- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383753
Virtual Hand-Arm Assessments for Children With Cerebral Palsy
Virtual Hand-Arm Assessments for Children With Cerebral Palsy: Helping Us to Achieve Equity in Rehabilitation Care and Research
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral Palsy (CP) impacts 1 in 500 Canadian children and most (60-83%) have hand/arm limitations that adversely affect independence in daily activities, school, leisure, and social participation. Optimizing hand/arm abilities via therapeutic, surgical and pharmaceutical interventions is a key focus of CP management for children, parents, and clinicians and can involve many clinic appointments for assessments, therapeutic interventions, and follow-up. At best, this introduces a significant family burden with children missing school and potentially other extra-curricular activities and parents juggling work, scheduling and costs. At worst, it means that many children with CP do not receive rehabilitation services and are systemically underrepresented in clinical research studies that could positively impact their lives. Barriers to in-person care include geographic considerations, time/scheduling, availability, socioeconomic factors, not to mention COVID-19-related interruptions. One potential solution to promote equitable and family-focused access to care is to grow capacity for virtual care that can be managed remotely (e.g. via phone/video).
There is a growing movement "not to return to normal" post-COVID, but rather to use the technological advances and learnings to "expand the range, nature and locations of our services for children with developmental disabilities and their families." Many organizations, including our knowledge partner Holland Bloorview Kids Rehabilitation Hospital (HB), have committed to continuing and expanding virtual care options in response to positive family feedback that supports hybrid (virtual/in-person) models of care. This research priority is shared by the wider community of pediatric rehabilitation. Importantly, the goal is not to displace in-person care; rather it is to understand when virtual options can and cannot be offered. It is essential that virtual care, like in-person care, be evidence-based and aligned with current best research findings, clinical expertise and patient/client preferences.
While novel ways of delivering hand-arm therapy via videoconferencing and caregiver engagement have been innovated, it is still difficult to assess hand-arm skills virtually. Hand-arm rehabilitation must be guided by reliable assessment via a combination of patient-reported outcome measures (PROMs), direct measurement, and therapist observations to capture the function, activity, and participation domains of the World Health Organization's International Classification of Function, Disability, and Health (WHO ICF). Outside of PROMs, there are no validated tools for virtual hand-arm assessment of children with CP. This project will focus on direct- and therapist-observed tools to complement digitally-based PROMs that are already suitable for use in virtual assessment. It will address critical issues in need of systematic research as identified in the literature, specifically: What hand-arm assessments can be done virtually? And, what do families want and need in virtual assessments? This study aims to validate well-established standardized measures for virtual administration to support current research and clinical practice, while also exploring individualized measures that can capture the child engaging in their own environment. The ability to observe children in their natural context is seen as an added advantage of virtual assessment.
This critical and timely work is needed to ensure continuation/expansion of the positive practice changes made to overcome access-to-care barriers. Promoting equity, diversity and inclusion in the healthcare system is an urgent priority of health agencies across Canada. Advancing virtual assessment is a complementary and foundational step towards research and practice of evidence-based virtual interventions. This research will quickly generate evidence on the use of existing tools for virtual assessment and what is achievable in the home context. It will contribute new learnings on assessments that can capture the child more naturally in their own environment. This study will identify areas where virtual assessment may not be advisable with currently available tools and provide family-directed learnings for future work.
This study will adopt a convergent mixed methods design including a test-retest approach to compare the feasibility, acceptability, and equivalence of virtual and in-person hand/arm assessments. 100 children and their caregivers will complete the 1 - 1.5 hour assessment protocol twice, once in clinic and once virtually at home via Zoom video-conferencing. A therapist will oversee both assessments. The virtual assessment will occur first. One week later, families will do a second virtual assessment with the same therapist to establish test-retest reliability and to capture any changes in their experience of or perspectives on virtual assessments. The virtual assessment will occur 1 - 3 days after the re-test. Feasibility, acceptability, and equivalence of in-person and virtual assessment will be investigated through quantitative and qualitative methods. For the latter, this study will purposefully recruit (i.e. with diversity as a focus) 25 parents and 25 children for follow-up interviews. All 6 research therapists will also be interviewed after their final session on the risks, opportunities and challenges of virtual assessment.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gloria Lee, MSc
- Phone Number: 3342 416-425-6220
- Email: glee@hollandbloorview.ca
Study Contact Backup
- Name: Selvi Sert, MEng
- Phone Number: 3109 416-425-6220
- Email: ssert@hollandbloorview.ca
Study Locations
-
-
Ontario
-
Ajax, Ontario, Canada, L1T 0R3
- Recruiting
- Grandview Kids
-
Contact:
- Shantel Mangroo
- Phone Number: 437-703-9184
- Email: shantel.mangroo@grandviewkids.ca
-
Principal Investigator:
- Shannon Knights, MD
-
Ottawa, Ontario, Canada, K1H 8L1
- Recruiting
- Children's Hospital of Eastern Ontario
-
Principal Investigator:
- Anna McCormick, MD
-
Contact:
- Research Assistant
- Phone Number: 6281 613-737-7600
- Email: ANizam@cheo.on.ca
-
Contact:
- Research Coordinator
- Phone Number: 4359 613-737-7600
- Email: MLarin@cheo.on.ca
-
Toronto, Ontario, Canada, M4G 1R8
- Recruiting
- Holland Bloorview Kids Rehabilitation Hospital
-
Principal Investigator:
- Elaine Biddiss, PhD
-
Contact:
- Research Coordinator
- Phone Number: 3109 416-425-6220
- Email: ssert@hollandbloorview.ca
-
Contact:
- Research Manager
- Phone Number: 3342 416-425-6220
- Email: glee@hollandbloorview.ca
-
Principal Investigator:
- Virginia Wright, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- Has a caregiver willing to participate and can questions about preferences
- Have an appropriate device and internet access for video conferencing
Exclusion Criteria:
- Active treatments (e.g. Botulinum Toxin injections or constraint therapy in the last two months, or upper extremity surgery in the last 6 months) that might impact upper limb function stability over the study period.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with Cerebral Palsy (CP)
children and adolescents aged 6 to 17 years with a confirmed diagnosis of cerebral palsy and functional hand-arm abilities classified within MACS Levels I-III.
All participants must have the cognitive and physical capacity to participate in virtual assessments lasting up to 30 minutes at a time, access to a device and internet connection suitable for videoconferencing, and a caregiver willing to participate in study procedures and provide input on preferences and experiences.
Participants complete a standardized series of virtual and in-person upper-limb assessments, wear wrist-worn inertial sensors at home for five days, and contribute caregiver- and child-reported feedback on feasibility, acceptability, and preferences.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Virtual Upper-Limb Assessments: Completion Rate of Virtual aROM
Time Frame: From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).
|
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.
|
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)
Time Frame: From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).
|
The percentage of enrolled participants who complete the virtually administered Box and Block Test (BBT).
Feasibility success is defined a priori as >70% completion.
|
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)
Time Frame: From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).
|
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.
|
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)
Time Frame: From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).
|
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.
|
From enrollment through completion of the 2 virtual assessments (approximately 2 weeks).
|
|
Feasibility of Virtual Upper-Limb Assessments: Recruitment and Attrition Metrics
Time Frame: From enrollment through completion of participation (approximately 3-4 weeks).
|
Recruitment rate (number of participants enrolled over the recruitment period), attrition rate (percentage of enrolled participants who do not complete the virtual assessment component), and documented reasons for non-eligibility, non-participation, or withdrawal.
|
From enrollment through completion of participation (approximately 3-4 weeks).
|
|
Feasibility of Virtual Upper-Limb Assessments: Ability to Obtain Required Household Materials for Virtual Assessment
Time Frame: Prior to commencement of virtual assessments (Week 1)
|
The percentage of families who report successfully obtaining all required household materials needed to complete the virtual standardized assessments from home.
|
Prior to commencement of virtual assessments (Week 1)
|
|
Feasibility of Virtual Upper-Limb Assessments: Technical, Environmental, Behavioral, and Cognitive Challenges During Virtual Sessions
Time Frame: During Virtual Assessment 1 and Virtual Assessment 2 (approximately 2 weeks)
|
The number of technical (e.g., dropped connection), video quality (e.g., lighting, camera angle), behavioral (e.g., distraction), and cognitive (e.g., confusion) challenges observed during virtual assessment sessions, coded from session videos using the standardized Observational Checklist and Behavioural Observation Research Interactive Software (BORIS).
|
During Virtual Assessment 1 and Virtual Assessment 2 (approximately 2 weeks)
|
|
Feasibility of Virtual Upper-Limb Assessments: Duration of Virtual and In-Person aROM
Time Frame: During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
Time required to complete the active range of motion (aROM) when administered virtually compared to in person, as recorded using the standardized Observational Checklist.
|
During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
|
Feasibility of Virtual Upper-Limb Assessments: Duration of Virtual and In-Person BBT
Time Frame: During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
Time required to complete the Box and Blocks Test (BBT) when administered virtually compared to in person, as recorded using the standardized Observational Checklist.
|
During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
|
Feasibility of Virtual Upper-Limb Assessments: Duration of Virtual and In-Person QUEST
Time Frame: During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
Time required to complete the QUEST when administered virtually compared to in person, as recorded using the standardized Observational Checklist.
|
During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
|
Feasibility of Virtual Upper-Limb Assessments: Duration of Virtual and In-Person SHUEE-SFA
Time Frame: During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
Time required to complete the SHUEE-SFA when administered virtually compared to in person, as recorded using the standardized Observational Checklist.
|
During Virtual Assessment #1, Virtual Assessment #2 and In-Person Assessment Session #1 (approximately 3 weeks)
|
|
Acceptability of Virtual aROM (Caregiver and Therapist)
Time Frame: Immediately after each virtual and in-person assessment (weeks 1-3).
|
Acceptability of virtual administration of the active range of motion (aROM) assessment will be measured using a post-session Acceptability Survey administered via REDCap.
After each assessment session, caregivers and the occupational therapist will each rate whether the virtual administration of the aROM was comparable or preferable to in-person administration.
Acceptability success is defined a priori as >70% comparable or preferable ratings.
|
Immediately after each virtual and in-person assessment (weeks 1-3).
|
|
Acceptability of Virtual Box and Block Test (Caregiver and Therapist)
Time Frame: Immediately after each virtual and in-person assessment (weeks 1-3).
|
Acceptability of virtual administration of the Box and Block Test will be measured using a post-session Acceptability Survey administered via REDCap.
After each assessment session, caregivers and the occupational therapist will each rate whether the virtual administration of the BBT was comparable or preferable to in-person administration.
Acceptability success is defined a priori as >70% comparable or preferable ratings.
|
Immediately after each virtual and in-person assessment (weeks 1-3).
|
|
Acceptability of Virtual QUEST (Caregiver and Therapist)
Time Frame: Immediately after each virtual and in-person assessment (weeks 1-3).
|
Acceptability of virtual administration of the QUEST will be measured using a post-session Acceptability Survey administered via REDCap.
After each assessment session, caregivers and the occupational therapist will each rate whether the virtual administration of the QUEST was comparable or preferable to in-person administration.
Acceptability success is defined a priori as >70% comparable or preferable ratings.
|
Immediately after each virtual and in-person assessment (weeks 1-3).
|
|
Acceptability of Virtual SHUEE-SFA (Caregiver and Therapist)
Time Frame: Immediately after each virtual and in-person assessment (weeks 1-3).
|
Acceptability of virtual administration of the SHUEE-SFA will be measured using a post-session Acceptability Survey administered via REDCap.
After each assessment session, caregivers and the occupational therapist will each rate whether the virtual administration of the SHUEE-SFA was comparable or preferable to in-person administration.
