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Cerebral Palsy (CP)NCT06707831

Feasibility of the Trunk and Upper Extremity Assessments for Teleassessment in Children Cerebral Palsy

An observational study of Cerebral Palsy (CP), run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
Teleassessment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2022to 1 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

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

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).

Read the 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.

Being tested
Teleassessment
Keywords
teleassessment, telerehabilitation, trunk and upper extremity, cerebral palsy, reliability and validity
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeleassessmentOther

    Children underwent assessments on two occasions: one in face-to-face within a clinical setting, and the other through teleassessment using video conferencing. This video conference session was recorded to be later reviewed and scored by two separate raters.

Study groups in NCT06707831
Study groupRoleWhat they receive
Study sampleChildren with hemiplegic cerebral palsy aged 4 to 18 years
Receives: Other: Teleassessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trunk Control Measurement Scale (TCMS)

    The TCMS is a clinical tool used to assess trunk control in children with cerebral palsy. It evaluates both static and dynamic aspects of trunk control through tasks divided into three subscales: static sitting balance, dynamic sitting balance and dynamic reaching. It has total 15 items and each item is scored on a scale of 0 to 3, where higher scores indicate better trunk control. The total score ranges from 0 to 58, with subscale scores providing insights into specific components of trunk function.

    Measured: 5 minutes

  2. Upper Limb Physician Rating Scale (ULPRS)

    The ULPRS is a clinical assessment tool used to evaluate upper limb function in individuals with conditions like cerebral palsy. It focuses on assessing movement quality, range of motion, and functional use of the upper extremities during specific tasks or movements. The scoring typically reflects the severity of impairment, with lower scores indicating greater functional limitations. It is commonly used to monitor progress and guide treatment planning. Typically, items are scored individually, and the total score represents the overall severity of impairment or functionality.

    Measured: 5 minutes

  3. Selective Control of Upper Extremity Scale (SCUES)

    The SCUES is a clinical assessment tool designed to measure selective motor control in the upper extremities, particularly in individuals with neurological conditions such as cerebral palsy. It evaluates the ability to perform isolated, precise movements in the shoulder, elbow, wrist, and fingers without using compensatory patterns. Each limb is scored on a scale from 0 to 3 for each joint, where 0 indicates no selective movement and 3 indicates completely selective movement. The total score for a limb ranges from 0 to 15, with higher scores reflecting greater selectivity.

    Measured: 5 minutes

  4. Quality of Upper Extremity Skills Test (QUEST)

    The QUEST is a standardized tool designed to assess upper extremity function in children with neuromotor impairments, particularly cerebral palsy. It evaluates four domains: dissociated movements, grasp, protective extension, and weight-bearing, with 36 items scored from 0 (cannot perform) to 2 (performs fully). The scores are summed for each domain, and a total percentage score is calculated, with higher scores reflecting better movement quality and function. The QUEST is useful for guiding therapy and tracking progress over time.

    Measured: 5 minutes

Secondary outcomes (4)

  1. Abilhand-Kids

    The Abilhand-Kids is a parent-reported questionnaire designed to assess manual ability in children with upper limb impairments, particularly those with cerebral palsy or other developmental disabilities. It measures the child's ability to perform daily activities requiring the use of both hands in a variety of functional contexts. The questionnaire includes 21 items, each rated on a 3-point scale: 0 (impossible), 1 (difficult), 2 (easy). The raw scores are converted to a linear Rasch scale, providing a standardized measure of manual ability. There is no fixed total score; instead, the Rasch analysis generates an overall ability estimate expressed in logits, allowing for comparison across individuals and groups. Higher scores represent the success in daily activities requiring the use of both hands.

    Measured: 5 minutes

  2. Pediatric Motor Activity Log (PMAL)

    The PMAL is a parent-reported assessment tool designed to measure the frequency and quality of motor activities performed by children with upper limb impairments, such as cerebral palsy. It focuses on how often and how well the child uses their affected arm in daily activities. It consists of 30 items, each rated on two scales: frequency and quality (both from 1 to 5). "Frequency" reflects how often the child uses their affected arm during specific activities, while "quality" reflects the child's ability to perform the activity. Scores for each item are summed to create a total score for both frequency and quality, with separate scores for each. Higher scores indicate better motor function, meaning the child uses their affected arm more frequently and with higher quality in daily activities. The total score is the sum of the frequency and quality scores, and higher

    Measured: 5 minutes

  3. The Assessment of Life-Habits (Life-H)

    The Life-H is a tool designed to evaluate the impact of a disability on an individual's ability to participate in daily life activities, covering various domains of life such as mobility, communication, social participation, and self-care. It is used across different age groups, including children and adults, with a variety of conditions, particularly those with physical or neurological impairments. Each item is scored on a scale from 0 to 9, where 0 indicates no difficulty, and 9 indicates complete difficulty or inability to perform the activity. The raw scores for each domain can then be converted to a standardized score ranging from 0 to 10. Higher scores indicate greater difficulty or more significant limitations in life habits. A higher total score reflects more challenges in daily life participation, while a lower score indicates better function and fewer limitations.

    Measured: 5 minutes

  4. European Child Environment Questionnaire (ECEQ)

    The ECEQ is a tool used to assess the impact of environmental factors on the participation and daily activities of children, particularly those with disabilities. It evaluates various environmental domains, including the home, school, and community, to determine how these settings either support or limit a child's ability to engage in everyday tasks. The ECEQ helps to identify barriers and areas where environmental modifications or supports may be needed to enhance the child's quality of life and participation.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start1 Jan 2022
  3. Primary completion1 May 2023
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06707831
Sponsor's protocol ID
teleassessmentforCP
Status last verified
Nov 2024
First submitted
25 Nov 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17370477

  • Delioglu K, Unes S, Tuncdemir M, Ozal C, Biyik KS, Uzumcugil A. Interrater reliability of face-to-face, tele- and video-based assessments with the modified Mallet classification in brachial plexus birth injuries. J Hand Surg Eur Vol. 2024 May;49(5):576-582. doi: 10.1177/17531934231196118. Epub 2023 Sep 8.

    PubMed 37684022

  • Gungor F, Ovacik U, Ertan Harputlu O, Yekdaneh AA, Kurt I, Erturk Uzunoglu G, Polat Ilguz B, Akuzum F, Akbaba YA. Tele-assessment of core performance and functional capacity: Reliability, validity, and feasibility in healthy individuals. J Telemed Telecare. 2024 Jul;30(6):1017-1025. doi: 10.1177/1357633X221117335. Epub 2022 Aug 2.

    PubMed 35916001

  • Cabrera-Martos I, Ortiz-Rubio A, Torres-Sanchez I, Lopez-Lopez L, Rodriguez-Torres J, Carmen Valenza M. Agreement Between Face-to-Face and Tele-assessment of Upper Limb Functioning in Patients with Parkinson Disease. PM R. 2019 Jun;11(6):590-596. doi: 10.1002/pmrj.12001. Epub 2019 Mar 6.

    PubMed 30840363

  • Tan JR, Coulson S, Keep M. Face-to-Face Versus Video Assessment of Facial Paralysis: Implications for Telemedicine. J Med Internet Res. 2019 Apr 12;21(4):e11109. doi: 10.2196/11109.

    PubMed 30977734

  • Richmond T, Peterson C, Cason J, Billings M, Terrell EA, Lee ACW, Towey M, Parmanto B, Saptono A, Cohn ER, Brennan D. American Telemedicine Association's Principles for Delivering Telerehabilitation Services. Int J Telerehabil. 2017 Nov 20;9(2):63-68. doi: 10.5195/ijt.2017.6232. eCollection 2017 Fall.

    PubMed 29238450

  • Biyik KS, Ozal C, Tuncdemir M, Unes S, Delioglu K, Gunel MK. The functional health status of children with cerebral palsy during the COVID-19 pandemic stay-at-home period: a parental perspective. Turk J Pediatr. 2021;63(2):223-236. doi: 10.24953/turkjped.2021.02.006.

    PubMed 33929112

  • Yang P, Liu P, Li D, Zhao D. Corona Virus Disease 2019, a growing threat to children? J Infect. 2020 Jun;80(6):671-693. doi: 10.1016/j.jinf.2020.02.024. Epub 2020 Mar 3.

    PubMed 32142929

  • Rosenbaum PL, Silva M, Camden C. Let's not go back to 'normal'! lessons from COVID-19 for professionals working in childhood disability. Disabil Rehabil. 2021 Apr;43(7):1022-1028. doi: 10.1080/09638288.2020.1862925. Epub 2020 Dec 23.

    PubMed 33355010

  • Unes S, Tuncdemir M, Ozal C, Delioglu K, Seyhan Biyik K, Kerem Gunel M. Tele-assessment of trunk control in children with cerebral palsy: Intra- and inter-rater reliability, and validity of the trunk control measurement scale. J Telemed Telecare. 2026 Apr;32(3):266-274. doi: 10.1177/1357633X251336009. Epub 2025 Apr 30.

    PubMed 40302488

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy (CP), run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trunk Control Measurement Scale (TCMS) (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06707831, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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