Hybrid Telehealth in Pediatric Physical Therapy

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05350904

Collaborator

(none)

Enrollment

19.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Disorder Disability, Developmental	Other: Hybrid of telehealth and in-person physical therapy services	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Change in Canadian Occupational Performance Measure [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
Measures of Processes of Care (MPOC) [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
Change in Pediatric Evaluation of Disability Inventory [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
Semi-structured interviews with caregivers and children in experimental group [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jamie Hall, Assistant Teaching Professor, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT05350904

Other Study ID Numbers:

2090371

First Posted:

Apr 28, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Developmental Disabilities

Study Results

No Results Posted as of Apr 28, 2022