Turkish Version of Hand-Use-at-Home Questionnaire

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04243590
Collaborator
(none)
67
1
16
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hand-Use-at-Home Questionnaire (HUH)
  • Behavioral: Pediatric Outcome Data Collection Instrument (PODCI)
  • Behavioral: Children's Hand-Use Experience Questionnaire (CHEQ)

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.

Study Design

Study Type:
Observational
Actual Enrollment :
67 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Jan 24, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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)
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).

Behavioral: Pediatric Outcome Data Collection Instrument (PODCI)
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).

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)
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).

Behavioral: Children's Hand-Use Experience Questionnaire (CHEQ)
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.

Outcome Measures

Primary Outcome Measures

  1. Hand-Use-at-Home Questionnaire [Day 0]

    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).

  2. Hand-Use-at-Home Questionnaire (HUH) [Day 7]

    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).

Secondary Outcome Measures

  1. Pediatric Outcome Data Collection Instrument (PODCI) [Day 0]

    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. 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) was used in this study since this scale provides information about difficulties performing activities using the arms/hands (score 0-100; lower score, more difficulties).

  2. Children's Hand-Use Experience Questionnaire (CHEQ/mini-CHEQ) [Day 0]

    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. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Istanbul Turkey 34890

Sponsors and Collaborators

  • Marmara University

Investigators

  • Study Director: Naime Evrim Karadag Saygi, Prof, Department of PM&R, Marmara University School of Medicine
  • Principal Investigator: Ayca Evkaya, Res. Asst., Department of Physiotherapy and Rehabilitation, Maltepe University
  • Principal Investigator: Ayse Simsek, PT (MSc), Department of Physiotherapy and Rehabilitation, Gazi University.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT04243590
Other Study ID Numbers:
  • 09.2018.712
First Posted:
Jan 28, 2020
Last Update Posted:
May 8, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2020