- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350904
Hybrid Telehealth in Pediatric Physical Therapy
Does Hybrid Telehealth Physical Therapy for Children With Moderate to Severe Disability Improve Function in the Home Environment Better Than In-person Services Alone?--A Mixed Methods Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Research questions include:
Is a hybrid of telehealth and in-person physical therapy service better than in-person services alone for improving in-home functional skills in children with moderate to severe disability?
Is there a difference in the satisfaction of caregivers and children with physical therapy services which consist of a hybrid of telehealth and in-person physical therapy services compared to in-person services alone?
What is the experience of children and caregivers who receive a hybrid of telehealth and in-person physical therapy services during an episode of care?
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-Caregiver does not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Canadian Occupational Performance Measure
Time Frame: after physical therapy episode of care an average of 12 weeks
|
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)
Time Frame: after physical therapy episode of care, an average of 12 weeks
|
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
Time Frame: after physical therapy episode of care, an average of 12 weeks
|
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
Time Frame: after physical therapy episode of care, an average of 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2090371
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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