceived manual skills of children with cerebral palsy or their parents. It is used in children aged 6-15. The questionnaire assesses a person's daily life activities that require upper extremity function. It consists of 21 items. Each item is evaluated between 0 and 2 points (0: impossible, 1: difficult, 2: easy). A higher score indicates better upper extremity function. There is a Turkish version of the ABILHAND-kids questionnaire.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start21 Mar 2025
- Primary completion20 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Gazi University
- Investigators
- Rabia ZORLULAR, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887530
- Sponsor's protocol ID
- Hand-10 Questionnaire
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moritomo H, Imaeda T, Gotani H, Momose T, Abe Y, Oi H, Omokawa S, Sawaizumi T, Nemoto K; Functional Evaluation Committee of Japanese Society for Surgery of Hand. Reliability of the Hand20 questionnaire: comparison with the 36-Item Short-Form Health Survey. Hand Surg. 2014;19(1):1-6. doi: 10.1142/S0218810414500014.
PubMed 24641733Kurimoto S, Yamamoto M, Shinohara T, Tatebe M, Katsuyuki I, Hirata H. Favorable effects of explanatory illustrations attached to a self-administered questionnaire for upper extremity disorders. Qual Life Res. 2013 Jun;22(5):1145-9. doi: 10.1007/s11136-012-0233-4. Epub 2012 Jul 22.
PubMed 22820834Anttila H, Autti-Ramo I, Suoranta J, Makela M, Malmivaara A. Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC Pediatr. 2008 Apr 24;8:14. doi: 10.1186/1471-2431-8-14.
PubMed 18435840Alhusaini AA, Fallatah S, Melam GR, Buragadda S. Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosens Mot Res. 2019 Mar;36(1):49-55. doi: 10.1080/08990220.2019.1584555. Epub 2019 Mar 26.
PubMed 30913943Kurimoto S, Suzuki M, Yamamoto M, Okui N, Imaeda T, Hirata H. Development and validation of a ten-item questionnaire with explanatory illustrations to assess upper extremity disorders: favorable effect of illustrations in the item reduction process. J Orthop Sci. 2011 Nov;16(6):737-44. doi: 10.1007/s00776-011-0148-x. Epub 2011 Sep 10.
PubMed 21912917Oksuz C, Alemdaroglu I, Kilinc M, Abaoglu H, Demirci C, Karahan S, Yilmaz O, Yildirim SA. Reliability and validity of the Turkish version of ABILHAND-Kids' questionnaire in a group of patients with neuromuscular disorders. Physiother Theory Pract. 2017 Oct;33(10):780-787. doi: 10.1080/09593985.2017.1346026. Epub 2017 Jul 17.
PubMed 28715270de Jong LD, van Meeteren A, Emmelot CH, Land NE, Dijkstra PU. Reliability and sources of variation of the ABILHAND-Kids questionnaire in children with cerebral palsy. Disabil Rehabil. 2018 Mar;40(6):684-689. doi: 10.1080/09638288.2016.1272139. Epub 2017 Jan 9.
PubMed 28068864
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Hand-10 Questionnaire in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06887530
- Acronym / sponsor ID
- Hand-10 Questionnaire
- Conditions
- Cerebral Palsy (CP), Hand Functions
- Keywords
- cerebral palsy, hand functions, Questionnaire validation, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 20 Mar 2025 (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.
A Turkish version of the Hand-10 (unabbreviated) questionnaire has been developed, but its validity and reliability in cerebral palsy has not yet been proven. In particular, questioning daily life activities with visual content can make a significant contribution to evaluating hand functions and independence. Therefore, the aim of this planned study was to investigate the validity and reliability of the Hand-10 questionnaire in cerebral palsy.
Detailed description
The Hand-10 questionnaire was developed to evaluate upper extremity problems. It is a clear, short, and visual questionnaire that the individual fills out on their own. It includes shoulder, elbow, wrist, and hand functions. The developers of the questionnaire stated that it can be easily applied to children due to its visual explanations. Pictorial materials make the survey more understandable for the elderly and children. Visual content makes participation more enjoyable, especially for children. Due to its visual content, Hand10 has been proven to be applicable to the elderly and children. For its high accuracy, it is recommended to analyze its validity in specific diseases in previous studies. However, there are only two studies to date that have shown its validity for patients with lateral epicondylitis and trigger finger. Due to its clarity and visuals, it can make a significant contribution to the assessment methods used especially in children with cerebral palsy. Therefore, investigating its validity and reliability in children with cerebral palsy can provide support to the literature and professionals working in this field.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral Cerebral Palsy | – | Other: Hand-10 questionnaire and ABILHAND-kids questionnaireChildren between the ages of 6-15, diagnosed with unilateral cerebral palsy, with sufficient cognitive status to understand the evaluation commands and with reading skills will be included. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between the ages of 6 and 15 who have been diagnosed with unilateral cerebral palsy and who have sufficient cognitive status to understand assessment instructions and reading skills will be included.
Key inclusion criteria (3 listed)
- Children between the ages of 6-15, diagnosed with unilateral cerebral palsy,
- With sufficient cognitive status to understand assessment instructions
- With reading skills
Key exclusion criteria (5 listed)
- Those with health problems not related to cerebral palsy,
- neglect of the affected extremity,
- serious visual problems,
- undergoing botox or orthopedic surgery in the last 6 months,
- 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 |
|---|---|---|
| Hand-10 questionnaire and ABILHAND-kids questionnaireChildren and their parents included in the study will be informed about the purpose of the study and the evaluations to be made and will be asked to sign a written consent form. The questions in the data collection form will be asked to individuals in a face-to-face interview. The manual skills classification system, Hand-10 questionnaire and ABILHAND-kids questionnaire will be used. While validating the Hand10 questionnaire in children with cerebral palsy, it was planned to use the ABILHAND-kids scale, which has been previously validated for reliability and validity in cerebral palsy. It was also planned to use the hand function classification system in the evaluations. The Hand-10 questionnaire will be filled out by the child himself. The ABILHAND-kids questionnaire will be filled out by the parent. An expert will record the manuel ability system according to the hand skills. | Other | Unilateral Cerebral Palsy |
Primary outcome
Manual Ability Classification System
Time frame: 1-3 months
The Manual Ability Classification System is a classification system that evaluates the hand-use skills of children with Cerebral palsy between the ages of 4 and 18 in their daily activities. It evaluates how the child holds objects on his/her own and the extent to which he/she needs assistance and adaptation when performing various functions using his/her hand in his/her daily life. It measures the general capacity to hold objects. It focuses on how the child holds objects appropriate for his/her age, regardless of the difference in function between the two hands. While Level I is the best in terms of manual skills, Level V represents the least adequate situation.
Hand-10 questionnaire
Time frame: 1-3 months
The Hand-10 (unabbreviated) questionnaire consists of 10 items. It was developed to evaluate upper extremity problems. It is a clear, short questionnaire with visual elements. It includes shoulder, elbow, wrist and hand functions. Hand-10 questionnaire assesses complaints related to hand disorders with 10 items. Patients rate their performance over the past week on a scale from 0 to 10 (0: no limitation, 10: impossible), with total scores ranging from 0 to 100. Higher scores indicate worse functional status.The presence of visual explanations allows easy application for children and the elderly. The Hand-10 questionnaire has been used to evaluate the results of lateral epicondylitis treatment and cases with carpal tunnel syndrome.
ABILHAND-kids questionnaire
Time frame: 1-3 months
ABILHAND-Kids questionnaire is a valid and reliable questionnaire developed to assess the perceived manual skills of children with cerebral palsy or their parents. It is used in children aged 6-15. The questionnaire assesses a person's daily life activities that require upper extremity function. It consists of 21 items. Each item is evaluated between 0 and 2 points (0: impossible, 1: difficult, 2: easy). A higher score indicates better upper extremity function. There is a Turkish version of the ABILHAND-kids questionnaire.
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 Jun 2025.
- Background: PubMed 24641733Moritomo H, Imaeda T, Gotani H, Momose T, Abe Y, Oi H, Omokawa S, Sawaizumi T, Nemoto K; Functional Evaluation Committee of Japanese Society for Surgery of Hand. Reliability of the Hand20 questionnaire: comparison with the 36-Item Short-Form Health Survey. Hand Surg. 2014;19(1):1-6. doi: 10.1142/S0218810414500014.
- Background: PubMed 22820834Kurimoto S, Yamamoto M, Shinohara T, Tatebe M, Katsuyuki I, Hirata H. Favorable effects of explanatory illustrations attached to a self-administered questionnaire for upper extremity disorders. Qual Life Res. 2013 Jun;22(5):1145-9. doi: 10.1007/s11136-012-0233-4. Epub 2012 Jul 22.
- Background: PubMed 18435840Anttila H, Autti-Ramo I, Suoranta J, Makela M, Malmivaara A. Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC Pediatr. 2008 Apr 24;8:14. doi: 10.1186/1471-2431-8-14.
- Background: PubMed 30913943Alhusaini AA, Fallatah S, Melam GR, Buragadda S. Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosens Mot Res. 2019 Mar;36(1):49-55. doi: 10.1080/08990220.2019.1584555. Epub 2019 Mar 26.
- Results publication: PubMed 21912917Kurimoto S, Suzuki M, Yamamoto M, Okui N, Imaeda T, Hirata H. Development and validation of a ten-item questionnaire with explanatory illustrations to assess upper extremity disorders: favorable effect of illustrations in the item reduction process. J Orthop Sci. 2011 Nov;16(6):737-44. doi: 10.1007/s00776-011-0148-x. Epub 2011 Sep 10.
- Results publication: PubMed 28715270Oksuz C, Alemdaroglu I, Kilinc M, Abaoglu H, Demirci C, Karahan S, Yilmaz O, Yildirim SA. Reliability and validity of the Turkish version of ABILHAND-Kids' questionnaire in a group of patients with neuromuscular disorders. Physiother Theory Pract. 2017 Oct;33(10):780-787. doi: 10.1080/09593985.2017.1346026. Epub 2017 Jul 17.
- Results publication: PubMed 28068864de Jong LD, van Meeteren A, Emmelot CH, Land NE, Dijkstra PU. Reliability and sources of variation of the ABILHAND-Kids questionnaire in children with cerebral palsy. Disabil Rehabil. 2018 Mar;40(6):684-689. doi: 10.1080/09638288.2016.1272139. Epub 2017 Jan 9.
- Individual participant dataSharing planned: No
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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.
Rabia ZORLULAR principal investigator
Gazi 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 Cerebral Palsy (CP) and Hand Functions, run by Gazi 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 5 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 Jun 2025. 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?
Manual Ability Classification System (time frame: 1-3 months). The study lists 3 primary outcomes in all. 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 NCT06887530, which also lists 7 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 25 Jun 2025.