NCT04243590

Brief Summary

To investigate the validity and reliability of the Turkish Version of parent-rated Hand-Use-at- Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

January 24, 2020

Last Update Submit

February 28, 2023

Conditions

Keywords

brachial plexusunilateral cerebral palsyhand functionchild rehabilitationupper extremityhand use at home questionnaire

Outcome Measures

Primary Outcomes (2)

  • Hand-Use-at-Home Questionnaire

    The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/often = score 1, always = score 2).

    Day 0

  • Hand-Use-at-Home Questionnaire (HUH)

    The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/often = score 1, always = score 2).

    Day 7

Secondary Outcomes (2)

  • Pediatric Outcome Data Collection Instrument (PODCI)

    Day 0

  • Children's Hand-Use Experience Questionnaire (CHEQ/mini-CHEQ)

    Day 0

Study Arms (2)

Neonatal brachial plexus palsy

25 patients will be included. The level of the brachial plexus lesion will be recorded. Parents of all patients were asked to fill in the Turkish version of the "Hand-at-Home Questionnaire" and in addition, the upper extremity section of the Pediatric Outcomes Data Collection Instrument (PODCI) in patients with OBP.

Behavioral: Hand-Use-at-Home Questionnaire (HUH)Behavioral: Pediatric Outcome Data Collection Instrument (PODCI)

Unilateral cerebral palsy

25 patients will be included. The level of "Manual Ability Classification System (MACS)" will be recorded. Parents of all patients were asked to fill out the Turkish version of the "Hand-at-Home Questionnaire at Home", as well as the "Children's Hand-Use Experience Questionnaire (CHEQ)" in patients with CP.

Behavioral: Hand-Use-at-Home Questionnaire (HUH)Behavioral: Children's Hand-Use Experience Questionnaire (CHEQ)

Interventions

The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/ often = score 1, always = score 2). A sum score can be calculated (range 0-36).

Neonatal brachial plexus palsyUnilateral cerebral palsy

The PODCI is designed to assess different aspects of daily living in children with musculoskeletal disorders. It has excellent psychometric properties, and it is a widely accepted instrument to provide parent/patient-reported information about upper extremity functioning. A Dutch version is available and it is validated for children with neonatal brachial plexus palsy. It consists of 85 questions and five scale scores and one total score can be calculated (range for all scales and total score 0-100, higher scores indicating better functioning/quality of life). Only the Upper Extremity and Physical Function Scale (8 items) were used in this study since this scale provides information about difficulties performing activities using the arms/hands (score 0-100; lower score, more difficulties).

Neonatal brachial plexus palsy

The CHEQ is a questionnaire for children (aged 6-18) with unilateral functional limitations of hand use and is well validated for children with unilateral cerebral palsy. It was only partially validated for use in children with neonatal brachial plexus palsy and has not yet been used in studies. Therefore, it was not used in this group. The questionnaire consists of 29 bimanual activities, typically requiring the use of both hands. It assesses the child's experience using their affected hand when performing the activities and counts how many of the activities are executed independently (with and without using the affected hand). In the mini-version of the CHEQ some items were deleted or replaced (with more age-appropriate activities for children aged three to eight years) and this version was used for all unilateral cerebral palsy children \<six years in this study.

Unilateral cerebral palsy

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

42 unilateral cerebral palsy patients and 25 brachial plexus palsy between 3 - 10 years of age.

You may qualify if:

  • Confirmed diagnosis of unilateral cerebral palsy or obstetric brachial plexus palsy
  • Age between 3 - 10
  • Volunteer to study

You may not qualify if:

  • Having a visual disorder
  • History of botulinum toxin injection and surgery for upper extremity and hand in the last 6 months.
  • Having robotic rehabilitation or intensive treatments such as constraint-induced movement therapy to increase upper extremity use in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (5)

  • Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  • Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.

  • Andersen J, Watt J, Olson J, Van Aerde J. Perinatal brachial plexus palsy. Paediatr Child Health. 2006 Feb;11(2):93-100. doi: 10.1093/pch/11.2.93.

  • Brandao M, Ocarino JM, Bueno KM, Mancini MC. Hand use at home and in clinical settings by children with cerebral palsy: a qualitative study. Occup Ther Int. 2015 Mar;22(1):43-50. doi: 10.1002/oti.1383. Epub 2014 Oct 29.

  • van der Holst M, Geerdink Y, Aarts P, Steenbeek D, Pondaag W, Nelissen RG, Geurts AC, Vliet Vlieland TP. Hand-Use-at-Home Questionnaire: validity and reliability in children with neonatal brachial plexus palsy or unilateral cerebral palsy. Clin Rehabil. 2018 Oct;32(10):1363-1373. doi: 10.1177/0269215518775156. Epub 2018 May 13.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Naime Evrim Karadag Saygi, Prof

    Department of PM&R, Marmara University School of Medicine

    STUDY DIRECTOR
  • Ayca Evkaya, Res. Asst.

    Department of Physiotherapy and Rehabilitation, Maltepe University

    PRINCIPAL INVESTIGATOR
  • Ayse Simsek, PT (MSc)

    Department of Physiotherapy and Rehabilitation, Gazi University.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

February 1, 2020

Primary Completion

January 24, 2021

Study Completion

January 1, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations