Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT05350904
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2022-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid Telehealth in Pediatric Physical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Canadian Occupational Performance Measure', 'timeFrame': 'after physical therapy episode of care an average of 12 weeks', 'description': "evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living"}, {'measure': 'Measures of Processes of Care (MPOC)', 'timeFrame': 'after physical therapy episode of care, an average of 12 weeks', 'description': "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"}, {'measure': 'Change in Pediatric Evaluation of Disability Inventory', 'timeFrame': 'after physical therapy episode of care, an average of 12 weeks', 'description': 'Assess key functional capabilities and performance in children whose functional abilities are lower than those of seven-year-olds without disabilities'}, {'measure': 'Semi-structured interviews with caregivers and children in experimental group', 'timeFrame': 'after physical therapy episode of care, an average of 12 weeks', 'description': 'Will follow an interview guide designed to capture the experiences of caregivers and children with telehealth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Disorder', 'Disability, Developmental']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\nIs 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?\n\nIs 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?\n\nWhat is the experience of children and caregivers who receive a hybrid of telehealth and in-person physical therapy services during an episode of care?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children 2-17 years old with moderate to significant disability.\n* Families have access to minimum technology necessary to participate in a telehealth visit. ---The child's insurance covers telehealth visits.\n\nExclusion Criteria:\n\n-Caregiver does not speak English"}, 'identificationModule': {'nctId': 'NCT05350904', 'briefTitle': 'Hybrid Telehealth in Pediatric Physical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2090371'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hybrid of telehealth and in-person physical therapy services', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie B Hall', 'role': 'CONTACT', 'email': 'halljami@health.missouri.edu', 'phone': '573-884-7531'}], 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'Jamie B Hall, PT, DPT, PhD', 'role': 'CONTACT', 'email': 'halljami@health.missouri.edu', 'phone': '5738847531'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Teaching Professor', 'investigatorFullName': 'Jamie Hall', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}