Clinical trial NCT04243590: Turkish Version of Hand-Use-at-Home Questionnaire
Official title: Validity and Reliability of the Turkish Version of Hand-Use-at-Home Questionnaire in Children With Neonatal Brachial Plexus Palsy or Unilateral Cerebral Palsy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Brachial Plexus Palsy
Keywords: brachial plexus
unilateral cerebral palsy
hand function
child rehabilitation
upper extremity
hand use at home questionnaire
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 67
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 42 unilateral cerebral palsy patients and 25 brachial plexus palsy between 3 - 10 years of age.

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.

Detailed description: Cerebral Palsy (CP) is defined as a permanent but non-progressive disorder group that affects the developing fetal or infantile brain, leading to impairment in movement and posture, thereby limiting physical activity and participation. The prevalence of CP in society is around 0.21%. In a study conducted in Turkey, this ratio of 4.4 / 1000 live births has been reported. Motor disorders in CP often are accompanied by sensory, perceptual, cognitive, communicative and behavioral problems and secondary musculoskeletal problems.

Obstetric brachial plexus (OBP) injury is a common peripheral nerve injury in children. Its incidence is reported between 0.42 and 5.1 per 1000 live births. As the primary mechanism of injury, it is accepted that traction or compression of all or part of the brachial plexus.

In these patients, weakness in the upper extremity, long-term contractures, and difficulties in the use of the extremities occurs due to the damage of nerves. In both diseases, patients have difficulty in bimanual activities.

Many treatment methods focus on increasing the use of upper extremities of patients and ensuring their independence in daily life activities. There are many methods for evaluating the hand use performance of patients and the effectiveness of different treatment methods. However, these clinical evaluation methods often do not reflect the patient's performance at home, at school, in their daily living environments.

The "Hand Use at Home (HUH)" questionnaire, which was created to be evaluated by parents, was developed in 2017 for measuring and evaluating the spontaneous use time of unilateral paretic children aged 3-10 in the affected hand and arm daily life activities.

The validity and reliability of the questionnaire were determined in children with obstetric brachial plexus paralysis and unilateral SP.

The purpose of this study; The translation of the HUH questionnaire into Turkish is to investigate its cultural adaptation, validity, and test-retest reliability.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hand-Use-at-Home Questionnaire
timeFrame: Day 0
measure: Hand-Use-at-Home Questionnaire (HUH)
timeFrame: Day 7
Secondary outcomes:
measure: Pediatric Outcome Data Collection Instrument (PODCI)
timeFrame: Day 0
measure: Children's Hand-Use Experience Questionnaire (CHEQ/mini-CHEQ)
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Department of PM&R, Marmara University School of Medicine
name: Naime Evrim Karadag Saygi, Prof
role: STUDY_DIRECTOR
affiliation: Department of Physiotherapy and Rehabilitation, Maltepe University
name: Ayca Evkaya, Res. Asst.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physiotherapy and Rehabilitation, Gazi University.
name: Ayse Simsek, PT (MSc)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.