Acceptability success is defined a priori as >70% comparable or preferable ratings.
|
Immediately after each virtual and in-person assessment (weeks 1-3).
|
|
Equivalence of Virtual and In-Person aROM Scores
Time Frame: Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
Agreement between virtual and in-person assessment aROM scores (scored live, 2-3 days apart) will be examined using mean absolute differences, intraclass correlation coefficients (ICCs; target ICC ≥0.90, lower 95% CI >0.60), Bland-Altman limits of agreement, and coefficient of variation (<10%).
Equivalence is met if 80% confidence limits fall within each test's minimally important change or smallest detectable difference.
Factors contributing to low agreement (e.g., internet quality, scope of view) will be explored using session videos.
|
Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
|
Equivalence of Virtual and In-Person BBT Scores
Time Frame: Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
Agreement between virtual and in-person assessment BBT scores (scored live, 2-3 days apart) will be examined using mean absolute differences, intraclass correlation coefficients (ICCs; target ICC ≥0.90, lower 95% CI >0.60), Bland-Altman limits of agreement, and coefficient of variation (<10%).
Equivalence is met if 80% confidence limits fall within each test's minimally important change or smallest detectable difference.
Factors contributing to low agreement (e.g., internet quality, scope of view) will be explored using session videos.
|
Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
|
Equivalence of Virtual and In-Person QUEST Scores
Time Frame: Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
Agreement between virtual and in-person assessment QUEST scores (scored live, 2-3 days apart) will be examined using mean absolute differences, intraclass correlation coefficients (ICCs; target ICC ≥0.90, lower 95% CI >0.60), Bland-Altman limits of agreement, and coefficient of variation (<10%).
Equivalence is met if 80% confidence limits fall within each test's minimally important change or smallest detectable difference.
Factors contributing to low agreement (e.g., internet quality, scope of view) will be explored using session videos.
|
Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
|
Equivalence of Virtual and In-Person SHUEE-SFA Scores
Time Frame: Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
Agreement between virtual and in-person assessment SHUEE-SFA scores (scored live, 2-3 days apart) will be examined using mean absolute differences, intraclass correlation coefficients (ICCs; target ICC ≥0.90, lower 95% CI >0.60), Bland-Altman limits of agreement, and coefficient of variation (<10%).
Equivalence is met if 80% confidence limits fall within each test's minimally important change or smallest detectable difference.
Factors contributing to low agreement (e.g., internet quality, scope of view) will be explored using session videos.
|
Across the two virtual assessments and subsequent in-person assessment (approximately 3 weeks).
|
|
Test-Retest Reliability of Virtual aROM
Time Frame: Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
Reliability will be evaluated using ICCs for (a) the two virtual assessments performed one week apart (live scoring), and (b) live scoring versus video-based scoring.
Paired t-tests will examine systematic differences across repeated sessions.
|
Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
|
Test-Retest Reliability of Virtual BBT
Time Frame: Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
Reliability will be evaluated using ICCs for (a) the two virtual assessments performed one week apart (live scoring), and (b) live scoring versus video-based scoring.
Paired t-tests will examine systematic differences across repeated sessions.
|
Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
|
Test-Retest Reliability of Virtual QUEST
Time Frame: Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
Reliability will be evaluated using ICCs for (a) the two virtual assessments performed one week apart (live scoring), and (b) live scoring versus video-based scoring.
Paired t-tests will examine systematic differences across repeated sessions.
|
Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
|
Test-Retest Reliability of Virtual SHUEE-SFA
Time Frame: Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
Reliability will be evaluated using ICCs for (a) the two virtual assessments performed one week apart (live scoring), and (b) live scoring versus video-based scoring.
