NCT06810063

Brief Summary

The goals of this study:

  1. 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. 2.Measure differences in parent, provider and child engagement when an assessment is conducted in-person compared to via telehealth.
  3. 3.Rate caregivers' overall impressions of procedures when an assessment is conducted in-person compared to telehealth.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

January 24, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

AssessmentTelehealth

Outcome Measures

Primary Outcomes (2)

  • Melbourne Assessment-2

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

    1 month

  • Assisting Hand Assessment

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

    1 month

Secondary Outcomes (3)

  • Acceptability Intervention Measure

    immediately after telehealth visit

  • Intervention Appropriateness Measure

    immediately after telehealth visit

  • Feasibility of Intervention Measure

    immediately after telehealth visit

Study Arms (1)

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.

Other: Assessment only, no intervention

Interventions

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

In-person vs. telehealth assessment

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children, ages 2-10 years old with hemiplegic Cerebral palsy

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jill Heathcock, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Division of Physical Therapy

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 5, 2025

Study Start

September 18, 2023

Primary Completion

November 24, 2025

Study Completion

May 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations