NCT06887530

Brief 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. Therefore, the aim of this planned study was to investigate the validity and reliability of the Hand-10 questionnaire in cerebral palsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 21, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 14, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

cerebral palsyhand functionsQuestionnaire validationDisability

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1-3 months

Study Arms (1)

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.

Other: Hand-10 questionnaire and ABILHAND-kids questionnaire

Interventions

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.

Unilateral Cerebral Palsy

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Children between the ages of 6-15, diagnosed with unilateral cerebral palsy,
  • With sufficient cognitive status to understand assessment instructions
  • With reading skills

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 21912917BACKGROUND
  • 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.

    PMID: 28715270BACKGROUND
  • 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.

    PMID: 28068864BACKGROUND
  • 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.

    PMID: 24641733BACKGROUND
  • 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.

    PMID: 22820834BACKGROUND
  • 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.

    PMID: 18435840BACKGROUND
  • 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.

    PMID: 30913943BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rabia ZORLULAR

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start

March 21, 2025

Primary Completion

May 20, 2025

Study Completion

May 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations