Virtual Hand-Arm Assessments for Children With Cerebral Palsy

ConditionCerebral Palsy (CP)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6-17

SponsorHolland Bloorview Kids Rehabilitation Hospital

About this trial

Cerebral palsy (CP) affects approximately 1 in 500 Canadian children, and the majority experience hand and arm limitations that impact independence, participation in daily activities, and overall quality of life. Many children require ongoing clinical assessments and therapy delivered in specialized centres, creating significant burden related to travel, scheduling, and interruptions to school and work. Barriers such as geography, socioeconomic factors, and pandemic-related service disruptions have further limited equitable access to in-person care. Although virtual care has expanded rapidly and families have expressed strong interest in hybrid care models, there is currently no validated approach for conducting comprehensive virtual hand-arm assessments for children with CP. Virtual administration of standardized assessments, individualized goal-based evaluations, and naturalistic observation tools has not been systematically studied. Evidence is urgently needed to determine which assessments can be administered virtually, how acceptable and feasible they are for families, and whether virtual and in-person assessment methods produce equivalent results.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis of Cerebral Palsy

Are between 6 to 17 years old with sufficient cognitive capacity and cooperation to sit without a break for 30 minutes at a time

MACS levels I (handles objects easily) to III (handles objects with difficulty)

No visual limitations that would interfere with video conferencing

Disqualifiers

None

Trial population

The study population consists of children and adolescents aged 6 to 17 years with a confirmed diagnosis of cerebral palsy who have functional hand and arm abilities classified within Manual Ability Classification System (MACS) Levels I-III. Participants must have sufficient cognitive and physical capacity to participate in virtual videoconference-based assessments for up to 30 minutes at a time and must have access to an internet-enabled device suitable for completing virtual sessions. Each participant must be accompanied by a caregiver who can assist with study procedures, provide demographic and experience-related information, and record brief home activity videos.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Upper-Limb Virtual and In-Person Assessment
Other intervention
Participants complete a standardized upper-limb assessment protocol that includes two virtual videoconference assessments-delivered one week apart to evaluate test-retest reliability-and one in-person clinic assessment with the same research therapist to enable within-participant comparison of virtual and in-person scores. After each session, children, caregivers, and therapists complete brief surveys assessing feasibility, ease of completion, acceptability, and preferences. Participants also wear bilateral wrist-worn inertial sensors for five consecutive days at home to collect continuous data on naturalistic upper-limb activity. Families also provide caregiver-recorded videos of the child performing two preselected meaningful activities in their home environment. These videos are later scored using the Perceived Quality Rating Scale (PQRS) to evaluate individualized functional performance.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Children with Cerebral Palsy (CP)1 intervention

Trial outcomes

Primary outcomes

Feasibility of Virtual Upper-Limb Assessments: Completion Rate of Virtual aROM

The percentage of enrolled participants who complete the virtually administered active range of motion (aROM) assessment. Feasibility success is defined a priori as \>70% completion.

Time frame

From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).

Feasibility of Virtual Upper-Limb Assessments: Completion Rate of Virtual Box and Block Test (BBT)

The percentage of enrolled participants who complete the virtually administered Box and Block Test (BBT). Feasibility success is defined a priori as \>70% completion.

Time frame

From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).

Feasibility of Virtual Upper-Limb Assessments: Completion Rate of Virtual Quality of Upper Extremity Skills Test (QUEST)

The percentage of enrolled participants who complete the virtually administered Quality of Upper Extremity Skills Test (QUEST). Feasibility success is defined a priori as \>70% completion.

Time frame

From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).

Feasibility of Virtual Upper-Limb Assessments: Completion Rate of Virtual SHUEE Spontaneous Functional Analysis (SHUEE-SFA)

The percentage of enrolled participants who complete the virtually administered SHUEE Spontaneous Functional Analysis (SHUEE-SFA). Feasibility success is defined a priori as \>70% completion.

Time frame

From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).

Secondary outcomes

Feasibility of Caregiver-Recorded Activity Videos (PQRS)

Proportion of families who successfully produce two scorable activity videos following (a) in-person therapist instruction and (b) virtual therapist instruction. Success defined as \>70% scorable videos.

Time frame

During weeks 1-3.

Acceptability of Caregiver-Recorded Videos

Percentage of families reporting satisfaction with video recording as a component of assessment, using an a priori threshold of \>70% satisfaction.

Time frame

Immediately after video submission (weeks 1-3).

Test-Retest Reliability of Perceived Quality Rating Scale (PQRS) Scores

Test-retest reliability of caregiver-recorded activity videos will be evaluated using intraclass correlation coefficients (ICCs), a unitless reliability statistic, calculated across two sets of videos recorded approximately one week apart for the same individualized activities and scored using the Perceived Quality Rating Scale (PQRS).

Time frame

Across two video-recording periods separated by approximately 1 week

Feasibility of Gamified Assessment Tasks

Percentage of participants who successfully complete all gamified tasks.

Time frame

During the in-person assessment (week 3).

Other outcomes

Qualitative Themes on Experiences With Virtual and In-Person Assessment

Semi-structured interviews with children, caregivers, and therapists will be analyzed using reflexive thematic analysis. Outcomes include themes and subthemes describing perceptions of feasibility, acceptability, barriers, facilitators, and recommendations for implementation.

Time frame

Week 4

Integrated Mixed-Methods Findings on Feasibility, Acceptability, Equivalence and and Family/Clinician Experience

Quantitative and qualitative data will be merged following their initial analyses to examine complementarity, convergence, and divergence, as well as family and clinician experiences with virtual and in-person assessments. Integration will use a weaving approach, with qualitative and quantitative findings presented together by theme and summarized narratively and through joint displays. Side-by-side joint displays will compare quantitative indicators (e.g., demographics, number of technical issues) with qualitative data (e.g., interview quotes) to contextualize preferences and experiences related to virtual and in-person assessment. Joint displays will organize qualitative themes by Theoretical Domains Framework (TDF) domains to support interpretation of clinician and family experiences.

Time frame

After completion of all quantitative and qualitative analyses (approximately weeks 4-6 following the final participant visit)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Holland Bloorview Kids Rehabilitation Hospital

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

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