Clinical trial NCT06810063: Feasibility and Reliability of the Melbourne Assessment-2 (MA-2) for Telehealth
Official title: Feasibility and Reliability of the Melbourne Assessment-2 (MA-2) for Telehealth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Hemiplegic Cerebral Palsy
Keywords: Assessment
Telehealth
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, ages 2-10 years old with hemiplegic Cerebral palsy

Brief 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.
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Melbourne Assessment-2
timeFrame: 1 month
measure: Assisting Hand Assessment
timeFrame: 1 month
Secondary outcomes:
measure: Acceptability Intervention Measure
timeFrame: immediately after telehealth visit
measure: Intervention Appropriateness Measure
timeFrame: immediately after telehealth visit
measure: Feasibility of Intervention Measure
timeFrame: immediately after telehealth visit
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jill Heathcock, PhD
role: PRINCIPAL_INVESTIGATOR
References: