- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06887530
Hand-10 Questionnaire in Children With Unilateral Cerebral Palsy
Validity and Reliability of the Hand-10 Questionnaire in Children With Unilateral Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Gazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children between the ages of 6-15, diagnosed with unilateral cerebral palsy,
- With sufficient cognitive status to understand assessment instructions
- With reading skills
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Manual Ability Classification System
Time Frame: 1-3 months
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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.
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1-3 months
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Hand-10 questionnaire
Time Frame: 1-3 months
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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.
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1-3 months
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ABILHAND-kids questionnaire
Time Frame: 1-3 months
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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.
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1-3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia ZORLULAR, Gazi University
Publications and helpful links
General Publications
- Alhusaini 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.
- Anttila 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.
- Oksuz 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.
- Kurimoto 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.
- de 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.
- 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.
- Kurimoto 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.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hand-10 Questionnaire
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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