Clinical trial NCT06707831: Feasibility of the Trunk and Upper Extremity Assessments for Teleassessment in Children Cerebral Palsy
Official title: Investigation of the Feasibility of the Trunk and Upper Extremity Assessments Used in the Scope of the ICF for Tele-Assessment in Children with Hemiplegic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy (CP)
Keywords: teleassessment
telerehabilitation
trunk and upper extremity
cerebral palsy
reliability and validity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with cerebral palsy who visit the Pediatric Rehabilitation Department at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, for routine treatment or examination.

Brief summary: This study was conducted to investigate the suitability of trunk and upper extremity assessments used within the scope of the ICF for tele-assessment in children with hemiplegic cerebral palsy (CP).

Detailed description: A total of 36 children aged between 4-18 years with hemiplegic CP and their parents were included in the study. Children underwent evaluations on two occasions: one in face-to-face within a clinical setting, and the other through tele-assessment using video conferencing. This video conference session was recorded to be later reviewed and scored by two separate evaluators. For the assessment, the Trunk Control Measurement Scale (TCMS) was used for trunk control, the Upper Limb Physician Rating Scale (ULPRS) for upper extremity joint movement, the Upper Limb Selective Control Scale (SCUES) for selective ability, and the Quality of Upper Extremity Skills Test (QUEST) for skill quality. The bilateral hand use of children was assessed using the Abilhand-Kids, hemiplegic hand use with the Pediatric Motor Activity Log (PMAL), participation levels using The Assessment of Life-Habits (Life-H), and environmental factors were assessed using the European Child Environment Questionnaire (ECEQ), both face-to-face and through online surveys sent to families. Intra- and inter-rater reliability was determined by Intraclass Correlation Coefficient (ICC) and internal consistency was determined by Cronbach alpha coefficient (a). To determine validity, known group validity was examined based on the functional levels of children and concurrent validity was examined based on face-to-face assessment results. It was found that the internal consistency and both the intra- and inter-rater reliability of the TCMS (ICC: 0.82-0.91, p\<0.05; α: 0.88-0.91), SCUES (ICC: 0.93-0.97, p\<0.05; α: 0.93-0.94), ULPRS (ICC: 0.90-0.96, p\<0.05; α: 0.94-0.95), and QUEST (ICC: 0.86-0.93, p\<0.05; α: 0.93-0.94), conducted through both face-to-face assessment and tele-assessment by a physiotherapist or under supervision of a physiotherapist, were high to excellent. It was found that the tele-assessment reliability of Abilhand-Kids (ICC: 0.707, p\<0.05) and PMAL (ICC: 0.60-0.70, p\<0.05) was moderate; whereas, Life-H (ICC: 0.24) and ECEQ (ICC: 0.311) were determined to be weak. As a result, it was found that TCMS, SCUES, ULPRS, QUEST, Abilhand-Kids, and PMAL are suitable, valid, and reliable methods for tele-assessment; whereas, ECEQ and Life-H are not suitable for tele-assessment. These findings might partially diminish the necessity for the evaluation of children with CP in clinical settings, opening the way for suitable assessment methods. By ensuring equal opportunities for children with CP who cannot physically reach the clinic due to various reasons, reliable assessments can be conducted, contributing to the development of personalized tele-rehabilitation programs for the child. Although more extensive studies will be needed in the future, we expect transport costs to fall.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with unilateral (hemiplegic) cerebral palsy
* Being 4 - 18 years old
* Classified as Communication Function Classification System (CFCS) level 1 or 2
* Classified as Visual Function Classification System (VFCS) level 1 or 2
* Parents are able to read and write in Turkish

Exclusion Criteria:

* Diagnosed with epilepsy and active seizures in addition to CP
* Unable to use video call methods
* Refused to participate in the study
* Unable to co-operate during assessments
* The one who refused to continue with the assessments
* Those who had health problems during the assessments and could not continue the assessments

Primary outcomes:
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: 5 minutes
measure: Upper Limb Physician Rating Scale (ULPRS)
timeFrame: 5 minutes
measure: Selective Control of Upper Extremity Scale (SCUES)
timeFrame: 5 minutes
measure: Quality of Upper Extremity Skills Test (QUEST)
timeFrame: 5 minutes
Secondary outcomes:
measure: Abilhand-Kids
timeFrame: 5 minutes
measure: Pediatric Motor Activity Log (PMAL)
timeFrame: 5 minutes
measure: The Assessment of Life-Habits (Life-H)
timeFrame: 5 minutes
measure: European Child Environment Questionnaire (ECEQ)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
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