NCT05350904

Brief Summary

The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. This is a mixed methods study.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 5, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 19, 2026

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

April 5, 2022

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Canadian Occupational Performance Measure

    evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living

    after physical therapy episode of care an average of 12 weeks

  • Measures of Processes of Care (MPOC)

    Survey tool which assesses parents' perceptions of the care they and their children receive from children's rehabilitation treatment centers. Designed to assess the family-centered behaviours of healthcare providers

    after physical therapy episode of care, an average of 12 weeks

  • Change in Pediatric Evaluation of Disability Inventory

    Assess key functional capabilities and performance in children whose functional abilities are lower than those of seven-year-olds without disabilities

    after physical therapy episode of care, an average of 12 weeks

  • Semi-structured interviews with caregivers and children in experimental group

    Will follow an interview guide designed to capture the experiences of caregivers and children with telehealth

    after physical therapy episode of care, an average of 12 weeks

Interventions

The experimental group will receive a hybrid of telehealth and in-person physical therapy services to address an in-home functional skill in children with moderate to severe disability.

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 2-17 years old with moderate to significant disability.
  • Families have access to minimum technology necessary to participate in a telehealth visit. ---The child's insurance covers telehealth visits.

You may not qualify if:

  • Caregiver does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The control group will receive usual physical therapy care. The experimental group will receive a hybrid of in-person and telehealth services to address in-home functional skills.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Teaching Professor

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 28, 2022

Study Start

May 15, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 19, 2026

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations