Cerebral PalsyNCT06810063
Feasibility and Reliability of the Melbourne Assessment-2 (MA-2) for Telehealth
An observational study of Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Ohio State University at 1 site in United States.
Trial summary
The goals of this study: 1. Determine if a play based test of arm and hand movements is valid and reliable when conducted through telehealth for children with hemiplegic cerebral palsy. 2. Measure differences in parent, provider and child engagement when an assessment is conducted in-person compared to via telehealth. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, ages 2-10 years old with hemiplegic Cerebral palsy
Who may be able to join
- ages 2-10 years old
- hemiplegic cerebral palsy
- able to attend an in-person visit in the research lab OR live within 60 miles of the research lab
- able to attend a telehealth session with personal device
Who cannot join
- child or caregiver does not speak English
- unable to attend one in person visit and one telehealth visit within 1 month
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
The goals of this study:
- Determine if a play based test of arm and hand movements is valid and reliable when conducted through telehealth for children with hemiplegic cerebral palsy.
- Measure differences in parent, provider and child engagement when an assessment is conducted in-person compared to via telehealth.
- Rate caregivers' overall impressions of procedures when an assessment is conducted in-person compared to telehealth.
Participants will attend two visits, one in person and one through telehealth. During each visit, the child will play with common toys. The sessions will be video recorded and scored using two standardized assessments, the Melbourne Assessment-2 (MA-2) and the Assisting Hand Assessment.
Read the detailed description
After a child has a stroke, noticeable and lifelong developmental concerns emerge. One side of the body is typically much weaker, often impacting the arm/hand more than the leg/foot, so we focus on the arm/hand. The weakness is like adults with stroke, but in children, stroke impairs play, reaching for/holding toys, communication gestures, and whole-body movement. Because of this, most children with pediatric stroke will receive physical and/or occupational therapy throughout childhood. Traditionally, rehabilitation occurs with the child, caregiver and therapist meeting in person at clinics, homes, or schools. However, telehealth rehabilitation, where the therapist and patient meet virtually through a computer or tablet, has emerged a sustainable and accessible alternative. Telehealth also has the potential to improve access to quality treatments, improve health outcomes and reduce healthcare costs. One problem with telehealth rehabilitation is that few assessments have been validated for use in telehealth. In adults with stroke, researchers have identified several assessments for that work well via telehealth. Similarly, in children with one specific brain disease, researchers found that the results of one commonly used gross motor test are similar when delivered via telehealth compared to in-person. Unfortunately, there is no studied arm/hand assessment for children with stroke. This makes it hard to measure if telehealth rehabilitation changes arm/hand function. This proposal will test two playful arm/hand assessments via telehealth. Investigators will test 35 children (2-10 years old) twice (once in-person and once via telehealth) with the same assessment and compare the results. Investigators will use two well-established assessments, the Melbourne Assessment-2 and the Assisting Hand Assessment. Both assessments will be recorded- via camera (in-person) and secure videoconferencing (telehealth). Those recordings will then be scored by a therapist trained in the Melbourne Assessment and Assisting Hand Assessment. Investigators will compare the results of both assessments to see if the scores match.
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- Assessment only, no intervention
- Keywords
- Assessment, Telehealth
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment only, no interventionOther
Participants in this study complete two visits to test the agreement of telehealth and in person assessments of arm and hand movement.
| Study group | Role | What they receive |
|---|---|---|
| In-person vs. telehealth assessment | Participants will be randomly assigned to in-person visit first or telehealth visit first. Both groups will complete both visits. Each visit requires about 20 minutes. Receives: Other: Assessment only, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melbourne Assessment-2
Upper Extremity assessment, range 0-100, higher score indicates better outcomes.
Measured: 1 month
Assisting Hand Assessment
Upper extremity assessment, range 0-100, higher score indicates better outcomes.
Measured: 1 month
Secondary outcomes (3)
Acceptability Intervention Measure
Evaluate acceptability of telehealth assessment, 4 questions rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Reported as proportion of items rated at or above 4/5
Measured: immediately after telehealth visit
Intervention Appropriateness Measure
Evaluate appropriateness of telehealth assessment, 4 questions rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Reported as proportion of items rated at or above 4/5
Measured: immediately after telehealth visit
Feasibility of Intervention Measure
Evaluate feasibility of telehealth assessment, 4 questions rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Reported as proportion of items rated at or above 4/5
Measured: immediately after telehealth visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start18 Sep 2023
- Primary completion24 Nov 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Heathcock, Ohio State University
- Investigators
- Jill Heathcock, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810063
- Sponsor's protocol ID
- 2023B0100
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of the Melbourne Assessment-2 (MA-2) for Telehealth
- ClinicalTrials.gov ID
- NCT06810063
- Acronym / sponsor ID
- 2023B0100
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- Assessment, Telehealth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this study:
- Determine if a play based test of arm and hand movements is valid and reliable when conducted through telehealth for children with hemiplegic cerebral palsy.
- Measure differences in parent, provider and child engagement when an assessment is conducted in-person compared to via telehealth.
- Rate caregivers' overall impressions of procedures when an assessment is conducted in-person compared to telehealth.
Participants will attend two visits, one in person and one through telehealth. During each visit, the child will play with common toys. The sessions will be video recorded and scored using two standardized assessments, the Melbourne Assessment-2 (MA-2) and the Assisting Hand Assessment.
Detailed description
After a child has a stroke, noticeable and lifelong developmental concerns emerge. One side of the body is typically much weaker, often impacting the arm/hand more than the leg/foot, so we focus on the arm/hand. The weakness is like adults with stroke, but in children, stroke impairs play, reaching for/holding toys, communication gestures, and whole-body movement. Because of this, most children with pediatric stroke will receive physical and/or occupational therapy throughout childhood. Traditionally, rehabilitation occurs with the child, caregiver and therapist meeting in person at clinics, homes, or schools. However, telehealth rehabilitation, where the therapist and patient meet virtually through a computer or tablet, has emerged a sustainable and accessible alternative. Telehealth also has the potential to improve access to quality treatments, improve health outcomes and reduce healthcare costs. One problem with telehealth rehabilitation is that few assessments have been validated for use in telehealth. In adults with stroke, researchers have identified several assessments for that work well via telehealth. Similarly, in children with one specific brain disease, researchers found that the results of one commonly used gross motor test are similar when delivered via telehealth compared to in-person. Unfortunately, there is no studied arm/hand assessment for children with stroke. This makes it hard to measure if telehealth rehabilitation changes arm/hand function. This proposal will test two playful arm/hand assessments via telehealth. Investigators will test 35 children (2-10 years old) twice (once in-person and once via telehealth) with the same assessment and compare the results. Investigators will use two well-established assessments, the Melbourne Assessment-2 and the Assisting Hand Assessment. Both assessments will be recorded- via camera (in-person) and secure videoconferencing (telehealth). Those recordings will then be scored by a therapist trained in the Melbourne Assessment and Assisting Hand Assessment. Investigators will compare the results of both assessments to see if the scores match.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-person vs. telehealth assessment | – | Other: Assessment only, no interventionParticipants will be randomly assigned to in-person visit first or telehealth visit first. Both groups will complete both visits. Each visit requires about 20 minutes. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, ages 2-10 years old with hemiplegic Cerebral palsy
Key inclusion criteria (4 listed)
- ages 2-10 years old
- hemiplegic cerebral palsy
- able to attend an in-person visit in the research lab OR live within 60 miles of the research lab
- able to attend a telehealth session with personal device
Key exclusion criteria (2 listed)
- child or caregiver does not speak English
- unable to attend one in person visit and one telehealth visit within 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment only, no interventionParticipants in this study complete two visits to test the agreement of telehealth and in person assessments of arm and hand movement. | Other | In-person vs. telehealth assessment |
Primary outcome
Melbourne Assessment-2
Time frame: 1 month
Upper Extremity assessment, range 0-100, higher score indicates better outcomes.
Assisting Hand Assessment
Time frame: 1 month
Upper extremity assessment, range 0-100, higher score indicates better outcomes.
3 secondary outcomes
Acceptability Intervention Measure
Time frame: immediately after telehealth visit
Intervention Appropriateness Measure
Time frame: immediately after telehealth visit
Feasibility of Intervention Measure
Time frame: immediately after telehealth visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Heathcock, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Ohio State University at 1 site in United States.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Melbourne Assessment-2 (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.