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临床试验/NCT06810063
NCT06810063进行中(未招募)不适用

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

Ohio State University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
35
试验地点
1
主要终点
Melbourne Assessment-2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Melbourne Assessment-2

时间窗: 1 month

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

Assisting Hand Assessment

时间窗: 1 month

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

次要结局

  • Acceptability Intervention Measure(immediately after telehealth visit)
  • Intervention Appropriateness Measure(immediately after telehealth visit)
  • Feasibility of Intervention Measure(immediately after telehealth visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Heathcock

Professor, Division of Physical Therapy

Ohio State University

研究点 (1)

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