Virtually Assisted Home Rehabilitation After Acute Stroke-2

NCT ID: NCT05737524

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2024-01-26

Brief Summary

The purpose of this study is to assess feasibility of a virtual rehabilitation program in stroke patients and to assess treatment effects, patient goal attainment with self-guided rehabilitation activities, barriers to and facilitators of telerehab, hospital readmission events, and social determinants of health

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telerehabilitation (VAST 2)

Group Type: EXPERIMENTAL

Telerehabilitation (VAST 2)

Intervention Type: OTHER

The telehealth platform will be available by a web secure link accessible on a home computer or loaded on user friendly tablets that are customized for the patient's impairments. Telerehabilitation services will include 2 out of 3 disciplines: Occupational Therapy, Speech Therapy, Physical Therapy. All therapy interventions will be delivered by licensed therapists and will be based on patients' specific impairments and goals. Therapy intervention will be provided 3x/wk. for each of 2 disciplines. The intervention will be going on for 4 weeks which will total to 24 sessions. Self-management support with trained health coach will be integrated into 1 therapy session each week. An additional individual 30 minute session will occur with the health coach each week.

Interventions

Telerehabilitation (VAST 2)

The telehealth platform will be available by a web secure link accessible on a home computer or loaded on user friendly tablets that are customized for the patient's impairments. Telerehabilitation services will include 2 out of 3 disciplines: Occupational Therapy, Speech Therapy, Physical Therapy. All therapy interventions will be delivered by licensed therapists and will be based on patients' specific impairments and goals. Therapy intervention will be provided 3x/wk. for each of 2 disciplines. The intervention will be going on for 4 weeks which will total to 24 sessions. Self-management support with trained health coach will be integrated into 1 therapy session each week. An additional individual 30 minute session will occur with the health coach each week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent provided by the subject or legally authorized representative.
• Diagnosed with hemorrhagic or ischemic stroke
• Pre-stroke mRS is less than 3
• Qualifying Stroke Event must be confirmed by CT or MRI
• Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
• Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
• Able to access the internet
• Mild-moderate impairments in motor or cognitive function

Exclusion Criteria

• History of neurological or other disease resulting in significant functional impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality).
• Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
• Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lone Star Stroke Consortium

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Sean Savitz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Savitz, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-22-1005

Identifier Type: -

Identifier Source: org_study_id