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OpenTrials
Active, Not Recruiting

NCT Number: NCT06810063

Feasibility and Reliability of the Melbourne Assessment-2 (MA-2) for Telehealth

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. 3. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • child or caregiver does not speak English
  • unable to attend one in person visit and one telehealth visit within 1 month

Treatment and study plan

Assessment only, no intervention

Other

Participants in this study complete two visits to test the agreement of telehealth and in person assessments of arm and hand movement.

Primary outcomes

  1. Melbourne Assessment-2

    Time frame: 1 month

    Upper Extremity assessment, range 0-100, higher score indicates better outcomes.

  2. Assisting Hand Assessment

    Time frame: 1 month

    Upper extremity assessment, range 0-100, higher score indicates better outcomes.

Secondary outcomes

  1. Acceptability Intervention Measure

    Time frame: immediately after telehealth visit

    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

  2. Intervention Appropriateness Measure

    Time frame: immediately after telehealth visit

    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

  3. Feasibility of Intervention Measure

    Time frame: immediately after telehealth visit

    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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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