Paired t-tests will examine systematic differences across repeated sessions.
|
Between Virtual Assessment 1 and Virtual Assessment 2 (1-week interval).
|
|
Predictors of Feasibility, Acceptability, and Equivalence
Time Frame: From enrollment through completion of participation (approximately 3-4 weeks).
|
Logistic regression analyses will examine whether participant characteristics (age, disability level [MACS], gender, sex, ethnicity, socioeconomic status) predict three dichotomized outcomes: (1) completion of virtual standardized assessments (yes/no), (2) willingness to participate in future virtual assessments (yes/no), and (3) acceptable agreement between virtual and in-person assessment scores (yes/no).
|
From enrollment through completion of participation (approximately 3-4 weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Caregiver-Recorded Activity Videos (PQRS)
Time Frame: During weeks 1-3.
|
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.
|
During weeks 1-3.
|
|
Acceptability of Caregiver-Recorded Videos
Time Frame: Immediately after video submission (weeks 1-3).
|
Percentage of families reporting satisfaction with video recording as a component of assessment, using an a priori threshold of >70% satisfaction.
|
Immediately after video submission (weeks 1-3).
|
|
Test-Retest Reliability of Perceived Quality Rating Scale (PQRS) Scores
Time Frame: Across two video-recording periods separated by approximately 1 week
|
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).
|
Across two video-recording periods separated by approximately 1 week
|
|
Feasibility of Gamified Assessment Tasks
Time Frame: During the in-person assessment (week 3).
|
Percentage of participants who successfully complete all gamified tasks.
|
During the in-person assessment (week 3).
|
|
Acceptability of Gamified Assessment Tasks
Time Frame: In-person assessment (Week 3).
|
Measured by the caregiver using a post-session Acceptability Survey administered via REDCap following the in-person assessment session.
|
In-person assessment (Week 3).
|
|
Convergent Validity of Gamified Movement Metrics
Time Frame: During in-person assessment (week 3).
|
Correlations will be computed between kinematic outputs (e.g., smoothness, peak velocity, reach envelope, symmetry) and established clinical assessments (e.g., aROM, AHA symmetry scores).
|
During in-person assessment (week 3).
|
|
Feasibility of Wrist-Worn Inertial Sensors
Time Frame: 5-day home monitoring period (week 2).
|
Percentage of participants who successfully collect >15 hours of usable sensor data over 5 days, and the proportion who wear sensors during in-person assessment when appropriate.
|
5-day home monitoring period (week 2).
|
|
Acceptability of Inertial Sensors
Time Frame: Immediately after sensor-wear period (week 2).
|
Measured as the percentage of children who report willingness to wear the sensors again following completion of the sensor wear period.
|
Immediately after sensor-wear period (week 2).
|
|
Convergent Validity of Inertial Sensor Activity Counts
Time Frame: During the 5-day sensor-wear period and in-person assessment session (weeks 2-3).
|
Assessed using correlation analyses between SHUEE Spontaneous Functional Analysis (SHUEE-SFA) scores and acceleration-derived activity counts and activity-count ratios for the dominant and hemiplegic limb.
Activity counts will be derived using (i) an established threshold-based method and (ii) a machine-learning-based classifier, with activity counts from the best-performing classifier used in the correlation analysis.
|
During the 5-day sensor-wear period and in-person assessment session (weeks 2-3).
|
|
Performance of Machine-Learning Classifier for Functional Arm Use
Time Frame: During data analysis following completion of inertial sensor data collection
|
Performance of the machine-learning classifier used to classify functional and non-functional arm movements will be evaluated using precision, recall, and F1-score, based on Leave-One-Subject-Out cross-validation.
|
During data analysis following completion of inertial sensor data collection
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Themes on Experiences With Virtual and In-Person Assessment
Time Frame: Week 4
|
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.
|
Week 4
|
|
Integrated Mixed-Methods Findings on Feasibility, Acceptability, Equivalence and and Family/Clinician Experience
Time Frame: After completion of all quantitative and qualitative analyses (approximately weeks 4-6 following the final participant visit)
|
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.
|
After completion of all quantitative and qualitative analyses (approximately weeks 4-6 following the final participant visit)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elaine Biddiss, PhD, Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute
- Principal Investigator: Virginia Wright, PhD, Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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